DUBLIN, Aug. 19, 2020 /PRNewswire/ -- The "3D Cell Cultures: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.

The report includes:

Whether the discussion is about stem cells, tissue engineering, or microphysiological systems, their vital role in drug discovery, toxicology, and other areas leading to new product development, 3D cell culture is becoming the environment that will increasingly define the basis for future advances.

To mix metaphors, 3D cell culture is also cross-roads through which just about everything else passes on its way to building knowledgebases or introducing new products. This study is needed to bring together and make sense out of the broad body of information encompassed by 3D cell culture.

Three-dimensional cell culture has been used by researchers for many years now, with early adoption and now key roles in cancer and stem cells. Organ-on-a-chip technology, also known as microphysiological systems, is leading to dramatic breakthroughs. Also, stem cell research coupled with synthetic biology is opening new areas. This study is needed to provide a perspective on these advances.

Furthermore, classical toxicology testing programs have been in place for many decades, and over the past 20 years, animal welfare and scientific activities have spurred the development of in vitro testing methods. In silico methods are advancing in novel ways that need to be analyzed and considered in terms of their impacts on cell culture.

This report investigates the recent key technical advances in 3D cell culture equipment, raw materials, assay kits, analytical methods, and clinical research organization (CRO) services. It should also be pointed out that this report takes a somewhat different position on 2D cell culture. It has been criticized for its inadequacies and the misleading information it can produce. However, a review of industry practices makes it clear that it still has its place and will contribute to future advances in unexpected ways.

The company section looks at many of the suppliers who provide equipment, assays, cells, reagents, and services used in 3D cell culture. This study sought to understand business models and market maturity dynamics in greater depth as well as providing more quantitative analysis of their operations.

Key Topics Covered

Chapter 1 Introduction

Chapter 2 Summary

Chapter 3 Highlights and Issues

Chapter 4 Tissue and Cell Culture: Technology and Product Background

Chapter 5 Assays, Imaging and Analysis

Chapter 6 Regulation and Standardization

Chapter 7 3D Models for Cancer

Chapter 8 Landscape for Toxicology and Drug Safety Testing

Chapter 9 Stem Cell Landscape

Chapter 10 Regenerative Medicine: Organ Transplants and Skin Substitutes

Chapter 11 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/jesu26

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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3D Cell Cultures Industry Report 2020-2025: Impact of COVID-19 on the World of Cell Culture - PRNewswire

Skin Stem Cells Comments Off on 3D Cell Cultures Industry Report 2020-2025: Impact of COVID-19 on the World of Cell Culture – PRNewswire | August 19th, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Aug 19, 2020--

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy (cisplatin plus 5-fluorouracil [5-FU]), met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with locally advanced or metastatic esophageal cancer. Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared with chemotherapy (cisplatin plus 5-FU), the current standard of care, in the intention-to-treat (ITT) population. The study also met the key secondary endpoint of objective response rate (ORR), with significant improvements for KEYTRUDA in combination with chemotherapy compared with chemotherapy alone. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be shared with global regulatory authorities and have been submitted for presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Esophageal cancer is a devastating malignancy with a high mortality rate and few treatment options in the first-line setting beyond chemotherapy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. In this pivotal study, KEYTRUDA plus chemotherapy resulted in superior overall survival compared with the current standard of care in the full study population and across all patient groups evaluated. These results build upon our research reinforcing the survival benefits of KEYTRUDA, and we look forward to engaging regulatory authorities as quickly as possible.

KEYTRUDA is currently approved in the U.S. and China as monotherapy for the second-line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] 10). Merck is continuing to study KEYTRUDA across multiple settings and stages of gastrointestinal cancer including gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers through its broad clinical program.

About KEYNOTE-590

KEYNOTE-590 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03189719 ) evaluating KEYTRUDA in combination with chemotherapy compared with placebo plus chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal carcinoma (adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type 1 adenocarcinoma of the esophagogastric junction). The primary endpoints are OS and PFS. The secondary endpoints include ORR, duration of response and safety. The study enrolled 749 patients who were randomized to receive:

About Esophageal Cancer

Esophageal cancer, a type of cancer that is particularly difficult to treat, begins in the inner layer (mucosa) of the esophagus and grows outward. The two main types of esophageal cancer are squamous cell carcinoma and adenocarcinoma. Esophageal cancer is the seventh most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. Globally, it is estimated there were more than 572,000 new cases of esophageal cancer diagnosed and nearly 509,000 deaths resulting from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 18,500 new cases of esophageal cancer diagnosed and more than 16,000 deaths resulting from the disease in 2020.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

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Merck's KEYTRUDA (pembrolizumab) in Combination With Chemotherapy Significantly Improved Overall Survival and Progression-Free Survival Compared With...

Skin Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) in Combination With Chemotherapy Significantly Improved Overall Survival and Progression-Free Survival Compared With… | August 19th, 2020

Wild parsnip

A reader wrote last week how she had been trying for a couple of years to identify a tall yellow-flowered roadside weed until someone told her it was wild parsnip. Unable to find much information about it, she turned to this column.

Wild parsnip, Pastinaca sativa, is among the rapidly increasing weeds in many areas. As wild parsnip has spread, so has the realization that human exposure often leads to serious burns and blisters on the arms and legs. Being able to readily identify wild parsnip and early detection of infested areas will minimize inadvertent and excessive exposure to this plant and the often painful results that follow.

The species is native to Eurasia, and may have been introduced as a vegetable as plants have long, thick, white to yellowish taproots that are edible. True parsnip plants have larger roots than wild parsnip. The entire plant has a parsnip odor. Cattle will not eat wild parsnip but deer may feed on it, and birds and small mammals eat the seeds.

The plants are most abundant in sites dominated by perennial grasses that are mowed once or twice a year.

Why the explosion of wild parsnip? Only Mother Nature knows for sure. Birds and mammals eat the seeds and they may be spreading the problem from site to site. There is no doubt that the delay in mowing roadsides until mid summer as an official roadside management policy of the state and towns opens the door for this plant to complete its life cycle, and produce ripe seeds well before any mowing is done. Wild parsnip is tolerant of a wide range of conditions, including dry and wet areas. It is shade tolerant, but prefers sunny conditions. Depending on the habitat and growing conditions, individual flowering plants range to over four feet in height.

Also, when roadsides and pastures are mowed in July and August, parsnip seeds probably move as hitchhikers on the mowers. Mowing also creates a much more favorable environment for parsnip seeds to germinate than if the sites were left undisturbed. Relatively mild winters may enhance survival of wild parsnip plants that germinate and become established in the fall.

Wild parsnip has a long germination period, but the optimum time for germination is in the early spring, and that is when most germination occurs. Most fall germinated seedlings die during winter. Wild parsnip seedlings are among the first plants to greenup early in the spring.

Rosettes grow close to the ground and bear leaves averaging six inches in height. Flowering plants produce a single, thick stem that contains hundreds of yellow umbellate flowers. The lateral flowers often overtop the terminal flowers.

But, the most important thing for humans to remember is to avoid contact with the plant. Humans develop a severe skin irritation from contact with its leaves. Plants have chemicals called psoralens that cause an interaction between plant and light that induce skin inflammation.

Experts are warning people to stay away from wild parsnip after a Vermont woman was severely burned after being exposed to the sap.

The plant grows along rural roads and in meadows throughout the state. Wild parsnip is not native to Maine and has a deep vertical ridge on its stalk. The flowers come in clusters of tiny yellow flowers similar to Queen Annes Lace.

A woman in Vermont fell into a wild parsnip plant and suffered horrific burns after her legs were exposed to the sap and she spent time in the sun.

It is soluble, said Maine State Horticulturist Gary Fish. It goes into the skin and thats when you are going to have damage to the skin which turns into blisters when you have sun exposure.

People walking through vegetation should wear long sleeves and pants and stay away from plants that look like wild parsnips.

Wild parsnip has sap that has psoralens in it naturally occurring organic compounds that can kill skin cells that protect people from ultraviolet radiation. When the sap touches the body, it can cause blisters and symptoms resembling symptoms from a burn.

Once the sap is absorbed by the skin, they are energized by UV light on both sunny and cloudy days. They then bind to DNA and cell membranes, destroying cells and skin. Parsnip burns usually occur in streaks and elongated spots, reflecting where a damaged leaf or stem moved across the skin before exposure to sunlight.

Wild parsnip burns differ from the rash caused by poison ivy in several aspects. First, everyone is sensitive to wild parsnip and you do not need to be sensitized by a prior exposure to develop burns or blisters. You can brush against wild parsnip plants and not be affected. Parsnip is dangerous only when the plant sap from broken leaves or stems gets on your skin. Lastly, the parsnip burn is usually less irritating than poison ivys itch.

After about 3 days, the symptoms start to get better. Eventually, like after a bad sunburn, the burned skin cells die and flake off. As symptoms improve, the rash may appear lighter or darker. Discoloration and sensitivity to sunlight in the affected areas can remain for up to two years.

Wild parsnip grows abundantly on our roadsides. Some people mistake it as ragweed, and rightfully so. There is, however, many dissimilarities once you see them side by side.

If you develop a rash or blisters, go to the hospital or a clinic for treatment.

There are other plants in the family that can be harmful as well: Cow Parsnip, a native plant, with white flowers; Giant Hogweed, an invasive species, with white flowers similar to cow parsnip.

When it comes to wild parsnip, unless you are absolutely sure it is something else, dont touch it.

In 1975, the Red Sox played the Cincinnati Reds in what is called the Greatest World Series ever. Who hit an eighth inning three-run homer in game 6 to tie the score, and set up Carlton Fisks 12th inning iconic home run?

Answer can be found here.

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SCORES & OUTDOORS - Be cautious of the wild parsnip - Town Line

Skin Stem Cells Comments Off on SCORES & OUTDOORS – Be cautious of the wild parsnip – Town Line | August 19th, 2020

New York, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Hydrogels Industry" - https://www.reportlinker.com/p05896103/?utm_source=GNW Strong R&D interest is already underway for hydrogel biomaterials. New developments in hydrogel design and hydrogel synthesis are resulting in the development of hydrogels with mechanical properties. Superporous comb-type grafted hydrogels with fast response times; hybrid graft copolymers based self-assembling hydrogels; protein based hydrogels and hybrid hydrogels are the emerging new future of smart hydrogel based biomaterials. Stimuli-sensitive hydrogels, especially polypeptide based responsive hydrogels hold promising potential. Protein hydrogel are more biocompatible than synthetic hydrogel as they do not require the use of oxic chemical crosslinkers. This represents a key growth opportunity in the market given that traditional hydrogels have been largely limited by their poor mechanical properties and slow response times to stimuli. Temperature-sensitive hydrogels especially will find attractive opportunities in biomedicine.

Wound dressings currently remain a popular application area with hydrogel being effective for treating dry necrotic wounds and rapid healing of burn wounds. Hydrogel enables painless debridement of infected tissue and provides a moist wound environment for faster healing. Chitosan-based hydrogels, in this regard, are growing in popularity for their biocompatible, antimicrobial, and hemostatic effects. Acellular Hydrogel is especially valuable in accelerated healing of third-degree burn wounds and is a welcome substitute for complicated and infection prone skin grafts. Encouraging progress is being made in the use of hydrogels for targeted & controlled drug delivery. Hydrogels can prolong drug release kinetics. Their porosity and aqueous features make them perfect biocompatible drug delivery vehicles. Chitosan-based hydrogels can be loaded with active drug compounds like growth factors or stem cells that are important in providing scaffold for cell growth. The growing focus on controlled and targeted drug delivery systems in the field of cardiology, oncology, immunology, and pain management bodes well for future growth in the market. Some of the physical properties of hydrogel that can be manipulated and tuned to suit drug delivery needs include porosity, swelling and elasticity in response to stimuli such as temperature, solvent quality, pH, electric field; resistance to dissolution; free diffusion of solute molecules in water; among others. These properties help in controlled drug release and protect from drug degradation, thereby making them highly effective vehicles for drug delivery systems. Some of the types of hydrogels development for drug delivery include DNA-hydrogels; supramolecular hydrogels; bio-inspired hydrogels; and multi-functional and stimuli-responsive hydrogels. New emerging uses in contact lenses and tissue engineering will also benefit growth in the market in the coming years. The United States and Europe represent large markets worldwide with a combined share of 52.4% of the market. China ranks as the fastest growing market with a CAGR of 7.3% over the analysis period supported by the governments focus on revolutionizing biomedical engineering in the country. The country today ranks as the top country for biomedical research encouraged by a permissive regulatory climate.

Read the full report: https://www.reportlinker.com/p05896103/?utm_source=GNW

I. INTRODUCTION, METHODOLOGY & REPORT SCOPE

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW Expanding Applications and Product Innovations Spur Growth in the Global Hydrogel Market Emerging Economies to Post Strong Growth Industry Witnesses Rise in Demand for Synthetic Hydrogels Synthetic Hydrogels by Polymer Type: A Snapshot Global Competitor Market Shares Hydrogel Competitor Market Share Scenario Worldwide (in %): 2019 Hydrogel Competitor Market Share Scenario Worldwide (in %): 2019

2. FOCUS ON SELECT PLAYERS 3M Company (USA) ACELITY L.P, Inc. (USA) Ashland, Inc. (USA) Braun Melsungen AG (Germany) Cardinal Health, Inc. (USA) Coloplast A/S (Denmark) ConvaTec, Inc. (USA) Integra LifeSciences Holdings Corporation (USA) Evonik Industries AG (Germany) Gentell, Inc. (USA) Hollister, Inc. (USA) Mlnlycke Health Care AB (Sweden) Ocular Therapeutix, Inc. (USA) Sekisui Plastics Co. Ltd. (Japan) Smith & Nephew, Plc (UK)

3. MARKET TRENDS & DRIVERS Innovations Expand Addressable Market for Hydrogels Rise in Incidence of Chronic Diseases and High Treatment Costs Drive Demand for Hydrogel Dressings for Wound Healing Global Prevalence of Wounds Global Wound Care Market: Percentage Breakdown of Spending by Wound Type Personal Care Product: An Evolving Niche Market Global Skin Care Market Size in US$ Billion for the Years 2019, 2021, 2023 and 2025 Consumer Adoption of Hydrogel Contact Lenses Augurs Well for Market Growth Global Contact Lens Fits by Category (In %): 2019 Hydrogels Evolve as Emerging Alternative for Food Packaging Agriculture Sector Depicts Strong Growth Potential Global Water Utilization: Percentage Share Breakdown for Agricultural Practices, Industrial Processes, and Domestic Usage Rising Concerns over Polluting Water Resources: An Opportunity for Hydrogels Market Need for Wastewater Treatment Presents Opportunity for Hydrogels: Percentage of Wastewater Treated in Europe, Asia, Latin America, and Africa Growing Emphasis on Sustainability and Positive Impact on Hydrogels Growth in Biomedical Applications of Hydrogels Hydrogels for Cartilage Regeneration Growing Need for Targeted Controlled Drug Delivery (TCDD) Drives Importance of Hydrogels Hydrogel Nanoparticles: The New Hydrogels for Drug Delivery Evaporative Cooling Hydrogel Packaging: Increasing Storage Stability of Pharmaceuticals Growing Focus on Baby Hygiene Products Spells Steady Growth Opportunities for Hydrogels Annual Usage of Baby Disposable Diapers Per Infant by Region: ( Age upto 2.5 years) Global New Births (in Millions) per Annum by Geographic Region World Fertility Rate in % by Region (2013 & 2050F) Increased Demand for Feminine Hygiene Products Global Female Population by Geographic Region: Percentage Breakdown by Region for 2018 Number of Menstruating Women Worldwide by Country: 15-49 Years Female Population (in Millions) for 2013 & 2025P Aging Population and the Associated Complications Drive the Demand for Hydrogel Global Population Statistics for the 65+ Age Group in Million by Geographic Region for the Years 2019, 2025, 2035 and 2050 Rise in Demand for Novel Hydrogel Dressings for Wound Healing Propels Innovations PRODUCT OVERVIEW Hydrogel Types of Hydrogel Natural Hydrogels Select Natural Hydrogels: Advantages and Disadvantages Synthetic Hydrogels Select Synthetic Hydrogels: Advantages and Disadvantages Hybrid Hydrogels

4. GLOBAL MARKET PERSPECTIVE Table 1: Hydrogels Global Market Estimates and Forecasts in US$ Thousand by Region/Country: 2020-2027

Table 2: Hydrogels Global Retrospective Market Scenario in US$ Thousand by Region/Country: 2012-2019

Table 3: Hydrogels Market Share Shift across Key Geographies Worldwide: 2012 VS 2020 VS 2027

Table 4: Natural (Raw Material) World Market by Region/Country in US$ Thousand: 2020 to 2027

Table 5: Natural (Raw Material) Historic Market Analysis by Region/Country in US$ Thousand: 2012 to 2019

Table 6: Natural (Raw Material) Market Share Breakdown of Worldwide Sales by Region/Country: 2012 VS 2020 VS 2027

Table 7: Synthetic (Raw Material) Potential Growth Markets Worldwide in US$ Thousand: 2020 to 2027

Table 8: Synthetic (Raw Material) Historic Market Perspective by Region/Country in US$ Thousand: 2012 to 2019

Table 9: Synthetic (Raw Material) Market Sales Breakdown by Region/Country in Percentage: 2012 VS 2020 VS 2027

Table 10: Hybrid (Raw Material) Geographic Market Spread Worldwide in US$ Thousand: 2020 to 2027

Table 11: Hybrid (Raw Material) Region Wise Breakdown of Global Historic Demand in US$ Thousand: 2012 to 2019

Table 12: Hybrid (Raw Material) Market Share Distribution in Percentage by Region/Country: 2012 VS 2020 VS 2027

Table 13: Polyacrylate (Composition) World Market Estimates and Forecasts by Region/Country in US$ Thousand: 2020 to 2027

Table 14: Polyacrylate (Composition) Market Historic Review by Region/Country in US$ Thousand: 2012 to 2019

Table 15: Polyacrylate (Composition) Market Share Breakdown by Region/Country: 2012 VS 2020 VS 2027

Table 16: Polyacrylamide (Composition) World Market by Region/Country in US$ Thousand: 2020 to 2027

Table 17: Polyacrylamide (Composition) Historic Market Analysis by Region/Country in US$ Thousand: 2012 to 2019

Table 18: Polyacrylamide (Composition) Market Share Distribution in Percentage by Region/Country: 2012 VS 2020 VS 2027

Table 19: Silicon (Composition) World Market Estimates and Forecasts in US$ Thousand by Region/Country: 2020 to 2027

Table 20: Silicon (Composition) Market Worldwide Historic Review by Region/Country in US$ Thousand: 2012 to 2019

Table 21: Silicon (Composition) Market Percentage Share Distribution by Region/Country: 2012 VS 2020 VS 2027

Table 22: Other Compositions (Composition) Market Opportunity Analysis Worldwide in US$ Thousand by Region/Country: 2020 to 2027

Table 23: Other Compositions (Composition) Global Historic Demand in US$ Thousand by Region/Country: 2012 to 2019

Table 24: Other Compositions (Composition) Market Share Distribution in Percentage by Region/Country: 2012 VS 2020 VS 2027

Table 25: Agriculture (Application) Worldwide Sales in US$ Thousand by Region/Country: 2020-2027

Table 26: Agriculture (Application) Historic Demand Patterns in US$ Thousand by Region/Country: 2012-2019

Table 27: Agriculture (Application) Market Share Shift across Key Geographies: 2012 VS 2020 VS 2027

Table 28: Healthcare & Hygiene (Application) Global Market Estimates & Forecasts in US$ Thousand by Region/Country: 2020-2027

Table 29: Healthcare & Hygiene (Application) Retrospective Demand Analysis in US$ Thousand by Region/Country: 2012-2019

Table 30: Healthcare & Hygiene (Application) Market Share Breakdown by Region/Country: 2012 VS 2020 VS 2027

Table 31: Contact Lenses (Application) Demand Potential Worldwide in US$ Thousand by Region/Country: 2020-2027

Table 32: Contact Lenses (Application) Historic Sales Analysis in US$ Thousand by Region/Country: 2012-2019

Table 33: Contact Lenses (Application) Share Breakdown Review by Region/Country: 2012 VS 2020 VS 2027

Table 34: Drug Delivery (Application) Worldwide Latent Demand Forecasts in US$ Thousand by Region/Country: 2020-2027

Table 35: Drug Delivery (Application) Global Historic Analysis in US$ Thousand by Region/Country: 2012-2019

Table 36: Drug Delivery (Application) Distribution of Global Sales by Region/Country: 2012 VS 2020 VS 2027

Table 37: Tissue Engineering (Application) Sales Estimates and Forecasts in US$ Thousand by Region/Country for the Years 2020 through 2027

Table 38: Tissue Engineering (Application) Analysis of Historic Sales in US$ Thousand by Region/Country for the Years 2012 to 2019

Table 39: Tissue Engineering (Application) Global Market Share Distribution by Region/Country for 2012, 2020, and 2027

Table 40: Other Applications (Application) Global Opportunity Assessment in US$ Thousand by Region/Country: 2020-2027

Table 41: Other Applications (Application) Historic Sales Analysis in US$ Thousand by Region/Country: 2012-2019

Table 42: Other Applications (Application) Percentage Share Breakdown of Global Sales by Region/Country: 2012 VS 2020 VS 2027

III. MARKET ANALYSIS

GEOGRAPHIC MARKET ANALYSIS

UNITED STATES Table 43: United States Hydrogels Market Estimates and Projections in US$ Thousand by Raw Material: 2020 to 2027

Table 44: Hydrogels Market in the United States by Raw Material: A Historic Review in US$ Thousand for 2012-2019

Table 45: United States Hydrogels Market Share Breakdown by Raw Material: 2012 VS 2020 VS 2027

Material: 2012 VS 2020 VS 202

Table 47: Hydrogels Market in the United States by Composition: A Historic Review in US$ Thousand for 2012-2019

Table 48: United States Hydrogels Market Share Breakdown by Composition: 2012 VS 2020 VS 2027

Table 49: United States Hydrogels Latent Demand Forecasts in US$ Thousand by Application: 2020 to 2027

Table 50: Hydrogels Historic Demand Patterns in the United States by Application in US$ Thousand for 2012-2019

Table 51: Hydrogels Market Share Breakdown in the United States by Application: 2012 VS 2020 VS 2027

CANADA Table 52: Canadian Hydrogels Market Estimates and Forecasts in US$ Thousand by Raw Material: 2020 to 2027

Table 53: Canadian Hydrogels Historic Market Review by Raw Material in US$ Thousand: 2012-2019

Table 54: Hydrogels Market in Canada: Percentage Share Breakdown of Sales by Raw Material for 2012, 2020, and 2027

Table 55: Canadian Hydrogels Market Estimates and Forecasts in US$ Thousand by Composition: 2020 to 2027

Table 56: Canadian Hydrogels Historic Market Review by Composition in US$ Thousand: 2012-2019

Table 57: Hydrogels Market in Canada: Percentage Share Breakdown of Sales by Composition for 2012, 2020, and 2027

Table 58: Canadian Hydrogels Market Quantitative Demand Analysis in US$ Thousand by Application: 2020 to 2027

Table 59: Hydrogels Market in Canada: Summarization of Historic Demand Patterns in US$ Thousand by Application for 2012-2019

Table 60: Canadian Hydrogels Market Share Analysis by Application: 2012 VS 2020 VS 2027

JAPAN Table 61: Japanese Market for Hydrogels: Annual Sales Estimates and Projections in US$ Thousand by Raw Material for the Period 2020-2027

Table 62: Hydrogels Market in Japan: Historic Sales Analysis in US$ Thousand by Raw Material for the Period 2012-2019

Table 63: Japanese Hydrogels Market Share Analysis by Raw Material: 2012 VS 2020 VS 2027

Table 64: Japanese Market for Hydrogels: Annual Sales Estimates and Projections in US$ Thousand by Composition for the Period 2020-2027

Table 65: Hydrogels Market in Japan: Historic Sales Analysis in US$ Thousand by Composition for the Period 2012-2019

Table 66: Japanese Hydrogels Market Share Analysis by Composition: 2012 VS 2020 VS 2027

Table 67: Japanese Demand Estimates and Forecasts for Hydrogels in US$ Thousand by Application: 2020 to 2027

Table 68: Japanese Hydrogels Market in US$ Thousand by Application: 2012-2019

Table 69: Hydrogels Market Share Shift in Japan by Application: 2012 VS 2020 VS 2027

CHINA Table 70: Chinese Hydrogels Market Growth Prospects in US$ Thousand by Raw Material for the Period 2020-2027

Table 71: Hydrogels Historic Market Analysis in China in US$ Thousand by Raw Material: 2012-2019

Table 72: Chinese Hydrogels Market by Raw Material: Percentage Breakdown of Sales for 2012, 2020, and 2027

Table 73: Chinese Hydrogels Market Growth Prospects in US$ Thousand by Composition for the Period 2020-2027

Table 74: Hydrogels Historic Market Analysis in China in US$ Thousand by Composition: 2012-2019

Table 75: Chinese Hydrogels Market by Composition: Percentage Breakdown of Sales for 2012, 2020, and 2027

Table 76: Chinese Demand for Hydrogels in US$ Thousand by Application: 2020 to 2027

Table 77: Hydrogels Market Review in China in US$ Thousand by Application: 2012-2019

Table 78: Chinese Hydrogels Market Share Breakdown by Application: 2012 VS 2020 VS 2027

EUROPE Table 79: European Hydrogels Market Demand Scenario in US$ Thousand by Region/Country: 2020-2027

Table 80: Hydrogels Market in Europe: A Historic Market Perspective in US$ Thousand by Region/Country for the Period 2012-2019

Table 81: European Hydrogels Market Share Shift by Region/Country: 2012 VS 2020 VS 2027

Table 82: European Hydrogels Market Estimates and Forecasts in US$ Thousand by Raw Material: 2020-2027

Table 83: Hydrogels Market in Europe in US$ Thousand by Raw Material: A Historic Review for the Period 2012-2019

Table 84: European Hydrogels Market Share Breakdown by Raw Material: 2012 VS 2020 VS 2027

Table 85: European Hydrogels Market Estimates and Forecasts in US$ Thousand by Composition: 2020-2027

Table 86: Hydrogels Market in Europe in US$ Thousand by Composition: A Historic Review for the Period 2012-2019

Table 87: European Hydrogels Market Share Breakdown by Composition: 2012 VS 2020 VS 2027

Table 88: European Hydrogels Addressable Market Opportunity in US$ Thousand by Application: 2020-2027

Table 89: Hydrogels Market in Europe: Summarization of Historic Demand in US$ Thousand by Application for the Period 2012-2019

Table 90: European Hydrogels Market Share Analysis by Application: 2012 VS 2020 VS 2027

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The global market for Hydrogel is projected to reach US$15.3 billion by 2025 - GlobeNewswire

Skin Stem Cells Comments Off on The global market for Hydrogel is projected to reach US$15.3 billion by 2025 – GlobeNewswire | August 18th, 2020

An exclusive market study published by Fact.MR on the Autologous Fat Grafting market offers insights related to how the market is projected to grow over the forecast period (2019-2029). The objective of the report is to enable our readers to understand the various aspects of the Autologous Fat Grafting market and assist them to formulate impactful business strategies. Furthermore, the different factors that are expected to influence the current and future dynamics of the Autologous Fat Grafting market are discussed in the presented study.

According to the report, the Autologous Fat Grafting market is set to reach a market value of ~US$ XX by the end of 2029 and register a CAGR growth of ~XX% during the assessment period. The report offers an in-depth understanding of the Autologous Fat Grafting supply chain, value, and volume chain across the various regional markets.

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Autologous Fat Grafting Market Segmentation

By Region

The regional analysis of the Autologous Fat Grafting market dives deep to understand the market scenario in different regions. The market size, share, and value of each regional market is analyzed and presented in the report along with informative tables and figures.

By Application

The report offers a clear picture of how the Autologous Fat Grafting is utilized in various applications. The different applications covered in the report include:

By End-Use Industry

The end-use industry assessment throws light on the consumption of the Autologous Fat Grafting across various end-use industries including:

Competition Landscape

The four leading companies that account for the consolidation of the competition landscape of autologous fat grafting market, continue to represent a whopping 80% share in the revenues. Allergan, MicroAire, Alma Lasers, and Human Med are expected to primarily maintain their strategic focus on partnerships and acquisitions with smaller yet active players. The latter are typically specialized in the development of meniscus repair systems for treating meniscal scars. With this, leading companies operating in autologous fat grafting industry, are eyeing feasibility of entry in the meniscal scars treatment landscape. Increasing strategic tie-ups among manufacturers of systems & accessories, and recognized research institutions, aim to ensure sufficient device supply and superior post-sales service.

Manufacturers in the autologous fat grafting market are also investing efforts in introducing innovative products, to enhance their market shares. For instance, in 2019, Alma Lasers (Sisram Medical) announced the availability of BeautiFill as the novel laser-based technique for fat harvesting, while leveraging autologous fat to restore the volume to body or face. As cellular therapies are increasingly being perceived as mainstream therapeutic option, there has been a surge in demand for adipose derived stem cells (ADSC), which is potentially applicable in tissue engineering and regeneration. Additionally, a growing focus of leading players on introducing advanced systems & accessories is likely to extend applicability of their offerings, leveraging untapped opportunities in the autologous fat grafting market.

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Key Factors Shaping Autologous Fat Grafting Market

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Key Challenges Facing Autologous Fat Grafting Market

Additional Insight

Biomaterial Research to Open Doors to Multiple Opportunities

Autologous fat grafting technique continues to witness frequent technical modifications. The adoption of autologous fat grafting as a technique to augment and regenerate deficient, irradiated, and aged subcutaneous soft tissue and skin, with minimal complication rate and donor-site morbidity, has grown spectacularly over the recent past. An approach garnering research interests for its potential role in enhancing volumetric retention of fat grafts, involves insertion of autologous platelet-rich fibrin (PRF) into graft tissues. A relevant study indicates PRF as a concentrate that may enhance the outcome of fat grafting for plastic surgery procedures. This newer biomaterial with several potential advantages, such as simpler preparation with no external additive, is likely to trigger new product developments in the autologous fat grafting market.

Autologous Fat Grafting Market Research Methodology

A patented research methodology and a holistic approach form the base of the insightful information provided in the autologous fat grafting market report. This study provides detailed information about the key factors associated with the growth of autologous fat grafting market and presents a systematic breakdown of the factors shaping the progress of market. Detailed primary and secondary research has been done to offer information about the historic and prospective analysis of fat grafting industry, with emphasis on the autologous fat grafting procedure. The report on autologous fat grafting market has also gone through several validation tunnels to guarantee the uniqueness of the insights and key growth influencers, covered in the report.

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Autologous Fat Grafting Expected to Expand at a Steady CAGR through 2019 to 2029 - Scientect

Skin Stem Cells Comments Off on Autologous Fat Grafting Expected to Expand at a Steady CAGR through 2019 to 2029 – Scientect | August 18th, 2020

The global market for cell harvesting should grow from $885 million in 2018 to reach $1.5 billion by 2023 at a compound annual growth rate (CAGR) of 11.3% for the period of 2018-2023.

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Report Scope:

The scope of the report encompasses the major types of cell harvesting that have been used and the cell harvesting technologies that are being developed by industry, government agencies and nonprofits. It analyzes current market status, examines drivers on future markets and presents forecasts of growth over the next five years.

The report provides a summary of the market, including a market snapshot and profiles of key players in the cell harvesting market. It provides an exhaustive segmentation analysis of the market with in-depth information about each segment. The overview section of the report provides a description of market trends and market dynamics, including drivers, restraints and opportunities. it provides information about market developments and future trends that can be useful for organizations, including wholesalers and exporters. It provides market positionings of key players using yardsticks of revenue, product portfolio, and recent activities. It further includes strategies adopted by emerging market players with strategic recommendations for new market entrants. Readers will also find historical and current market sizes and a discussion of the markets future potential. The report will help market players and new entrants make informed decisions about the production and exports of goods and services.

Report Includes:

41 data tables and 22 additional tables Description of segments and dynamics of the cell harvesting market Analyses of global market trends with data from 2017, 2018, and projections of compound annual growth rates (CAGRs) through 2023 Characterization and quantification of market potential for cell harvesting by type of harvesting, procedure, end user, component/equipment and region A brief study and intact information about the market development, and future trends that can be useful for the organizations involved in Elaboration on the influence of government regulations, current technology, and the economic factors that will shape the future marketplace Key patents analysis and new product developments in cell harvesting market Detailed profiles of major companies of the industry, including Becton, Dickinson and Co., Corning, Inc., Fluidigm Corp., General Electric Co., Perkinelmer, Inc., and Thermo Fisher Scientific, Inc.

Summary

Stem cells are unspecialized cells that have the ability to divide indefinitely and produce specialized cells. The appropriate physiological and experimental conditions provided to the unspecialized cells give rise to certain specialized cells, including nerve cells, heart muscle cells and blood cells. Stem cells can divide and renew themselves over long periods of time. These cells are extensively found in multicellular organisms, wherein mammals, there are two types of stem cells embryonic stem cells and adult stemcells. Embryonic stem cells are derived from a human embryo four or five days old that is in the blastocyst phase of development. Adult stem cells grow after the development of the embryo and are found in tissues such as bone marrow, brain, blood vessels, blood, skin, skeletal muscles and liver. Stemcell culture is the process of harvesting the exosomes and molecules released by the stem cells for the development of therapeuticsfor chronic diseases such as cancer and diabetes.

The process is widely used in biomedical applications such as therapy, diagnosis and biological drug production. The global cell harvesting market is likely to witness a growth rate of REDACTED during the forecast period of 2018-2023.The value of global cell harvesting market was REDACTED in 2017 and is projected to reach REDACTED by 2023. Market growth is attributed to factors such as increasing R&D spending in cell-based research,the introduction of 3D cell culture technology, increasing government funding, and the growing prevalence of chronic diseases such as cancer and diabetes.

The growing incidence and prevalence of cancer is seen as one of the major factors contributing to the growth of the global cell harvesting market. According to the World Health Organization (WHO), cancer is the second-leading cause of mortality globally and was responsible for an estimated 9.6 million deaths in 2018. Therefore, there is an increasing need for effective cancer treatment solutions globally. Cell harvesting is the preferred method used in cancer cell-related studies including cancer cell databases (cancer cell lines), and other analyses and drug discovery in a microenvironment.

The rising prevalence of such chronic diseases has led governments to provide R&D funding to research institutes and biotechnology companies to develop advanced therapeutics. Various 3D cell culture technologies have been developed by researchers and biotechnology companies such as Lonza Group and Thermo Fischer Scientific for research applications such as cancer drug discovery. The application of cell culture in cancer research is leading to more predictive models for research, drug discovery and regenerative medicine applications.

Platelet-rich plasma (PRP) therapy, a new biotechnology solution that has a heightened interest among researchers in tissue engineering and cell-based therapies, has various applications in the treatment of tissue healing in tendinopathy, osteoarthritis and muscle injury. It has been conventionally employed in orthopedics, maxillofacial surgery, periodontal therapy and sports medicines. PRP therapy can be used in the treatment of fat grafting, acne scars, and hair regrowth.

Major factors driving market growth include increasing healthcare costs and the high rate of adoption for modern medicines in emerging economies such as China and India. It has been estimated that India will witness a CAGR of REDACTED in the cell harvesting market during the forecast period. The active participation of foreign pharmaceutical companies has tapped the Indian healthcare sector with a series of partnerships and mergers and acquisitions, which in turn is positively impacting the growth of the market in this region.

Consistent development and clinical trials for stem cell therapies, plus contribution from the government and private sectors through investments and cohesive reimbursement policies in the development of cancer biomarkers, is further fueling market growth. InSweden, a research team at Lund University has developed a device to collect fluid and harvest stem mesenchymal stem cells (MSCs). The device is developed with 3D-printed bio-inert plastics which, when used by doctors, can result in the safe extraction of fluids (medical waste) from the patients body. The liquid is then passed through a gauze filter for purifying thoroughly and MSCs are separated from the fluid by centrifugation and are grown in culture.

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Cell Harvesting Market Market Will Grow At CAGR During 2018-2023 Global Evaluation By Trends, Proportions, Share, Swot, And Key Developments -...

Skin Stem Cells Comments Off on Cell Harvesting Market Market Will Grow At CAGR During 2018-2023 Global Evaluation By Trends, Proportions, Share, Swot, And Key Developments -… | August 18th, 2020

XconomyNew York

An FDA advisory committee Thursday voted 9-1 to recommend that the agency approve a stem cell therapy developed by MesoBlast as a treatment for acute graft-versus-host disease (aGVHD) in children. The panel weighed the need for a new way to address the potentially fatal condition against shortcomings of the clinical trial the Australian biotech conducted to evaluate the investigational cell therapy.

Shares in (NASDAQ: MESO), which fell more than 30 percent earlier in the week after the FDA released briefing documents ahead of the committees meeting, closed up 51 percent Friday at $17.88 apiece compared to $11.81 at market close Wednesday. (Trading was halted on Thursday.)

The MesoBlast cell therapy, remestemcel-L (Ryoncil), is made from mesenchymal cells taken from healthy donors. The properties of these cells, which dont prompt an immune reaction, allow them to be used as an off-the-shelf treatment without accompanying immunosuppressants that put patients at greater risk for infection, among other side effects.

Some patients with blood cancer are treated with a stem cell transplant, in which cells from a healthy donor are infused into their bloodstream with the intent that those cells will travel to the bone marrow and form new healthy blood cells. Frequently, however, when donors are unrelated, their cells identify the recipients as foreign, prompting them to attack organs and tissues. Treatment with systemic corticosteroids can help control the severity of the condition. But in up to 90 percent of aGVHD patients who dont respond to steroid treatment, the condition can prove fatal.

MesoBlasts submission was based on a clinical trial that enrolled 55 children age 2 months to 17 years who had received a transplant of bone marrow, peripheral blood stem cells, or cord blood, were diagnosed with aGVDH and werent responding to steroid therapy. The study tracked their responses to remestemcel on day 28. Overall, 70 percent of the patients responded, including 76 percent of the 25 patients whose condition was graded as most severe. On day 100, 74 percent of patients remained alive; on day 180, 69 percent.

However, the trial was neither randomized nor controlled, raising concerns of confounding factors and potential bias. MesoBlast said investigators werent willing to enroll children in such a trial. But the company said randomization and controlled design would be incorporated into a planned post-marketing study in adults.

In previous clinical trials in wider patient populations, the treatment missed the primary goal. Analyses of results from those earlier trials prompted MesoBlasts decision to focus the drugs further development to steroid-refractory pediatric patients. In its presentation to the advisory panel the company said the remestemcel manufacturing process has been improved since those trials in ways that have made the treatment more potent.

The panel voted on whether MesoBlast provided enough clinical data to show that its therapy was effective in treating aGVHD in this narrower group. Panelist Christian Hinrichs, a clinical researcher at the National Cancer Institute and physician by training, was the sole no vote. Nine panelists felt the available data did indicate efficacy. (The committee recorded the tally as 8-2, but a MesoBlast representative said one no vote was made in error.)

I do think that the two prior randomized trials convincingly show that the [earlier version of remestemcel], at least in the population that was being studied, which is similar but not the same, clearly did not have meaningful activity, Hinrichs said. So, you know, do we think that these tweaks to the manufacturing have suddenly made it highly effective, and the change in patient population has suddenly made it highly effective?

Jorge Garcia, division chief of solid tumor oncology at University Hospitals Seidman Cancer Center in Cleveland, however, said while it isnt clear how the treatment compares to other drugs used to treat patients with the condition, the data indicate it is safe and has shown some efficacy.

In May 2019 an Incyte (NASDAQ: INCY) treatment, ruxolitinib (Jakafi), became the first FDA-approved treatment for patients with aGVHD who didnt responded to steroid therapy. Ruxolitinib was OKd for patients starting at age 12. But no treatment is approved for those younger.

Although the FDA considers advisory panel recommendations during drug reviews, committee recommendations are not binding, and the agency doesnt always follow them. Its decision on remestemcel is anticipated by Septembers end.

Image: iStock/Yarygin

Sarah de Crescenzo is an Xconomy editor based in San Diego. You can reach her at sdecrescenzo@xconomy.com.

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Advisory Body Backs MesoBlast Therapy for Transplant Complication - Xconomy

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New Jersey, United States,- The Stem Cell Therapy Market is predicted by Verified Market Researchs report to find players focusing on new product development to secure a strong position in terms of revenue sharing. Strategic collaboration can be a powerful way to bring new products to the market. The level of competition observed in the market may increase.

This research report categorizes the global market by players/brands, regions, types, and applications. The report also analyzes the global market status, competitive landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels, five forces of distributors, and porters.

The latest 2020 edition of this report reserves the right to provide further comments on the latest scenarios, recession, and impact of COVID-19 on the entire industry. It also provides qualitative information on when the industry can rethink the goals the industry is taking to address the situation and possible actions.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Stem Cell Therapy Market Segment Analysis-

The research report includes specific segments by Type and Application. Each type provides information about the production during the forecast period of 2015 to 2027. The application segment also provides consumption during the forecast period of 2015 to 2027. Understanding the segments helps in identifying the importance of different factors that aid market growth.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

The study analyses the following key business aspects:

Analysis of Strategies of Leading Players: Market players can use this analysis to gain a competitive advantage over their competitors in the Stem Cell Therapy market.

Study on Key Market Trends: This section of the report offers a deeper analysis of the latest and future trends of the Stem Cell Therapy market.

Market Forecasts:Buyers of the report will have access to accurate and validated estimates of the total market size in terms of value and volume. The report also provides consumption, production, sales, and other forecasts for the Stem Cell Therapy market.

Regional Growth Analysis:All major regions and countries have been covered in the report. The regional analysis will help market players to tap into unexplored regional markets, prepare specific strategies for target regions, and compare the growth of all regional markets.

Segmental Analysis:The report provides accurate and reliable forecasts of the market share of important segments of the Stem Cell Therapy market. Market participants can use this analysis to make strategic investments in key growth pockets of the Stem Cell Therapy market.

Business Opportunities in Following Regions and Countries:

North America (United States, Canada, and Mexico)

Europe (Germany, UK, France, Italy, Russia, Spain, and Benelux)

Asia Pacific (China, Japan, India, Southeast Asia, and Australia)

Latin America (Brazil, Argentina, and Colombia)

How will the report assist your business to grow?

The document offers statistical data about the value (US $) and size (units) for the Stem Cell Therapy industry between 2020 to 2027.

The report also traces the leading market rivals that will create and influence the Stem Cell Therapy business to a greater extent.

Extensive understanding of the fundamental trends impacting each sector, although greatest threat, latest technologies, and opportunities that could build the global Stem Cell Therapy market both supply and offer.

The report helps the customer to determine the substantial results of major market players or rulers of the Stem Cell Therapy sector.

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Save and reduce time carrying out entry-level research by identifying the growth, size, leading players, and segments in the global Stem Cell Therapy Market. Highlights key business priorities in order to assist companies to realign their business strategies. The key findings and recommendations highlight crucial progressive industry trends in Stem Cell Therapy Market, thereby allowing players to develop effective long term strategies.

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Stem Cell Therapy Market Size By Product Analysis, By Application, By End-Users, By Regional Outlook, By Top Companies and Forecast to 2027 - Bulletin...

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Expectant parents have so many decisions to make before and after their childs birth. Until recently, decisions related to the Umbilical cord blood banking werent one of those.

Back then, the umbilical cord was merely discarded after the birth of the child. Lately, expectant parents are increasingly considering new ways of handling the umbilical cord and the cord blood since new research is beginning to reveal the usefulness of these items.

Cord Blood Explained

The term Cord Blood refers to the type of blood found within the placenta as well as the umbilical cord of a baby. It is usually acquired from the babys umbilical cord after being birthed. The cord blood, as well as its tissues, has an ample amount of stem cells and other important cells. Due to its biological and chemical properties, it is now considered a life-saving treatment for various health conditions.

For instance, some medical experts now say that cord blood is useful for treating over 80 health conditions and disorders. Another game-changing element to it is its usefulness for conditions that require bone marrow transplant. Also, stem cells from the cord blood rarely carry infectious diseases, unlike those found in the bone marrow. This means that stem cells from the cord blood are less likely to be rejected when used for treatment.

Some of the health conditions that the cord blood can help in treating include tumors, cancer, immune deficiencies and disorders, genetic diseases, and blood disorders. Particularly, the stem cells in cord blood can help treat anemia, lymphoma, leukemia, diabetes, cerebral palsy, autism, and the like. With these numerous health benefits, it is no wonder that expectant parents now want to store their newborns cord blood. This means that storing the cord blood for future use might be worth it.

Handling Cord Blood

In todays medical setup, parents have the option of discarding, donating, or storing their newborns cord blood. Whatever the decision made, there is no right or wrong one. On the one hand, if the parents agree to discard their childs umbilical cord and everything that accompanies it, then thats fine. On the other hand, they can also decide to store the childs cord blood in a private cord blood bank.

Storage involves fees, of course. But the advantage of storing it is that the parents can request access to it later if needed. The parents can also decide to donate their childs cord blood to public cord blood banks for future patients or medical research.

There are two methods of cord blood banking. They are:

You can decide to store your childs cord blood in a commercial cord blood bank for later use by your child or other family members. Storing in private cord blood banks can be expensive, especially at the initial stage. Whether youre storing just the cord blood or the cord blood and tissues, expect nothing less than between USD$500 and USD$2,500 for the initial processing charges. In addition, youd still have to pay an annual storage renewal fee of somewhere between USD$100 and USD$300.

Some specialists believe that spending thousands of dollars to store cord blood in a private bank isnt worth it. This is because theres a slim probability that the child who owns the cord blood will need it. First, the child might not have a condition that warrants the use of the blood. Besides, if the child has a health condition that requires stem cell treatment, its most likely that the stem cells in the cord blood would contain the same genetic defects that are now causing the health problem. This means that the child cant make use of the cord blood.

However, it doesnt necessarily mean that it becomes useless. In case other siblings had their cord blood stored as well, the afflicted child can use theirs instead because theres a higher chance that their blood would match. Also, other complications that accompany having a third-party blood donor would be out of the way.

Unlike private cord banks, you wont be charged any fee for storage in a public cord blood bank. Theres no need for any payment because instead of the blood being stored for your personal use, the cord blood is being donated to the bank.

The beauty of this choice is that the cord blood is made available to individuals who need it. Most people prefer this option than storing for personal use since no financial commitment is involved. Moreover, if you or your family members later need cord blood, you could get cord blood donations as well.

Conclusion

Just like there are two sides to a coin, the decision whether storing your childs cord blood is worth it or not is dependent on diverse factors, most of which are beyond your control. Before choosing to discard, store, or donate your childs cord blood, try to consult your doctor first. Your doctor will guide you on how to handle the cord blood. Otherwise, if you dont have any problem with the financial commitments, then having umbilical cord blood when it is needed is definitely worth it!

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Umbilical cord blood banking: Is it worth it? - mtltimes.ca

Bone Marrow Stem Cells Comments Off on Umbilical cord blood banking: Is it worth it? – mtltimes.ca | August 18th, 2020

- PDUFA action date of February 15, 2021 assigned by U.S. Food and Drug Administration- Priority Review for trilaciclib is based on positive data from three randomized clinical trials showing robust myelopreservation benefits- G1 launching expanded access program (EAP) for patients with small cell lung cancer in the U.S.

RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes.

There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur, said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.

The FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.The trilaciclib NDA was supported by compelling myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with SCLC. Trilaciclibhas been granted Breakthrough Therapy Designation by the FDA.In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting to discuss this application.

While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations, said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center,University of North Carolina Chapel Hill, NC. Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.

Myelosuppression is the result of damage to bone marrow stem cells and is one of the most common side effects of chemotherapy. Myelosuppression can lead to serious conditions such as anemia, neutropenia or thrombocytopenia, which have broad ranging clinical, patient experience and economic impacts on ongoing cancer treatment and overall outcomes. In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Expanded Access ProgramG1 is making trilaciclib available to SCLC patients in the U.S., who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while the trilaciclib NDA is under regulatory review, pursuant to FDAs expanded access program (EAP). To facilitate needed access through the EAP, G1 is collaborating with Bionical Emas, a global specialist clinical research organization (CRO). For more information about the EAP access to trilaciclib, email patient.access.us@Bionical-emas.com.

Complications from myelosuppression have been a long-standing challenge when treating patients with SCLC, said Dr. Malik. Establishing an expanded access program provides qualified patients in serious need with access to trilaciclib while the NDA is under review.

Trilaciclib in Small Cell Lung CancerTrilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. In 2019, trilaciclib received FDA Breakthrough Therapy Designation, and, in June 2020, G1 submitted the NDA based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with small cell lung cancer (SCLC). In August 2020, G1 received FDA Priority Review with the Prescription Drug User Fee Act (PDUFA) date of February 15, 2021.

In June 2020, G1 announced a co-promotion agreement with Boehringer Ingelheim for trilaciclib in small cell lung cancer in the U.S. and Puerto Rico. If approved, G1 will lead marketing, market access and medical engagement initiatives for trilaciclib. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives.G1 will book revenue and retain development and commercialization rights to trilaciclib and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/ Boehringer Ingelheim agreement can be found here.

Evaluating Trilaciclib in Other CancersIn a randomized trial of women with metastatic triple-negative breast cancer, preliminary data showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to present final overall survival data from this trial in the fourth quarter of 2020. Trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL, and the company expects to initiate a Phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.

About G1 TherapeuticsG1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies: trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy; rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. In 2020, the company out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclibs possibility to improve patient outcomes across multiple indications, rintodestrants potential to be best-in-class oral SERD, lerociclibs differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Investors:Jeff MacdonaldG1 Therapeutics, Inc.Senior Director, Investor Relations & Corporate Communications919-907-1944jmacdonald@g1therapeutics.comMedia:Christine RogersG1 Therapeutics, Inc.Associate Director, Corporate Communications984-365-2819crogers@g1therapeutics.com

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G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer - GlobeNewswire

Bone Marrow Stem Cells Comments Off on G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer – GlobeNewswire | August 18th, 2020

In a surgical procedure last month, neurosurgeons from Kyoto University implanted 2.4 million cells into the brain of a patient with Parkinsons disease. The cellsderived from peripheral blood cells of an anonymous donorhad been reprogrammed into induced pluripotent stem cells (iPSCs) and then into dopaminergic precursor cells, which researchers hope will boost dopamine levels and ameliorate the patients symptoms.

The procedure is the most recent attempt by clinicians to test whether iPSCs can treat disease. In recent years, Japanese scientists have launched several clinical studies to examine their efficacy in heart disease and macular degeneration of the eye. And other researchers around the globe are exploring ways to turn the cells into treatments for everything from endometriosis to spinal cord injury. The initial foray into clinical trials raises hopes that the technology will bear fruit 12 years after its Nobel Prizewinning discovery.

Im excited that theyre trying to move it to the clinical level, because the iPS field does at some point need to start demonstrating that [these cells] have regenerative potential, says Jalees Rehman of the University of Illinois at Chicago. But the move towards clinical work is also revealing the difficulties of developing therapies. Its a learning curve, he adds.

So far, only a handful of patients have undergone iPSC-based treatments. In 2014, a woman with macular degeneration of the eye received a transplant of iPSC-based retinal cells derived from her own cells. The woman treated showed no apparent improvement in her vision, but the safety of the iPSC-derived cells was confirmed, writes Jun Takahashi, a stem cell biologist at Kyoto University who helped derive the dopaminergic precursor cells implanted into the Parkinsons disease patient. It was his wife, Masayo Takahashi of the RIKEN Center for Developmental Biology, who created the retinal cells used in that trial.

Last year, five patients were treated for the same eye condition with iPSC-derived retinal cells, which were taken from different donors. One of them patients developed a serious, but non-lifethreatening, reaction to the transplant, forcing doctors to remove it, according to the Japan Times.

More clinical studies are underway: Next year, heart surgeons plan to implant sheets of iPSC-derived cardiomyocytes into the hearts of three patients with heart disease, and Takahashi hopes to treat six more patients with Parkinsons disease by 2022. These are all in the earliest phases of testing. It is too early to say something [about the cells efficacy] in our trial, he adds.

While some researchers are waiting for the results of clinical studies to determine whether iPSCs have regenerative potential, others are racing ahead with preclinical studies presenting ever more ways on how to use them therapeutically. For instance, April Pyle, a stem cell biologist at the University of California, Los Angeles, recently developed an approach she believes is promising in treating Duchenne muscular dystrophy, a devastating disease caused by a mutation in the gene encoding the muscle-strengthening protein dystrophin. She and her colleagues used CRISPR-Cas9 to repair the gene in human iPSCs, turned them into skeletal muscle cells, and injected them into the muscle of dystrophin-deficient mice. We [could] actually see that weve restored dystrophin in pockets of the muscle, she explains.

I think its really just the beginning, she says. I think that were finally seeing the payoff for all of the hard work . . . and there will be many more trials to follow from these initial studies.

By now, researchers have figured out how to coax iPSCs to grow into most known cell types, Rehman says. But to get these cells to take on the roles of mature cells in a new tissue environment is another issue. In the heart, for instance, researchers have found that new stem cells have to be electrically aligned with the other cells. Experiments on human iPSC-derived heart muscle cells in culture show that by subjecting them to electrically induced contractions as they develop, the cells mature faster, suggesting that they become more able to handle the adult workload in vivo. How to integrate the new cells so they will survive in injured or diseased tissue is another question. Do you need a special matrix, a gel, a patch, an organoid, to ensure the success of these cells long term? Rehman asks. These challenges are faced in all the organs.

Researchers have been relying on monkey models to evaluate the efficacy of engraftment procedures before testing them in human patients, explains Takahashi. Last year, his team demonstrated on monkeys that human iPSCderived dopaminergic neurons stably integrated into existing brain tissue, where they produced dopamine and ultimately improved Parkinsonian symptoms.

The closer we get to [clinical] applications, the more we obviously realize the challenges that lie ahead.

Jalees Rehman, University of Illinois at Chicago

Another challenge with the implantation of iPSC-derived tissue is the ever-present risk that the cells might trigger cancer, because they stem from a cell type that is by nature highly proliferative. To avoid this, Takahashi and his colleagues filter the implanted cells to eliminate undifferentiated ones that are most prone to overgrowth, and also test the cell lines for tumorgenicity by implanting a sample into mice.

Still, we cannot completely eliminate the possibility of tumor formation, notes Tetsuo Maruyama, an associate professor of obstetrics and gynecology from Keio University School of Medicine. He thinks that such procedures should focus on non-essential organs, such as the eye or the uterus, for instance. He recently succeeded in deriving healthy uterine cells from iPSCs and plans to use these to study how endometriosis occurs, and also to generate human endometrium that could eventually be used clinically.

Another concern researchers have frequently raised are the immunosuppressive drugs that patients require if the iPSCs are derived from cells other than the patients own. Takahashis patient with Parkinsons, for instance, will be on immunosuppressants for a year, possibly making the patient less able to fight off infections and cancer. But despite the risks, many researchers have opted to use allogeneic stem cellsthose from a donorforemost because the approach will save time, cost, and labor when the time comes to scale up such treatments for commercialization. It is important when you think about industrialization, Takahashi writes in an email.

The possibility to create off the shelf iPSC therapies has also attracted industry, not just academics. For instance, Australia-based biotech company Cynata Therapeutics recently concluded a Phase I trial using iPSC-derived mesenchymal stem cells to treat graft-versus-host disease (GVHD). The condition occurs after bone marrow transplants when immune cells of the donor recognize cells in the recipients body as foreign and attack them, often resulting in death. But mesenchymal stem cells, which can mature into a variety of cell types, suppress the proliferation and activation of the donors T cells, explains Kilian Kelly, the companys vice president for product development. The company produced these cells by starting from iPSCs, reprogramming them in to an intermediary cell called a mesenchymoangioblast, and then directing them to become mesenchymal cells.

The trial, which the company claims is the worlds first to use iPSCs, administered the cells intravenously to 15 patients with GVHD who had previously failed to respond to steroid treatment and as such faced a grim prognosis. Although its too soon to evaluate efficacy, Kelly says, he sees it as a positive sign that 14 of them showed a notable improvement in their condition. And conveniently, immune rejection isnt an issue with mesenchymal stem cells because they dont express the donor-specific antigens that trigger rejection. So that means that we can use cells from a single iPS [cell] bank to treat essentially anybody, says Kelly.

Developing off-the-shelf treatments is also vastly more cost effective than maturing iPSC-derived cells for individual patients, adds Ross McDonald, the companys CEO. He points to personalized T-cell immunotherapiestwo of which have been recently FDA-approvedwhich can nearly$500,000 per patient. Its too soon to predict how much his product might cost, he adds.

This is one reason why several groups are developing banks of iPSCs that can be used to develop regenerative therapies at scale. For instance, the Japanese government decided to put around $250 million towards developing an iPSC stock for biomedical research. The donors from whom these cells are derived were carefully selected with immune compatibility in mind: the bank is designed to encompass a diverse set of commonly present human leukocyte antigen (HLA) types, so that they are broadly representative of the majority of the population. Then, implantation will require only a minimum amount of immune suppression. This is kind of a middle ground between using patient-specific cells and cells chosen at random, explains Amanda Mack, director of iPSC reprogramming at Fujifilm Cellular Dynamics, a Wisconsin-based company that grows human cells for biomedical research.

Together, the cells will be immunocompatible with almost 70 percent of the Japanese population, says Maruyama. This might be more difficult for countries such as the US, where the genetic makeup is more diverse, but similar efforts are also underway there. For instance, Macks company aims to develop a bank of iPSCs that are matched to a majority of the US population.

While efforts like these continue, researchers around the world are still figuring out the nuts and bolts of applying these cells therapeutically. The closer we get to [clinical] applications, the more we obviously realize the challenges that lie ahead, says Rehman. I think thats a very normal process for scientific discovery.

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Increasing Number of iPS Cell Therapies Tested in Clinical ...

IPS Cell Therapy Comments Off on Increasing Number of iPS Cell Therapies Tested in Clinical … | August 17th, 2020

Damaged cartilage can be treated through a technique called microfracture, in which tiny holes are drilled in the surface of a joint. The microfracture technique prompts the body to create new tissue in the joint, but the new tissue is not much like cartilage.

Microfracture results in what is called fibrocartilage, which is really more like scar tissue than natural cartilage, said Chan. It covers the bone and is better than nothing, but it doesnt have the bounce and elasticity of natural cartilage, and it tends to degrade relatively quickly.

The most recent research arose, in part, through the work of surgeon Matthew Murphy, PhD, a visiting researcher at Stanford who is now at the University of Manchester. I never felt anyone really understood how microfracture really worked, Murphy said. I realized the only way to understand the process was to look at what stem cells are doing after microfracture. Murphy is the lead author on the paper. Chan and Longaker are co-senior authors.

For a long time, Chan said, people assumed that adult cartilage did not regenerate after injury because the tissue did not have many skeletal stem cells that could be activated. Working in a mouse model, the team documented that microfracture did activate skeletal stem cells. Left to their own devices, however, those activated skeletal stem cells regenerated fibrocartilage in the joint.

But what if the healing process after microfracture could be steered toward development of cartilage and away from fibrocartilage? The researchers knew that as bone develops, cells must first go through a cartilage stage before turning into bone. They had the idea that they might encourage the skeletal stem cells in the joint to start along a path toward becoming bone, but stop the process at the cartilage stage.

The researchers used a powerful molecule called bone morphogenetic protein 2 (BMP2) to initiate bone formation after microfracture, but then stopped the process midway with a molecule that blocked another signaling molecule important in bone formation, called vascular endothelial growth factor (VEGF).

What we ended up with was cartilage that is made of the same sort of cells as natural cartilage with comparable mechanical properties, unlike the fibrocartilage that we usually get, Chan said. It also restored mobility to osteoarthritic mice and significantly reduced their pain.

As a proof of principle that this might also work in humans, the researchers transferred human tissue into mice that were bred to not reject the tissue, and were able to show that human skeletal stem cells could be steered toward bone development but stopped at the cartilage stage.

The next stage of research is to conduct similar experiments in larger animals before starting human clinical trials. Murphy points out that because of the difficulty in working with very small mouse joints, there might be some improvements to the system they could make as they move into relatively larger joints.

The first human clinical trials might be for people who have arthritis in their fingers and toes. We might start with small joints, and if that works we would move up to larger joints like knees, Murphy says. Right now, one of the most common surgeries for arthritis in the fingers is to have the bone at the base of the thumb taken out. In such cases we might try this to save the joint, and if it doesnt work we just take out the bone as we would have anyway. Theres a big potential for improvement, and the downside is that we would be back to where we were before.

Longaker points out that one advantage of their discovery is that the main components of a potential therapy are approved as safe and effective by the FDA. BMP2 has already been approved for helping bone heal, and VEGF inhibitors are already used as anti-cancer therapies, Longaker said. This would help speed the approval of any therapy we develop.

Joint replacement surgery has revolutionized how doctors treat arthritis and is very common: By age 80, 1 in 10 people will have a hip replacement and 1 in 20 will have a knee replaced. But such joint replacement is extremely invasive, has a limited lifespan and is performed only after arthritis hits and patients endure lasting pain. The researchers say they can envision a time when people are able to avoid getting arthritis in the first place by rejuvenating their cartilage in their joints before it is badly degraded.

One idea is to follow a Jiffy Lube model of cartilage replenishment, Longaker said. You dont wait for damage to accumulate you go in periodically and use this technique to boost your articular cartilage before you have a problem.

Longaker is the Deane P. and Louise Mitchell Professor in the School of Medicine and co-director of the Institute for Stem Cell Biology and Regenerative Medicine. Chan is a member of the Institute for Stem Cell Biology and Regenerative Medicine and Stanford Immunology.

Other Stanford scientist taking part in the research were professor of pathology Irving Weissman, MD, the Virginia and D. K. Ludwig Professor in Clinical Investigation in Cancer Research; professor of surgery Stuart B. Goodman, MD, the Robert L. and Mary Ellenburg Professor in Surgery; associate professor of orthopaedic surgery Fan Yang, PhD; professor of surgery Derrick C. Wan, MD; instructor in orthopaedic surgery Xinming Tong, PhD; postdoctoral research fellow Thomas H. Ambrosi, PhD; visiting postdoctoral scholar Liming Zhao, MD; life science research professionals Lauren S. Koepke and Holly Steininger; MD/PhD student Gunsagar S. Gulati, PhD; graduate student Malachia Y. Hoover; former student Owen Marecic; former medical student Yuting Wang, MD; and scanning probe microscopy laboratory manager Marcin P. Walkiewicz, PhD.

The research was supported by the National Institutes of Health (grants R00AG049958, R01 DE027323, R56 DE025597, R01 DE026730, R01 DE021683, R21 DE024230, U01HL099776, U24DE026914, R21 DE019274, NIGMS K08GM109105, NIH R01GM123069 and NIH1R01AR071379), the California Institute for Regenerative Medicine, the Oak Foundation, the Pitch Johnson Fund, the Gunn/Olivier Research Fund, the Stinehart/Reed Foundation, The Siebel Foundation, the Howard Hughes Medical Institute, the German Research Foundation, the PSRF National Endowment, National Center for Research Resources, the Prostate Cancer Research Foundation, the American Federation of Aging Research and the Arthritis National Research Foundation.

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Researchers find method to regrow cartilage in the joints - Stanford Medical Center Report

Bone Marrow Stem Cells Comments Off on Researchers find method to regrow cartilage in the joints – Stanford Medical Center Report | August 17th, 2020

HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years

VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company gives full update on all of its HIV programs.

HIV CureThe HIV co-receptor CCR5 has proven to be a key molecule in mediating HIV remission. The only two individuals functionally cured of HIV, one from London and the other from Berlin, received allogeneic stem cell transplantations from CCR5-deficient donors. However, because it is extremely rare to find a stem cell donor who lacks CCR5 and meets stringent MHC matching criteria, such an approach is unfeasible to cure HIV on a larger scale. CytoDyn believes its CCR5 blocking antibody, leronlimab, could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV.

CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure.

HIV PrEPAs presented at the AIDS 2020 Virtual Conference, a pre-clinical study in the macaque model of HIV sexual transmission demonstrated leronlimab can prevent infection by blocking HIVs access to the CCR5 co-receptor. This protection is similar to that seen in individuals naturally CCR5 deficient and forms the rationale for use in HIV cure. CytoDyn believes leronlimab could be a once-a-month self-injectable, subcutaneous treatment for HIV PrEP and is in discussions with potential organizations to fund its next trial in HIV PrEP.

MonotherapySignificantly, for the first time documented, of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trial for two to four years and five patients for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg. The number of participants in the extension groups was limited due to costs.

The Company will submit manuscripts for two publications in regards to its findings.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We now have four paths forward for use of leronlimab in the HIV indication for different populations. The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment. Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients HIV functional cure.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.

The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA to discuss the FDAs request for additional information in order to resubmit its Biologics License Application for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors:Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

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CytoDyn Will Attempt to Duplicate Berlin and London Patients' HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also...

Bone Marrow Stem Cells Comments Off on CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also… | August 17th, 2020

DUBLIN, Aug. 17, 2020 /PRNewswire/ -- The "Global Autologous Cell Therapy Market: Growth, Trends and Forecasts (2020-2025)" report has been added to ResearchAndMarkets.com's offering.

The Global Autologous Cell Therapy market is anticipated to grow at a CAGR of 15.9% during the forecast period.

The major factors attributing to the growth of the autologous cell therapy market are the rising incidence of chronic diseases such as autoimmune diseases, cancer, blood disorder, and others.

A rise in the population suffering from chronic diseases is also propelling the demand for market growth. In 2018, as per the AARDA (American Autoimmune Related Diseases Association) statistics, around 50 million Americans have an autoimmune disease, and this number is expected to rise in the future.

As per the CDC (Centers for Disease Control and Prevention) estimates Sickel Cell Disease (SCD) affects around 100,000 Americans annually - and there are few more factors which are playing crucial roles in taking the autologous cell therapy market to the next level, among them one is on-going drug developments for new applications which are expected to further propel the growth of the autologous cell therapy market.

Key Market Trends

Bone Marrow Segment Expected to Hold the Largest Market ShareBone marrow transplant is a technique for replacing damaged and destroyed cells with new stem cells in the bone marrow. Bone marrow is the most commonly used for autologous cell therapy as it can benefit individuals with a range of cancer (malignant) and non-cancer (benign) diseases and will drive the market during the forecast period.

As per the statistics from Globocan 2018, worldwide 18,078,957 individuals have cancer. Asia remains the leading contributor in the rising incidence of cancer with a reported share of 48.4% followed by Europe, North and Latin America, Africa, and Oceania with a share of 23.4%, 13.2% and 7.8%, 5.8%, and 1.4% respectively.

North America Dominates the Market and is Expected to do Same Over the Forecast Period

North America is expected to dominate the overall autologous cell therapy market, throughout the forecast period. This is owing to factors such as the rising incidence of chronic diseases such as cancer, blood disorder, autoimmune diseases, and other diseases and the availability of advanced healthcare infrastructure among the major factors.

In North America, the United States holds the largest market share owing to the factors such as increasing number of population suffering from cancer and other chronic diseases, along with the rising geriatric population and developments related to stem cell therapy and rising demand for biotechnological practices in the country, is anticipated to further drive the demand in this region.

Competitive Landscape

The autologous cell therapy market is moderately competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. And some prominent players are vigorously making acquisitions and joint ventures with the other companies to consolidate their market positions across the globe.

Some of the companies which are currently dominating the market are Vericel Corporation, Pharmicell Co. Inc., Holostem Terapie Avanzate S.r.l., Lineage Cell Therapeutics Inc., and Opexa Therapeutics.

Key Topics Covered

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Rising Incidence of Chronic Diseases4.2.2 Emphasis Increasingly on Drug Development for New Applications4.3 Market Restraints4.3.1 Systemic Immunological Reactions Possibility4.3.2 Expensive Practise, Product and High Capital Investment4.4 Porter's Five Force Analysis

5 MARKET SEGMENTATION5.1 By Therapy5.1.1 Autologous Stem Cell Therapy5.1.2 Autologous Cellular Immunotherapies5.2 By Application5.2.1 Oncology5.2.2 Musculoskeletal Disorder5.2.3 Blood Disorder5.2.4 Autoimmune Disease5.2.5 Others5.3 By Source5.3.1 Bone Marrow5.3.2 Epidermis5.3.3 Others5.4 By End User5.4.1 Hospitals5.4.2 Research Centers5.4.3 Others5.5 Geography5.5.1 North America5.5.2 Europe5.5.3 Asia-Pacific5.5.4 Middle-East and Africa5.5.5 South America

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Vericel Corporation6.1.2 Pharmicell Co. Inc.6.1.3 Holostem Terapie Avanzate S.r.l.6.1.4 Lineage Cell Therapeutics, Inc.6.1.5 Opexa Therapeutics6.1.6 BrainStorm Cell Therapeutics6.1.7 Sangamo Therapeutics

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information about this report visit https://www.researchandmarkets.com/r/22argo

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Global Autologous Cell Therapy Market Outlook to 2025 by Therapy, Application, Source, End User and Geography - Yahoo Finance

Bone Marrow Stem Cells Comments Off on Global Autologous Cell Therapy Market Outlook to 2025 by Therapy, Application, Source, End User and Geography – Yahoo Finance | August 17th, 2020

An uncles poignant and loving tribute to his niece after she died following a seven-year battle with Hodgkin Lymphoma has led to life-saving stem cell and bone marrow donations.

Dr Melissa Baker, a single mum of two and forensic pathologist from Melbourne, died on January 16 - just two days after her 45th birthday.

In her memory, Melissas beloved uncle Max Tomlinson placed her photo and information about how to become a stem cell donor on his rear window in the hope of carrying on her hard work.

In memory of my beautiful niece Dr Melissa Baker. You can save a life, dont let Melissas be in vain. Order your swab kit now. Ideally men aged 18 to 45 with diverse backgrounds needed urgently. Order your kit now urthecure.com.au, it reads in white marker pen.

Melissas beloved uncle, Max Tomlinson, placed her photo and information about how to become a stem cell donor on his car's rear window. Source: Facebook

Melissas sister, Jenni Baker, recently posted a picture of Mr Tomlinsons car on Facebook while thanking a member of the public who tucked a yellow flower under his windshield wiper.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work, Jenni, a Melbourne police officer, told Yahoo News Australia on Friday.

She underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection, her sister said.

Doctors told the 45-year-old, who had since developed cancer of the bone marrow as a result of the chemotherapy, she desperately needed a donor and so she began advocating for UR The Cure.

The volunteer-run charity works with the Australian Bone Marrow Donor Registry (ABMDR) to increase the number of donors especially middle-aged people of diverse backgrounds.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work. Source: Facebook

Reluctantly, in November 2019, she underwent a more risky half-match stem cell transplant where I was her donor, Jenni said.

The odds werent great but she had no choice.

Tragically, after 58 days in the hospital, most of which she spent on a ventilator, Melissa died on January 16.

Jennis Facebook post about her uncles tribute has garnered more than 2,500 likes and hundreds of comments, many of which are people who said they had since signed up to be a stem cell donor.

I was a bone marrow donor for my dad. Unfortunately he passed just four months after the donation. I would do it again in a heartbeat for anyone who needed it, one woman wrote.

Beautiful! Tell your uncle I just ordered my kit! another said.

A woman named Amanda also commented, revealing she had been one of Melissas nurses.

I dont know if you remember me. I am one of the nurses who took care of your sister in the ICU. I always admired how much support Melissa had from you and your sister. Her life is definitely not in vain and the love she had from you all was so strong, she wrote.

Melissa Baker underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection. Source: Facebook

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Jenni said Melissa never thought in her wildest dreams this would happen and had at one point thought the cancer would be a battle she would have to fight throughout her life.

The 47-year-old police officer told Yahoo News Australia Melissa became upset when she was often told she had the good cancer because of Hodgkins higher success rate.

She was so mad about it she even made a blog called I Got the Good Cancer documenting her struggles and treatments.

And then everything bad that could have happened, happened, Jenni said.

Jenni (right) and Melissa (left) are pictured together in front of Parliament House. Source: Facebook

The mum-of-two spent last Christmas intubated and sedated in hospital but was able to squeeze her childrens hands when they came to visit.

When the tubes came out on Boxing Day, Melissa mumbled to Jenni, Im scared. This is really scary.

They were the last words Melissa said.

Just two days later Melissa was ventilated again until the tubes were removed on January 14 - her birthday - after deciding it was too cruel.

Fifty-two hours later she passed surrounded by her parents, siblings and children.

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Uncles incredible tribute to niece who died from the good cancer' - Yahoo News Australia

Bone Marrow Stem Cells Comments Off on Uncles incredible tribute to niece who died from the good cancer’ – Yahoo News Australia | August 17th, 2020

New Jersey, United States,- This detailed market research covers the growth potential of the Stem Cell Therapy Market, which can help stakeholders understand the key trends and prospects of the Stem Cell Therapy market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Stem Cell Therapy market.

The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Stem Cell Therapy market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Stem Cell Therapy Report:

Overview of the Global Stem Cell Therapy Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Stem Cell Therapy market forecast estimation

This Stem Cell Therapy report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Stem Cell Therapy market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Stem Cell Therapy market?

What is the expected growth rate of the Stem Cell Therapy market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Stem Cell Therapy market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

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Stem Cell Therapy Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 - Bulletin Line

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line | August 17th, 2020

Newswise HACKENSACK, N.J.,AUGUST 17, 2020 U.S. News & World Report has recognized John Theurer Cancer Center at Hackensack University Medical Center as the best cancer center in New Jersey. The recognition reflects the extraordinary strength of its comprehensive patient care, research and education programs.

In 2019, John Theurer Cancer Center became a member of the National Cancer Institute-approved Georgetown Lombardi Comprehensive Cancer Center Consortium, making the Cancer Center a member of one of just 16 cancer consortia based at the nation's most prestigious institutions. The NCI endorses such consortia to bring together accomplished institutionswith independently proven records of excellence to join forces in pursuit of the NCI's original mission: improving cancer outcomes through scientific discovery, reducing the impact of cancer on individuals and communities and diminishing cancer disparities, and developing the next generation of cancer scientists, clinicians and educators.

John Theurer Cancer Center is organized into 16 specialized divisions, each led by a recognized expert in the field. With a strong focus on clinical science and innovation, John Theurer Cancer Center investigators were directly involved in the development of more than 40 new anticancer agents approved by the U.S. Food and Drug Administration over the last three yearsparticularly for blood cancers such as leukemia, lymphoma, and multiple myeloma, as well as solid tumors through Phase I first-in-human clinical trials.

"Our multidisciplinary team cares for patients with cancers of every type and stage in a highly subspecialized environment," said Robert C. Garrett, FACHE, CEO, Hackensack Meridian Health. "Our commitment to cancer is reflective of our approach to everything we do: to provide the most advanced health care services based on the latest findings of medical research in a compassionate, culturally sensitive setting. It is an honor for us to be recognized as the top cancer center in our state."

"Our exceptional team is proud to be recognized as the top cancer program in New Jersey. The scope and depth of expertise, together with our focus on clinical science and innovation, are what make our Cancer Center a destination program, explained Andre Goy, M.D., M.S., chair and chief physician of John Theurer Cancer Center, Lymphoma Division chief, physician-in-chief of the Hackensack Meridian Health Oncology Care Transformation Service, and a renowned lymphoma expert who led the Cancer Center's participation in the pioneering ZUMA-2 study. "Understandably, every person who receives a diagnosis of cancer seeks the center with the most experience and the best innovation. This is why patients come to John Theurer Cancer Center. We take care of each patient in a compassionate and friendly environment, and that's what makes our patients smile.

A number of metrics support that successful track record:

This recognition as the state's best cancer center reflects the strength of our research, the dedication of our multidisciplinary team, and the expertise of our physicians," said Ihor Sawczuk, MD, FACS, Hackensack Meridian Health regional president, Northern Market and chief research officer. We are grateful to our patients who have trusted us with their care and who continually inspire us to provide the best possible experience.

For more information, please contact Katherine Emmanouilidis, Director, Communications & Public Relations, 551-996-3764.

About Hackensack Meridian Health Hackensack University Medical Center

Hackensack Meridian Health Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the countys first hospital, it is now part of the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care, which is comprised of 35,000 team members and more than 7,000 physicians. Hackensack University Medical Center is ranked #2 in New Jersey and #59 in the country in U.S. News & World Reports 2019-20 Best Hospital rankings and is ranked high-performing in the U.S. in colon cancer surgery,lung cancersurgery,COPD, heart failure, heart bypass surgery, aortic valve surgery,abdominal aortic aneurysm repair, knee replacement and hip replacement. Out of 4,500 hospitals evaluated, Hackensack is one of only 57 that received a top rating in all nine procedures and conditions. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades Americas 50 Best Hospitals Award for five or more years in a row. Beckers Hospital Review recognized Hackensack University Medical Center as one of the 100 Great Hospitals in America 2018. The medical center is one of the top 25 green hospitals in the country according to Practice Greenhealth, and received 28 Gold Seals of Approval by The Joint Commission more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet recognized hospital for nursing excellence; receiving its sixth consecutive designation in 2019. Hackensack University Medical Center has created an entire campus of award-winning care, including: John Theurer Cancer Center, a consortium member of the NCI-designated Georgetown Lombardi Comprehensive Cancer Center; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Womens and Childrens Pavilion, which houses the Joseph M. Sanzari Childrens Hospital and Donna A. Sanzari Womens Hospital, which was designed with The Deirdre Imus Environmental Health Center and listed on the Green Guides list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to THE NORTHERN TRUST PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Childrens Cancer Institute housed at the Joseph M. Sanzari Childrens Hospital. To learn more, visit http://www.HackensackUMC.org.

About John Theurer Cancer Center atHackensack University Medical Center

John Theurer Cancer Center at Hackensack University Medical Center is New Jerseys largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 16 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey.John Theurer Cancer Center is amember of the Georgetown Lombardi Comprehensive Cancer Center Consortium,one of just 16 NCI-approved cancer research consortiabased at the nations most prestigious institutions. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities.For additional information, please visitwww.jtcancercenter.org

ABOUTHACKENSACKMERIDIAN HEALTH

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two childrens hospitals - Joseph M. Sanzari Childrens Hospital in Hackensack, K. Hovnanian Childrens Hospital in Neptune; nine community hospitals Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital Carrier Clinic in Belle Mead; and two rehabilitation hospitals - JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 36,000 team members, and 7,000 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The networks notable distinctions include having four of its hospitals are among the top hospitals in New Jersey for 2020-21, according toU.S. News & World Report. Additionally, the health system has more top-ranked hospitals than any system in New Jersey. Childrens Health is again ranked a top provider of pediatric health care in the United States and earned top 50 rankings in the annual U.S. News 2020-21 Best Childrens Hospitals report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Beckers Healthcares 150 Top Places to Work in Healthcare/2019 list.

The Hackensack Meridian School of Medicine, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton. The Hackensack Meridian Center for Discovery and Innovation (CDI), housed in a fully renovated state-of-the-art facility, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions.

Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

To learn more, visit http://www.hackensackmeridianhealth.org.

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Hackensack University Medical Center Has the Best Cancer Center in New Jersey John Theurer Cancer Center recognized by U.S. News & World Report -...

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Notably, several of the new studies are finding these powerful responses in people who did not develop severe cases of Covid-19, Dr. Iyer added. Some researchers have worried that infections that take a smaller toll on the body are less memorable to the immune systems studious cells, which may prefer to invest their resources in more serious assaults. In some cases, the body could even jettison the viruses so quickly that it fails to catalog them. This paper suggests this is not true, Dr. Iyer said. You can still get durable immunity without suffering the consequences of infection.

Updated August 17, 2020

What has been observed in people who fought off mild cases of Covid-19 might not hold true for hospitalized patients, whose bodies struggle to marshal a balanced immune response to the virus, or those who were infected but had no symptoms at all. Research groups around the world are continuing to study the entire range of responses. But the vast majority of the cases are these mild infections, said Jason Netland, an immunologist at the University of Washington and an author on the paper under review at Nature. If those people are going to be protected, thats still good.

This new spate of studies could also further assuage fears about how and when the pandemic will end. On Friday, updated guidance released by the Centers for Disease Control and Prevention was misinterpreted by several news reports that suggested immunity against the coronavirus might last only a few months. Experts quickly responded, noting the dangers of propagating such statements and pointing to the wealth of evidence that people who previously had the virus are probably at least partly protected from reinfection for at least three months, if not much longer.

Considered with other recent reports, the new data reinforce the idea that, Yes, you do develop immunity to this virus, and good immunity to this virus, said Dr. Eun-Hyung Lee, an immunologist at Emory University who was not involved in the studies. Thats the message we want to get out there.

Some illnesses, like the flu, can plague populations repeatedly. But that is at least partly attributable to the high mutation rates of influenza viruses, which can quickly make the pathogens unrecognizable to the immune system. Coronaviruses, in contrast, tend to change their appearance less readily from year to year.

Still, much remains unknown. Although these studies hint at the potential for protectiveness, they do not demonstrate protection in action, said Cheong-Hee Chang, an immunologist at the University of Michigan who was not involved in the new studies. Its hard to predict whats going to happen, Dr. Chang said. Humans are so heterogeneous. There are so many factors coming into play.

Research in animals could help fill a few gaps. Small studies have shown that one bout of the coronavirus seems to protect rhesus macaques from contracting it again.

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Scientists See Signs of Lasting Immunity to Covid-19, Even After Mild Infections - The New York Times

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For many patients with multiple myeloma, a new generation of drugs and drug combinations is producing better outcomes and fewer side effects. In recent months, several novel therapies studied and tested by Dana-Farber scientists have gained approval from the U.S. Food and Drug Administration (FDA) or taken a step toward approval after posting solid results in clinical trials.

The drugs are the fruit of years of research into improving treatment for multiple myeloma, a cancer of white blood cells known as plasma cells in the bone marrow. Many of the new agents are biologically derived made from substances such as proteins and antibodies found in living things and target biological mechanisms in a very specific, targeted fashion. Dana-Farber researchers have played a key role in these efforts.

These are each powerful examples of how next-generation novel therapies translated here at Dana-Farber from bench to bedside are further improving outcomes for our patients, and at a remarkable pace, says Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber.

Option for relapsed or refractory (non-responsive) myeloma

Following a Dana-Farber-led clinical trial, the FDA recently approved the novel drug isatuximab in combination with pomalidomide and dexamethasone for adults with relapsed or refractory (non-responsive) myeloma who have received at least two prior therapies, including lenalidomide and drugs known as proteasome inhibitors. The drug went into trials after laboratory work by Dana-Farbers Yu-Tzu Tai, PhD, and Kenneth Anderson, MD, showed it was active against myeloma cells. In the clinical trial, the three-drug combination lowered the risk that the disease would progress by 40%, compared to pomalidome and dexamethasone alone.

A drug that doesnt cause hair loss

Dana-Farber investigators conducted laboratory research and led the first clinical trial of the drug melflufen plus dexamethasone in patients with relapsed or refractory myeloma. Melflufen is a peptide conjugate drug made of a stub of protein, or peptide, joined to a chemotherapy agent and delivers a toxic payload directly to myeloma cells in a selective, time-sparing approach.

Results from an early-phase clinical trial published in Lancet Oncology showed the drug is active in patients with myeloma and is safe at recommended doses. Unlike the previously used standard drug melphalan, it doesnt cause mucositis inflammation of membranes within the digestive tract or hair loss. The results prompted investigators to launch two larger trials, some of whose results are being processed and are due to be published soon.

Drug for patients eligible for stem cell transplant

In a major study published in Blood, Dana-Farber researchers and their associates found that in patients newly diagnosed with myeloma who are eligible for a stem cell transplant, adding the drug daratumumab to the standard three-drug regimen produced more responses, and deeper responses, than in patients receiving the three-drug therapy alone.

Targeting myeloma cells and cell division

Dana-Farber researchers were involved in the development and initial testing of the drug belantamab mafodotin, which has shown considerable promise in clinical trials and has been granted priority review for approval by the FDA.

An antibody conjugate drug consisting of an antibody that specifically targets myeloma cells and an agent that disrupts cell division, its use was informed by a preclinical trial at Dana-Farber involving Yu-Tzu Tai, PhD, and Kenneth Anderson, MD. Balantamab mafodotin was tested in studies led by Paul Richardson, MD, in patients with relapsed or refractory multiple myeloma whose disease continued to worsen after a stem cell transplant, chemotherapy, or other treatment. In the DREAMM-1 and -2 trials, the drug showed strong anti-myeloma activity with manageable side effects.

This article was originally published on August 4, 2020, by Dana-Farber Cancer Institute. It is republished with permission.

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Wave of New Therapies Improve Outcomes for Patients with Multiple Myeloma - Cancer Health Treatment News

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As the on-going COVID-19 pandemic continues we are facing a huge healthcare crisis. Globally the pandemic has accelerated or rather decelerated the entire human population into the confines. Work from home, social shielding and discreet outdoor ventures has not only disrupted our emotional well-being but has also drastically affected our physical health. As people are confined to their homes with reduced physical activity there is rapid bone resorption (loss) as muscles and bones are not getting adequate stimulation. Also lack of exposure to sun during the pandemic has critically affected vitamin D levels in our body. People are frequently feeling tired with lack of energy and strength. Everyone needs to be cautious about the health of their bones as much as their other needs. Bones support us and allow us to be mobile. Bone health is always a priority and we always tend to overlook it. Bone density problem is a silent manifestation and could lead to a major medical issue over a period of time. While osteoporosis onsets with age among men & women, women face the brunt a little earlier, like from their 30s. Well-versed with the situation and to avoid unnecessary bones issues, let us now take a look at some measures that can take care of your bones during the pandemic.Eat a well-balanced diet rich in calcium and vitamin DGood sources of calcium include low-fat dairy products, green leafy veggies and dry fruits. Good sources of vitamin D include fortified cereals, egg yolks, saltwater fish, liver and milk. Calcium and vitamin D work together to protect your bones - calcium helps to build and maintain bones; while vitamin D helps your body to effectively absorb calcium.

Get exposure to sunlight to make enough vitamin DRegular sun exposure is the most natural way to get enough vitamin D. The sun's ultraviolet B (UVB) rays hit cholesterol in the skin cells, providing the energy for vitamin D synthesis. Vitamin D has a significant role in calcium homeostasis and metabolism.

As per pan-India study the best time to get exposed to the sun is between 11 am and 1 pm since the wavelength of ultraviolet B (UVB) rays is 290-320nm during this period which is essential for skin to make vitamin D.

Get plenty of physical activityLike muscles, bones become stronger with exercise. The best exercises for healthy bones are strength-building and weight-bearing exercise like walking, climbing stairs, lifting weights and dancing. Try to get 30 minutes of exercise each day.

Strength-building and weight-bearing exercise provides stimulation to bone cells and helps to increased bone mineral density and bone size thus reduced the risk of osteoporosis.

Live a healthy lifestyle

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What do we need to know about our bone health during this pandemic - Times of India

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