KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This approval is based on data from the Phase 2 KEYNOTE-629 trial, in which KEYTRUDA demonstrated meaningful efficacy and durability of response, with an objective response rate (ORR) of 34% (95% CI, 25-44), including a complete response rate of 4% and a partial response rate of 31%. Among responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median duration of response (DOR) had not been reached (range, 2.7 to 13.1+ months).

Cutaneous squamous cell carcinoma is the second most common form of skin cancer, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. In KEYNOTE-629, treatment with KEYTRUDA resulted in clinically meaningful and durable responses. Todays approval is great news for patients with cSCC and further demonstrates our commitment to bringing new treatment options to patients with advanced, difficult-to-treat cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

Data Supporting Approval

The efficacy of KEYTRUDA was investigated in patients with recurrent or metastatic cSCC enrolled in KEYNOTE-629 (NCT03284424), a multi-center, multi-cohort, non-randomized, open-label trial. The trial excluded patients with autoimmune disease or a medical condition that required immunosuppression. The major efficacy outcome measures were ORR and DOR as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

Among the 105 patients treated, 87% received one or more prior lines of therapy and 74% received prior radiation therapy. Forty-five percent of patients had locally recurrent only cSCC, 24% had metastatic only cSCC and 31% had both locally recurrent and metastatic cSCC. The study population characteristics were: median age of 72 years (range, 29 to 95); 71% age 65 or older; 76% male; 71% White; 25% race unknown; 34% Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 and 66% ECOG PS of 1.

KEYTRUDA demonstrated an ORR of 34% (95% CI, 25-44) with a complete response rate of 4% and a partial response rate of 31%. Among the 36 responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median DOR had not been reached (range, 2.7 to 13.1+ months).

Patients received KEYTRUDA 200 mg intravenously every three weeks until documented disease progression, unacceptable toxicity or a maximum of 24 months. Patients with initial radiographic disease progression could receive additional doses of KEYTRUDA during confirmation of progression unless disease progression was symptomatic, rapidly progressive, required urgent intervention, or occurred with a decline in performance status. Assessment of tumor status was performed every six weeks during the first year and every nine weeks during the second year.

Among the 105 patients with cSCC enrolled in KEYNOTE-629, the median duration of exposure to KEYTRUDA was 5.8 months (range, 1 day to 16.1 months). Patients with autoimmune disease or a medical condition that required systemic corticosteroids or other immunosuppressive medications were ineligible. Adverse reactions occurring in patients with cSCC were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer (NSCLC) treated with KEYTRUDA as a single agent. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence included lymphopenia (11%).

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 (MSI-H) 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.

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 Cancer

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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Researchers have known for quite some time that HD causes a progressive loss of neurons. But what if we could find a way to fill their place? In a new report, researchers used an intriguing strategy in living mice to do just that they converted a different type of brain cell into neurons, with very promising results.

In HD research we spend a lot of time talking about neurons. And understandably so! Neurons are the cell type in the brain most affected by HD, and they are the cells that exchange messages to drive our movements, moods, and memories. You can think of neurons like the computer programmers of the brain they convert information into action.

In particular, neurons in an area of the brain called the striatum striatal neurons tend to be most vulnerable to the mutation that causes HD. Right now no one knows exactly why those cells are especially vulnerable. But researchers know that many of the symptoms of HD are related to the loss of neurons in this area of the brain.

But there are lots of different types of cells in the brain. In fact, the most abundant cell type in the brain isnt neurons its a cell type called glia. Glia is a general term that describes several kinds of cells in the brain and spinal cord that provide support, insulation, and protection. You can think of glia like the body guard of the brain they make sure other cell types have the support they need to function.

One type of glia are brain cells called astrocytes. A lot of the nervous system is made up of astrocytes 30% in fact! Because astrocytes are everywhere in the brain, theyre also present in the areas where neurons degenerate due to HD the striatum. And unlike neurons that stop dividing when theyre fully mature, glia continue to divide.

Recently, scientists took advantage of the abundance of glia in the brain and their ability to reproduce. They used an experimental technique in the brains of mice to turn astrocytes into new, functioning neurons. So to stick with our analogy, they encouraged the body guards of the brain to change jobs and become computer programmers.

The work was led by Dr. Gong Chen, a former professor at Penn State University, who is now leading the Institute of CNS Regeneration at Jinan University in China. His team took advantage of a technique to turn cells that arent neurons into neurons something called direct conversion.

This technique allows researchers to coax different cell types, such as astrocytes, into becoming neurons, by adding chemical cocktails to boost the action of genes that influence a cells role. This is a bit like changing the job description of a certain cell type - but this has been done before. Many times in fact. Its old news that scientists can take one cell type grown in a laboratory dish and directly turn it into a neuron.

So what did this report add, and why was it worthy of publication in the prestigious journal Nature Communications? Because these authors did direct conversion inside the brains of living mice! They used a harmless virus to deliver their chemical cocktail that gave a genetic nudge to the astrocytes, encouraging them to change jobs and become neurons. In this way, they were able to turn abundant astrocytes into potentially valuable striatal neurons a very cool accomplishment!

We know what you may be thinking Did you just say virus?! We all get a little weary when we hear that word, especially in the days of COVID-19! But rest assured, this is a very harmless method used frequently in biology.

Its actually just the outside of the virus thats used, without any of the inside bits that typically make viruses so harmful. Similar to a letter in an envelope researchers here are repurposing an envelope and adding something new inside. So the old message is removed, and the envelope is sent with new instructions that body guards should change jobs and become computer programmers!

An important finding from the paper was that the overall number of astrocytes didnt decrease over time. This is related to the point we made above about astrocytes they continue to divide. So even though the researchers turned some of the astrocytes into neurons, the astrocytes that remained produced more astrocytes to replace them. This approach provided a source of new striatal neurons for these HD mice without affecting the astrocyte population! And because these astrocytes are already located in the striatum, the intervention occurs in the exact area of the brain that could use more neurons.

Chen and colleagues also showed that these new neurons in the striatum fired signals just like native neurons. They also connected with other areas of the brain, just like native neurons. Most compellingly, with the addition of these new neurons in the striatum, the HD mice performed better on movement tests and had an extended lifespan. All very exciting and promising results!

The idea of adding back lost neurons in HD isnt new. The big difference is that previous studies have added new cells through surgery, performing whats called cell transplantation. So while direct conversions, like the experiments performed by Chen and his team, are like changing jobs within the same company, cell transplantations are like getting a job at a new company.

Several research groups have experimented with cell transplantation as a therapy for HD, and some of these options are moving toward clinical trials. More recently, cell transplantations have been done with immature cells known as stem cells or neural progenitor cells that havent fully committed to becoming a specific cell type yet. The benefit of using immature cells is that they can obtain cues from the surrounding environment, letting them know what cell type is needed.

Cell transplantations have shown promise, but can come with some risks. Theres no guarantee that the cells will become exactly the type of neuron you want. And theres no guarantee that the cells will survive long-term because thats not their native environment.

Chens group got around these issues by triggering specific biological machinery to convert astrocytes into striatal neurons. The researchers knew exactly what type of neuron they were going to get in the end. And because the astrocytes they targeted were already present in the striatum, they knew the new neurons would be in exactly the right place!

One thing to keep in mind with this approach is that the astrocytes used to make the neurons come from the HD mouse. That means the new striatal neurons also contain the genetic error (mutation) that causes HD. Researchers dont yet know what that means for the lifespan of those neurons.

While the results from this study are very exciting and potentially provide another tool in our belt to combat HD, this study was done as a proof-of-concept and still has a long way to go before it reaches the clinic. But so far, even though the new neurons carry the HD mutation, the direct conversion technique seems to improve HD-related symptoms in the mice.

Follow up studies are likely to try this technique in larger animals or to test it in combination with huntingtin lowering, which will undoubtedly provide interesting results. Well be eagerly waiting!

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Changing jobs: converting other cell types into neurons - HDBuzz

Spinal Cord Stem Cells Comments Off on Changing jobs: converting other cell types into neurons – HDBuzz | June 24th, 2020

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues andtumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successfulstem cell therapytreatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

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Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market In-Depth Analysis and Forecast 2017-2025 - Daily Veterans

Spinal Cord Stem Cells Comments Off on Stem Cell Assay Market In-Depth Analysis and Forecast 2017-2025 – Daily Veterans | June 24th, 2020

The Autologous Stem Cell Based Therapies Market globally is a standout amongst the most emergent and astoundingly approved sectors. This worldwide market has been developing at a higher pace with the development of imaginative frameworks and a developing end-client tendency.

Autologous Stem Cell Based Therapies market reports deliver insight and expert analysis into key consumer trends and behaviour in marketplace, in addition to an overview of the market data and key brands. Autologous Stem Cell Based Therapies market reports provides all data with easily digestible information to guide every businessmans future innovation and move business forward.

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The worldwide Autologous Stem Cell Based Therapies market is an enlarging field for top market players,

The key players covered in this studyRegeneusMesoblastPluristem Therapeutics IncU.S. STEM CELL, INC.Brainstorm Cell TherapeuticsTigenixMed cell Europe

Market segment by Type, the product can be split intoEmbryonic Stem CellResident Cardiac Stem CellsUmbilical Cord Blood Stem Cells

Market segment by Application, split intoNeurodegenerative DisordersAutoimmune DiseasesCardiovascular Diseases

Market segment by Regions/Countries, this report coversUnited StatesEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Autologous Stem Cell Based Therapies status, future forecast, growth opportunity, key market and key players.To present the Autologous Stem Cell Based Therapies development in United States, Europe and China.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by product type, market and key regions.

In this study, the years considered to estimate the market size of Autologous Stem Cell Based Therapies are as follows:History Year: 2014-2018Base Year: 2018Estimated Year: 2019Forecast Year 2019 to 2025For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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This Autologous Stem Cell Based Therapies report begins with a basic overview of the market. The analysis highlights the opportunity and Autologous Stem Cell Based Therapies industry trends that are impacted the market that is global. Players around various regions and analysis of each industry dimensions are covered under this report. The analysis also contains a crucial Autologous Stem Cell Based Therapies insight regarding the things which are driving and affecting the earnings of the market. The Autologous Stem Cell Based Therapies report comprises sections together side landscape which clarifies actions such as venture and acquisitions and mergers.

The Report offers SWOT examination and venture return investigation, and other aspects such as the principle locale, economic situations with benefit, generation, request, limit, supply, and market development rate and figure.

Quantifiable data:-

Geographically, this report studies the top producers and consumers, focuses on product capacity, production, value, consumption, market share and growth opportunity in these key regions, covering North America, Europe, China, Japan, Southeast Asia, India

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Research objectives and Reason to procure this report:-

Finally, the global Autologous Stem Cell Based Therapies market provides a total research decision and also sector feasibility of investment in new projects will be assessed. Autologous Stem Cell Based Therapies industry is a source of means and guidance for organizations and individuals interested in their market earnings.

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Insight on the Growth of Autologous Stem Cell Based Therapies Market Growth with Challenges, Standardization, Competitive Market Share and Top Players...

Cardiac Stem Cells Comments Off on Insight on the Growth of Autologous Stem Cell Based Therapies Market Growth with Challenges, Standardization, Competitive Market Share and Top Players… | June 24th, 2020

LOS ANGELES, United States: QY Research has recently published a report, titled Global Autologous Stem Cell Based Therapies Market Size, Status and Forecast 2020-2026. The market research report is a brilliant, complete, and much-needed resource for companies, stakeholders, and investors interested in the global Autologous Stem Cell Based Therapies market. It informs readers about key trends and opportunities in the global Autologous Stem Cell Based Therapies market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global Autologous Stem Cell Based Therapies market.

Key companies operating in the global Autologous Stem Cell Based Therapies market include , Regeneus, Mesoblast, Pluristem Therapeutics Inc, US STEM CELL, INC., Brainstorm Cell Therapeutics, Tigenix, Med cell Europe, Autologous Stem Cell Based Therapies

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Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Autologous Stem Cell Based Therapies market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Autologous Stem Cell Based Therapies Market Segment By Type:

, Embryonic Stem Cell, Resident Cardiac Stem Cells, Umbilical Cord Blood Stem Cells Autologous Stem Cell Based Therapies

Global Autologous Stem Cell Based Therapies Market Segment By Application:

, Neurodegenerative Disorders, Autoimmune Diseases, Cardiovascular Diseases

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Autologous Stem Cell Based Therapies market.

Key companies operating in the global Autologous Stem Cell Based Therapies market include , Regeneus, Mesoblast, Pluristem Therapeutics Inc, US STEM CELL, INC., Brainstorm Cell Therapeutics, Tigenix, Med cell Europe, Autologous Stem Cell Based Therapies

Key questions answered in the report:

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TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Autologous Stem Cell Based Therapies Revenue1.4 Market by Type1.4.1 Global Autologous Stem Cell Based Therapies Market Size Growth Rate by Type: 2020 VS 20261.4.2 Embryonic Stem Cell1.4.3 Resident Cardiac Stem Cells1.4.4 Umbilical Cord Blood Stem Cells1.5 Market by Application1.5.1 Global Autologous Stem Cell Based Therapies Market Share by Application: 2020 VS 20261.5.2 Neurodegenerative Disorders1.5.3 Autoimmune Diseases1.5.4 Cardiovascular Diseases1.6 Study Objectives1.7 Years Considered 2 Global Growth Trends2.1 Global Autologous Stem Cell Based Therapies Market Perspective (2015-2026)2.2 Global Autologous Stem Cell Based Therapies Growth Trends by Regions2.2.1 Autologous Stem Cell Based Therapies Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Autologous Stem Cell Based Therapies Historic Market Share by Regions (2015-2020)2.2.3 Autologous Stem Cell Based Therapies Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Autologous Stem Cell Based Therapies Market Growth Strategy2.3.6 Primary Interviews with Key Autologous Stem Cell Based Therapies Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Autologous Stem Cell Based Therapies Players by Market Size3.1.1 Global Top Autologous Stem Cell Based Therapies Players by Revenue (2015-2020)3.1.2 Global Autologous Stem Cell Based Therapies Revenue Market Share by Players (2015-2020)3.1.3 Global Autologous Stem Cell Based Therapies Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Autologous Stem Cell Based Therapies Market Concentration Ratio3.2.1 Global Autologous Stem Cell Based Therapies Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Autologous Stem Cell Based Therapies Revenue in 20193.3 Autologous Stem Cell Based Therapies Key Players Head office and Area Served3.4 Key Players Autologous Stem Cell Based Therapies Product Solution and Service3.5 Date of Enter into Autologous Stem Cell Based Therapies Market3.6 Mergers & Acquisitions, Expansion Plans 4 Market Size by Type (2015-2026)4.1 Global Autologous Stem Cell Based Therapies Historic Market Size by Type (2015-2020)4.2 Global Autologous Stem Cell Based Therapies Forecasted Market Size by Type (2021-2026) 5 Market Size by Application (2015-2026)5.1 Global Autologous Stem Cell Based Therapies Market Size by Application (2015-2020)5.2 Global Autologous Stem Cell Based Therapies Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Autologous Stem Cell Based Therapies Market Size (2015-2020)6.2 Autologous Stem Cell Based Therapies Key Players in North America (2019-2020)6.3 North America Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)6.4 North America Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 7 Europe7.1 Europe Autologous Stem Cell Based Therapies Market Size (2015-2020)7.2 Autologous Stem Cell Based Therapies Key Players in Europe (2019-2020)7.3 Europe Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)7.4 Europe Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 8 China8.1 China Autologous Stem Cell Based Therapies Market Size (2015-2020)8.2 Autologous Stem Cell Based Therapies Key Players in China (2019-2020)8.3 China Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)8.4 China Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 9 Japan9.1 Japan Autologous Stem Cell Based Therapies Market Size (2015-2020)9.2 Autologous Stem Cell Based Therapies Key Players in Japan (2019-2020)9.3 Japan Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)9.4 Japan Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Autologous Stem Cell Based Therapies Market Size (2015-2020)10.2 Autologous Stem Cell Based Therapies Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)10.4 Southeast Asia Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 11 India11.1 India Autologous Stem Cell Based Therapies Market Size (2015-2020)11.2 Autologous Stem Cell Based Therapies Key Players in India (2019-2020)11.3 India Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)11.4 India Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Autologous Stem Cell Based Therapies Market Size (2015-2020)12.2 Autologous Stem Cell Based Therapies Key Players in Central & South America (2019-2020)12.3 Central & South America Autologous Stem Cell Based Therapies Market Size by Type (2015-2020)12.4 Central & South America Autologous Stem Cell Based Therapies Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Regeneus13.1.1 Regeneus Company Details13.1.2 Regeneus Business Overview13.1.3 Regeneus Autologous Stem Cell Based Therapies Introduction13.1.4 Regeneus Revenue in Autologous Stem Cell Based Therapies Business (2015-2020))13.1.5 Regeneus Recent Development13.2 Mesoblast13.2.1 Mesoblast Company Details13.2.2 Mesoblast Business Overview13.2.3 Mesoblast Autologous Stem Cell Based Therapies Introduction13.2.4 Mesoblast Revenue in Autologous Stem Cell Based Therapies Business (2015-2020)13.2.5 Mesoblast Recent Development13.3 Pluristem Therapeutics Inc13.3.1 Pluristem Therapeutics Inc Company Details13.3.2 Pluristem Therapeutics Inc Business Overview13.3.3 Pluristem Therapeutics Inc Autologous Stem Cell Based Therapies Introduction13.3.4 Pluristem Therapeutics Inc Revenue in Autologous Stem Cell Based Therapies Business (2015-2020)13.3.5 Pluristem Therapeutics Inc Recent Development13.4 US STEM CELL, INC.13.4.1 US STEM CELL, INC. Company Details13.4.2 US STEM CELL, INC. Business Overview13.4.3 US STEM CELL, INC. Autologous Stem Cell Based Therapies Introduction13.4.4 US STEM CELL, INC. Revenue in Autologous Stem Cell Based Therapies Business (2015-2020)13.4.5 US STEM CELL, INC. Recent Development13.5 Brainstorm Cell Therapeutics13.5.1 Brainstorm Cell Therapeutics Company Details13.5.2 Brainstorm Cell Therapeutics Business Overview13.5.3 Brainstorm Cell Therapeutics Autologous Stem Cell Based Therapies Introduction13.5.4 Brainstorm Cell Therapeutics Revenue in Autologous Stem Cell Based Therapies Business (2015-2020)13.5.5 Brainstorm Cell Therapeutics Recent Development13.6 Tigenix13.6.1 Tigenix Company Details13.6.2 Tigenix Business Overview13.6.3 Tigenix Autologous Stem Cell Based Therapies Introduction13.6.4 Tigenix Revenue in Autologous Stem Cell Based Therapies Business (2015-2020)13.6.5 Tigenix Recent Development13.7 Med cell Europe13.7.1 Med cell Europe Company Details13.7.2 Med cell Europe Business Overview13.7.3 Med cell Europe Autologous Stem Cell Based Therapies Introduction13.7.4 Med cell Europe Revenue in Autologous Stem Cell Based Therapies Business (2015-2020)13.7.5 Med cell Europe Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Trending: Autologous Stem Cell Based Therapies 2020: Global Size, Supply-Demand, Product Type and End User Analysis To 2026 - Weekly Wall

Cardiac Stem Cells Comments Off on Trending: Autologous Stem Cell Based Therapies 2020: Global Size, Supply-Demand, Product Type and End User Analysis To 2026 – Weekly Wall | June 24th, 2020

The world is increasingly becoming aware of the various kinds of damages that the SARS-CoV-2 can cause. However, researchers from Virginia Tech have found that the relatively harmless Adenovirus can cause heart conditions, which can be as life-threatening as the one induced by COVID-19.

According to the first-of-its-kind study, adenovirus can hamper the electrical signaling pathways between cells in the heart and also impair the ability of the cell to make new communication channels. The scientists exposed heart cells to the virus and learned of the potent effects it had on them.

"This is the first time we're putting this human virus on human heart cells to see what it does in the context of infected heart muscle cells. That's the real power of this," James Smyth, lead author of the study, said.

Adenoviruses belong to a class of common viruses that cause infections in the lining of the lungs, eyes, nervous system, and urinary tract. They often give rise to coughs, fever, pink eye, and sore throats, among others. While it generally affects children, all are prone to it.

The communication between heart muscles takes place through channels called gap junctions. They are formed by proteins known as connexins. Creating a bridge between two cells, gap junctions leads to the sharing of electrical signals that aid in the rhythmic contraction of the heart muscle cells. However, gap junctions can also alert neighboring cells about viral attacks.

Through the study, the researchers intended to demonstrate that the virus hijacks gap junctions, and when it does, it can decrease the production of connexin43(a component of a gap function). This in turn interrupts the electrical system that enables regular functioning of the heart, leading to arrhythmias (irregular heartbeat), and in extreme cases, cardiac death.

The researchers designed a diagnostic technique that employed pluripotent stem cell derived-cardiomyocytes, which are skin cells that have been made to convert to heart cells. The adenovirus was then applied to the cardiomyocytes and the resulting interactions were observed.

As expected, the virus hijacked the gap junctions in order to facilitate its own replication. However, the scientists also observed something that they had not anticipated. It was noted that two distinct processes were being carried out by the virus and that it inflicted dual damage to the cell's capacity to communicate with their neighbors. "Firstly, it was rapidly closing existing channels, and secondly it was shutting down the cells' ability to make new ones," explained Patrick Calhoun, co-author of the study.

Another aspect that caught the eye of the authors was the manner in which the virus prevented the creation of connexin43 and the formation of gap junctions. A protein pathway that is conventionally associated with the making of fresh connexin, was instead made to suppress its production by the virus. "We might learn something very new about the molecular biology there that's causing that switch," Smyth said

Smyth admits that the research is bound by the limitations of extending the results to a living heart while the experiment was conducted in vitro. However, highlighting the potential value of the findings, he asserted, "Fundamental studies provide the footing for the translational research that discovers therapeutics and diagnostic methods that improve people's health."

Going beyond the sheer understanding of viral infection, the research, Calhoun emphasized, can generate new therapeutic interventions for diseased hearts. "We're essentially learning from adenovirus to find the most efficient ways to stop, rather than cause, arrhythmias," he stressed.

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Scientists Find This Relatively Harmless Virus Can Attack and Damage Human Heart - International Business Times, Singapore Edition

Cardiac Stem Cells Comments Off on Scientists Find This Relatively Harmless Virus Can Attack and Damage Human Heart – International Business Times, Singapore Edition | June 24th, 2020

Bone marrowaspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

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The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.Europe and North America spearheaded the market as of 2016, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

In 2016, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others

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Bone Marrow Processing Systems Market Insights on Challenges & Opportunities by 2025 - 3rd Watch News

Bone Marrow Stem Cells Comments Off on Bone Marrow Processing Systems Market Insights on Challenges & Opportunities by 2025 – 3rd Watch News | June 24th, 2020

The global Stem Cell Banking market was valued at USD 1.52 billion in 2016 and is projected to reach USD 7.94 billion by 2025, growing at a CAGR of 20.17% from 2017 to 2025.

View Source Of Related Reports:

Viral Inactivation MarketVirus Filtration MarketViral Clearance MarketVeterinary-Animal Vaccines Market Vaccine Adjuvants MarketTerahertz and Infrared Spectroscopy MarketTangential Flow Filtration MarketSterile Filtration MarketStem Cell Banking Market

Stem Cell banking involves preservation of new born placental stem cells or amniotic stem cells as well as adult bone marrow stem cells. The concept ensures health safety in case of a major surgery or organ regeneration needs for the patient. With increasing awareness regarding the practice, the market is expected to boost in near future.

The Final Report will cover the impact analysis of COVID-19 on this industry:

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Sample Infographics:

Market Dynamics:1. Market Drivers1.1 Easy Extraction Methods1.2 High birth ratio1.3 Increase in GDP and Disposable income in developing nations1.4 Increasing support from public and private sector1.5 Scope of stem cell usage in therapeutics and treatment2. Market Restraints2.1 Large number of players in the market2.2 High Cost of technology2.3 Lack of awareness2.4 Regulatory restrains

Market Segmentation:1. By Application:1.1 Cerebral Palsy1.2 Thalassemia1.3 Leukemia1.4 Diabetes1.5 Autism1.6 Others

2. By Services:2.1 Collection & Transportation2.2 Processing2.3 Analysis2.4 Storage

3. By Bank Type:3.1 Cord Blood3.2 Cord Tissue

4. By Region:4.1 North America (U.S., Canada, Mexico)4.2 Europe (Germany, UK, France, Rest of Europe)4.3 Asia Pacific (China, India, Japan, Rest of Asia Pacific)4.4 Latin America (Brazil, Argentina, Rest of Latin America)4.5 Middle East & Africa

Competitive Landscape:The major players in the market are as follows:1.CBR Systems, Inc.2. Cordlife3. Cryo-Cell4. Cryo-Save AG (A Group of Esperite)5. Lifecell6. Stemcyte7. Viacord8. Smart Cells International Ltd.9. Cryoviva India10. Cordvida11. China Cord Blood CorporationThese major players have adopted various organic as well as inorganic growth strategies such as mergers & acquisitions, new product launches, expansions, agreements, joint ventures, partnerships, and others to strengthen their position in this market.

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RESEARCH METHODOLOGY OF VERIFIED MARKET INTELLIGENCE:Research study on the Stem Cell Bankingmarketwas performed in five phases which include Secondary research, Primary research, subject matter expert advice, quality check and final review.The market data was analyzed and forecasted using market statistical and coherent models. Also market shares and key trends were taken into consideration while making the report. Apart from this, other data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, Top to Bottom Analysis and Vendor Share Analysis.

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Stem Cell Banking Market Report (2020-2025) | The Demand For The Market Will Drastically Increase In The Future - Jewish Life News

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market Report (2020-2025) | The Demand For The Market Will Drastically Increase In The Future – Jewish Life News | June 24th, 2020

Leukemia are a heterogeneous group of cancers affecting the bone marrow and White Blood Cells (WBC). Leukemia is characterized by the rapid increase of abnormal blood cells growth or blasts, resulting in a decrease in the numbers of healthy, normal fully modified blood cells, leading to the typical symptoms of bleeding, anemia, and high risk of infection. Leukemia can grow along either the myeloid or lymphoid stem cell lines, it depends on the effect of genetic and epigenetic mutations on the progression of pluripotent stem cells to the various lines of mature cells which then pass into the blood. The effected line, combined with the rate of action and growth of disease reflects the four types of leukemias- Acute Myeloid Leukemia (AML), chronic lymphoblastic leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia. AML: Acute Myeloid Leukemia, is a serious condition, its the most common leukemia suffered by adult people. According to a report from American Cancer Society, the average age for first diagnostic for AML is 64. With few days without treatment, AML develops fast, in duration of few weeks, the patient becomes severely ill. Due to its fast onset and acuteness in nature, there is no staging system for Acute Myeloid Leukemia (AML).The treatment for Acute Myeloid Leukemia (AML) has changed in last 4 decades.

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The drug approval process is difficult in AML, (many drugs have not been approved by USFDA, for instance Laromustine, Dacogen and Tipitarnib) efforts have been made to introduce new therapies in the AML market.

Primary drivers boosting the growth of acute myeloid leukemia (AML) therapeutics market are minimal but increased prevalence of acute myeloid leukemia (AML), increased drug approval rate for AML, classification of acute myeloid leukemia (AML) as an orphan disease. Over the forecast period, population of people over 65 year is anticipated to increase, which is another key driver for acute myeloid leukemia (AML) therapeutics market.

However, lack of targeted therapies in current acute myeloid leukemia (AML) therapeutics landscape, the drug difficult approval process in AML can hinder the growth of acute myeloid leukemia (AML) therapeutics market, but this restraint has opened an opportunity for key players to innovate acute myeloid leukemia (AML) therapeutics market.

The global acute myeloid leukemia (AML) therapeutics market is segmented on the basic of disease subtype, treatment type, end user and region.

Based on the disease subtype, the acute myeloid leukemia (AML) therapeutics market is segmented into the following:

Based on treatment type, the acute myeloid leukemia (AML) therapeutics market is segmented into the following:

Based on end user, the acute myeloid leukemia (AML) therapeutics market is segmented into the following:

The global acute myeloid leukemia (AML) therapeutics market is anticipated to show lucrative growth owing to increased investment in innovative technologies by key players. Players in this market using various strategies to fuel their global footprint and to gain a competitive edge. Product pipelines, new product launches, agreements and collaborations, acquisitions, mergers and clinical trials are some key strategies applied from global players in recent years are anticipated to give a robust hike to the market in the forecast period.

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Geographically, acute myeloid leukemia (AML) therapeutics market is segmented into regions viz. North America, Latin America, Europe, Asia Pacific and Japan, Middle East and Africa. North America is anticipated to be major contributor to this market accounting maximum percent of share in AML therapeutics market followed by Europe. Slow but constant growth in prevalence for AML in North America is anticipated to fuel the growth in acute myeloid leukemia (AML) therapeutics market. In Asia pacific region, China and India are anticipated to show high growth in acute myeloid leukemia (AML) therapeutics market due to new developments in healthcare infrastructure in the region.

The players in acute myeloid leukemia (AML) therapeutics market include Ambit Biosciences Corporation, Celgene Corporation, Cephalon Inc., Clavis Pharma ASA, Eisai Co. Ltd, Genzyme Corporation, and Sunesis Pharmaceuticals Inc., Abbvie Inc., Astellas Pharma Inc, CTI Biopharma Corp etc.

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Acute Myeloid Leukemia (AML) Therapeutics Market Promising Growth Opportunities over 2017 2025 - 3rd Watch News

Bone Marrow Stem Cells Comments Off on Acute Myeloid Leukemia (AML) Therapeutics Market Promising Growth Opportunities over 2017 2025 – 3rd Watch News | June 24th, 2020

The Maryland Stem Cell Research Commission (The Commission) recently announced over $7M in Maryland Stem Cell Fund (MSCF) grant awards for its second round of 2020 MSCF fund recipients. The MSCF, which is a program of the Maryland Technology Development Corporation (TEDCO), has awarded $157M in funding to BioHealth Capital Region (BHCR) companies seeking to accelerate stem cell research, therapies and commercialization of products since 2007.

The $7M in new funding follows MSCFs announcement in September 2019 of over $1.3M in grants for the first cohort of 2020 recipients, bringing the total 2020 MSCF award tally to approximately $8.3M for the year. The financial awards are delivered across a wide range of areas, including clinical, commercialization, validation, launch, discovery, and post-doctoral fellowships. The first cohort of funding included three commercialization and two validation awards; the second, larger recipient pool included one clinical, one commercialization, one validation, four launches, 11 discovery, and five post-doctoral awards.

Notable BHCR MSCF recipients included:

Dr. Luis Garza of Johns Hopkins University (JHU) received a clinical grant to support clinical trials for his autologous volar fibroblast injection into the stump site of amputees. The trials are exploring ways to make the skin where a prosthetic limb meets the stump site tougher and less irritable to the wearer. Skin irritation is a major issue for those with prosthetic limbs and is often a cause for individuals to stop wearing their prosthesis.

Vita Therapeutics, a company that spun out of JHU, was awarded a 300K MSCF grant to support the commercialization of the companys satellite stem cell therapy for limb-girdle Muscular Dystrophy. According to the National Organization for Rare Disorders (NORD), Limb-girdle muscular dystrophies (LGMD) are a group of rare progressive genetic disorders that are characterized by wasting (atrophy) and weakness of the voluntary muscles of the hip and shoulder areas (limb-girdle area). Vita Therapeutics is led by CEO Douglass Falk, who is a JHU alum.

Jamie Niland, VP of Baltimore, Marylands Neoprogen Inc. received part of $892,080K in funding that was part of MSCFs first 2020 grant round. Jamie is the son of Bill Niland, Neoprogens current CEO and the former leader of Baltimore, Maryland life science community anchor Harpoon Medical, which was acquired by Edwards Scientific in 2017. The award was for Neoprogens neonatal cardiac stem cells for the heart tissue regeneration program.

Dr. Brian Pollok of Rockville, Marylands Propagenix, Inc., was also the recipient of a commercialization award for his Apical Surface-Outward (ASO) airway organoids, which is a potential novel cell system for drug discovery and personalized medicine. Propagenix develops innovative new technologies that address unmet needs in epithelial cell biologyfor applications in life science research as well as in precision diagnostics, and next-generation therapeutics such as immune-oncology, tissue engineering, and regenerative medicine, according to the companys website.

In addition, Dr. Ines Silva, R&D Manager of REPROCELL, USA received an MSCF commercialization grant for its work on building a commercial neural cell bank from patient-derived induced pluripotent stem cells. REPROCELL was founded in Japan in 2003 and acquired BioServe in Beltsville, Maryland in 2014.

Dr. Sashank Reddy, the founder of JHU startup LifeSprout and Medical Director, Johns Hopkins Technology Ventures Johns Hopkins University, received a portion of the $1,334,462 distributed for launch grants in 2020. The grant will go to support the launch of regenerative cell therapies for soft tissue restoration. LifeSprout recently closed a $28.5M seed round.

Past MSCF grant recipients include Frederick, Marylands RoosterBio, Inc. and Theradaptive, Inc., and Baltimore, Marylands Gemstone Biotherapeutics and Domicell, Inc., among others.

TEDCOs MSRF program continues to lend its deep support and ample funding to build and grow Marylands burgeoning and exciting regenerative medicine industry. Well be keeping a close eye on these companies as they grow and make future contributions to the thriving BHCR biocluster.

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

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Over $8M in 2020 Stem Cell Funding Awards Continue to Fuel Marylands Leading Cell Therapy Industry - BioBuzz

Skin Stem Cells Comments Off on Over $8M in 2020 Stem Cell Funding Awards Continue to Fuel Marylands Leading Cell Therapy Industry – BioBuzz | June 24th, 2020

The unwanted side effects include blisters, scabbing, hyperpigmentation, and hypopigmentation. Of some comfort: Pigmentation issues aren't always permanent. If you get it, let your doctor know right away and use a little cortisone 1% cream on the area, says Marmur. Keep it out of the sun and heat, and apply a cool compress ASAP.

If you're predisposed to hyperpigmentation, your dermatologist may even make a preemptive strike. For patients with darker skin types, we apply over-the-counter hydrocortisone 1% cream in the office to minimize inflammation and the risk of darkening of skin, or post-inflammatory hyperpigmentation," says Kim. "We recommend applying the cream twice daily to the affected areas for three to five days.

It largely varies, since the lasers themselves have gotten better over the years. I've had patients who were able to tolerate the treatment without any numbing, and patients who experienced some pain even with topical anesthesia, says Kim. (I, a baby, prefer to spend an hour with numbing cream and have never felt a thing.)

Marmur compares the laser beam to a zinging feeling, similar to a needle prick. She's a fan of contact cooling systems, as they blunt the heat created as the laser beam (which is light energy) converts into heat. Plus, they offer enough cooling to minimize any damage caused to surrounding skin, reducing the risk of hyperpigmentation.

Certain pain-reducing methods, like suctions and contact cooling, are often built into the lasers. There is a new laser by Lumenis called Splendor that is very effective and significantly more comfortable than other existing lasers, and I have had great success with it, says Kim. Because this laser is much more comfortable, I have been able to treat almost all patients without any topical numbing cream which significantly reduces the waiting time for the patients as well.

Since laser hair removal heats up your skin as it blasts your hair follicles, it's important to cool it back down afterwards to avoid side effects like redness. We often give people cold gauze in Ziploc bags, says Marmur. If you're getting in a car, put on the air conditioning and stay in a cool place for a bit, or take a cool shower afterwards.

Marmur sends her patients home with a cooling serum, the Marmur Metamorphosis MMRevive Serum. You could also try Avne Cicalfate Restorative Protective Cream, which soothes with a combination of barrier-repairing ingredients and probiotics.

Avoiding sun exposure and wearing sunscreen is also a must, as sunlight can kickstart hyperpigmentation. Kim recommends wearing a minimum of SPF 30. Got another session coming up? Patients should not wax, pluck, or thread the treated areas in between treatments, because it's essential for the hair follicles to be intact in order for the treatments to be effective at the next session," he says.

If we're being technical, laser hair removal is something of a misnomer. It's more like laser hair reduction, says Marmur. That's because you have two types of hair: vellus hairs, which are fine baby hairs, and terminal hairs, which are more coarse. The vellus baby hairs get affected by hormones and convert to terminal hairs throughout your life, she says.

So, you may do laser hair removal at 18, but by 30, you might have new growth coming in. It's just nature doing its thing. That being said, once a hair follicle root is dead, it's dead forever.

Always make sure you're going to a board certified dermatologist or reputable practitionerthis isn't a procedure you want to cut corners on just because you found a good discount online. And don't be afraid to ask for a consultation ahead of an appointment to discuss the procedure. As for during your appointment, you'll want to make sure both you and your practitioner have safety goggles on while the laser is in process.

At-home laser hair removal devices also exist, but they're generally less effective (meaning it will take much longer to see results), and theres more room for error as the beam is less specific. This is why experts generally suggest going in-office for the procedure.

Laser hair removal costs an average of $285 for one session, according to the latest stats from the American Society of Plastic Surgeons, but some treatments can run up to $1,500 per session. That's because the cost varies widely according to a number of factors, such as the size of the area you're treating, the provider's expertise, and where you're located. Just remember: Any treatment that seems too affordable to be true, often is.

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Is Laser Hair Removal Worth the Cost & Hassle? What to Know - Glamour

Skin Stem Cells Comments Off on Is Laser Hair Removal Worth the Cost & Hassle? What to Know – Glamour | June 24th, 2020

Introduction

Breastfeeding is the cornerstone of infant and young child survival, nutrition and development and maternal health. The World Health Organization recommends exclusive breastfeeding for the first 6 months of life, followed by continued breastfeeding with appropriate complementary foods for up to 2 years and beyond.1 Early and uninterrupted skin-to-skin contact, rooming-in2 and kangaroo mother care3 also significantly improve neonatal survival and reduce morbidity and are recommended by WHO.

However, concerns have been raised about whether mothers with COVID-19 can transmit the SARS-CoV-2 virus to their infant or young child through breastfeeding. Recommendations on mother-infant contact and breastfeeding must be based on a full consideration of not only of the potential risks of COVID-19 infection of the infant, but also the risks of morbidity and mortality associated with not breastfeeding, the inappropriate use of infant formula milks, as well as the protective effects of skin-to-skin contact. This scientific brief examines the evidence to date on the risks of transmission of COVID-19 from an infected mother to her baby through breastfeeding as well as evidence on the risks to child health from not breastfeeding.

WHO recommends that mothers with suspected or confirmed COVID-19 should be encouraged to initiate or continue to breastfeed. Mothers should be counselled that the benefits of breastfeeding substantially outweigh the potential risks for transmission.4

Mother and infant should be enabled to remain together while rooming-in throughout the day and night and to practice skin-to-skin contact, including kangaroo mother care, especially immediately after birth and during establishment of breastfeeding, whether they or their infants have suspected or confirmed COVID-19.

A living systematic review of evidence that followed the procedures of the Cochrane handbook for systematic reviews of interventions was carried out with the latest search done on 15 May 2020 to identify studies including mothers with suspected or confirmed COVID-19 and their infants or young children.5 The search was conducted on Cochrane Library, EMBASE (OVID), PubMed (MEDLINE), Web of Science Core Collection (Clarivate Analytics) and the WHO Global Database. A total of 12,198 records were retrieved, 6945 were screened after removing duplicates, and 153 records with mother-infant dyads in which the mother had COVID-19 were included in full-text review.

A total of 46 mother-infant dyads had breastmilk samples tested for COVID-19. All mothers had COVID-19, while 13 infants tested COVID-19 positive. Breastmilk samples from 43 mothers were negative for the COVID-19 virus while samples from 3 mothers tested positive for viral particles by RT-PCR. Among the 3 infants whose mothers breastmilk tested positive for virual RNA particles, not live virus, one infant tested positive for COVID-19 but infant feeding practices were not reported. The two other infants tested negative for COVID-19; one was breastfed, and the other newborn was fed expressed breast milk after viral RNA particles were no longer detected. In the single child with COVID-19, it was unclear through which route or source the infant became infected, i.e. through breastmilk or droplet from a close contact with the infected mother.

A preprint article reported secretory immunoglobulin A (sIgA) immune response against the COVID-19 virus found in 12 of 15 breastmilk samples from mothers with COVID-19.6 The implications of this finding on the effect, duration and protection against COVID-19 for the child was not addressed.

To date, studies of mother-infant dyads with data on feeding practices and COVID-19 infection have come from case reports, case series or a report of a family cluster. Other study designs such as cohort studies or case-control studies were eligible for inclusion, but none were identified. We are thus unable to measure and compare risks of infection based on feeding practices.

Although 1 of the 3 infants of mothers with viral particles in breast milk had COVID-19, it was unclear through which route or source the infant was infected, i.e., through breastfeeding or close contact with the mother or other infected person. RT-PCR detects and amplifies viral genetic material in samples, such as breastmilk, but does not provide information on viability or infectivity of the virus. Documented presence of replicative COVID-19 virus in cell culture from breast milk and infectivity in animal models are needed to consider breast milk as potentially infectious.

The presence of IgA in breast milk is one of the ways in which breastfeeding protects infants against infection and death. IgA antibodies with reactivity to the COVID-19 virus have been detected in breastmilk of mothers previously infected with COVID-19 but their strength and durability have not yet been adequately studied to address protection from COVID-19 among breastfed infants.

Detection of COVID-19 viral RNA in breastmilk is not the same as finding viable and infective virus. Transmission of COVID-19 would need replicative and infectious virus being able to reach target sites in the infant and also to overcome infant defense systems. If in the future COVID-19 virus from breastmilk were shown to be replicative in cell culture it would need to reach target sites in the infant and overcome infant defense systems for transmission of COVID-19 to occur.

The implications of transmission risk need to be framed in terms of COVID-19 prevalence in breastfeeding mothers and the scope and severity of COVID-19 infection in infants when transmission occurs compared to the adverse consequences of separation and using breastmilk substitutes and also separation of newborns and young infants from mothers.

Children appear to be at low risk of COVID-19. Among the cases of confirmed COVID-19 in children, most have experienced only mild or asymptomatic illness.7,8 This is also the case with other zoonotic coronaviruses (SARS-CoV and MERS-CoV), which seem to affect children less commonly and to cause fewer symptoms and less severe disease compared with adults.9

Secretory IgA have been detected in breastmilk of mothers with previous COVID-19 infection. Although the strength and durability of sIgA reactive to COVID-19 have not yet been determined, multiple bioactive components have been identified in breastmilk that not only protect against infections but improve neurocognitive and immunologic development of the child since Lars A Hanson first described sIgA in breastmilk in 1961.10-12

Skin-to-skin contact and kangaroo mother care facilitate breastfeeding as well as improve thermoregulation, blood glucose control, and maternal-infant attachment, and decrease the risk in mortality and severe infection among low birth weight infants.13,14 Beyond the neonatal period, positive effects of mother-infant holding include improved sleep patterns, lower rates of behavioural problems in the child and higher quality parental interaction.15,16

Exclusively breastfed infants, the risk of mortality is 14-fold higher in infants who are not breastfed.17 Over 820 000 childrens lives could be saved every year among children under 5 years, if all children 0-23 months were optimally breastfed. For mothers, breastfeeding protects against breast cancer and may protect against ovarian cancer and type 2 diabetes.18 On the other hand, children are at low risk of COVID-19.

It is still not clear whether the virus can or cannot be transmitted though breast milk. Risk of transmission based on feeding practices have not been quantified, compared, or modelled against the benefits of breastfeeding and nurturing mother-infant interaction.

At present, data are not sufficient to conclude vertical transmission of COVID-19 through breastfeeding. In infants, the risk of COVID-19 infection is low, the infection is typically mild or asymptomatic, while the consequences of not breastfeeding and separation between mother and child can be significant. At this point it appears that COVID-19 in infants and children represents a much lower threat to survival and health than other infections that breastfeeding is protective against. The benefits of breastfeeding and nurturing mother-infant interaction to prevent infection and promote health and development are especially important when health and other community services are themselves disrupted or limited. Adherence to infection prevention and control measures is essential to prevent contact transmission between COVID-19 suspected or confirmed mothers and their newborns and young infants.

Based on available evidence, WHO recommendations on the initiation and continued breastfeeding of infants and young children also apply to mothers with suspected or confirmed COVID-19.

WHO continues to monitor the situation closely for any changes that may affect this interim guidance. Should any factors change, WHO will issue a further update. Otherwise, this scientific brief will expire 2 years after the date of publication.

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Breastfeeding and COVID-19 - World Health Organization

Skin Stem Cells Comments Off on Breastfeeding and COVID-19 – World Health Organization | June 24th, 2020

Get a complete overview of the market trends, size, key market players, and scope with a new report on Skin Care Cosmetic Market added by Big Market Research.

The recent research report on the global Skin Care Cosmetic Market presents the latest industry data and future trends, allowing you to recognize the products and end users driving Revenue growth and profitability of the market.The report offers an extensive analysis of key drivers, leading market players, key segments, and regions. Besides this, the experts have deeply studied different geographical areas and presented a competitive scenario to assist new entrants, leading market players, and investors determine emerging economies. These insights offered in the report would benefit market players to formulate strategies for the future and gain a strong position in the global market.

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The report begins with a brief introduction and market overview of the Skin Care Cosmetic industry followed by its market scope and size. Next, the report provides an overview of market segmentation such as type, application, and region. The drivers, limitations, and opportunities for the market are also listed, along with current trends and policies in the industry.

The report provides a detailed study of the growth rate of every segment with the help of charts and tables. Furthermore, various regions related to the growth of the market are analyzed in the report. These regions include North America, Europe, Asia-Pacific, Latin America, Middle East & Africa. Besides this, the research demonstrates the growth trends and upcoming opportunities in every region.Analysts have revealed that the Skin Care Cosmetic market has shown several significant developments over the past few years. The report offers sound predictions on market value and volume that can be beneficial for the market players, investors, stakeholders, and new entrants to gain detailed insights and obtain a leading position in the market.Additionally, the report offers an in-depth analysis of key market players functioning in the global Skin Care Cosmetic industry.

Major market players are:The Estee Lauder Companies IncKao CorporationUnilever PLCLOreal S.A.Johnson & JohnsonAvon Products IncBeiersdorf AGProcter & GambleThe Body Shop International PLC

The research presents the performance of each player active in the global Skin Care Cosmetic market. It also offers a summary and highlights the current advancements of each player in the market. This piece of data is a great source of study material for the investors and stakeholders interested in the market. In addition, the report offers insights on suppliers, buyers, and merchants in the market. Along with this, a comprehensive analysis of consumption, market share, and growth rate of each application is offered for the historic period.

The end users/applications listed in the report are:Stem Cells Protection Against UVFlakiness ReductionRehydrate the Skin SurfaceMinimize wrinklesIncrease the viscosity of Aqueous

The key product type of Skin Care Cosmetic market are:Sensitive Skin CareDry Skin CareInfants Skin CareOthers

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The report clearly shows that the Skin Care Cosmetic industry has achieved remarkable progress since 2027 with numerous significant developments boosting the growth of the market. This report is prepared based on a detailed assessment of the industry by experts. To conclude, stakeholders, investors, product managers, marketing executives, and other experts in search of factual data on supply, demand, and future predictions would find the report valuable.

The report constitutes:Chapter 1 provides an overview of Skin Care Cosmetic market, containing global revenue, global production, sales, and CAGR. The forecast and analysis of Skin Care Cosmetic market by type, application, and region are also presented in this chapter.Chapter 2 is about the market landscape and major players. It provides competitive situation and market concentration status along with the basic information of these players.Chapter 3 provides a full-scale analysis of major players in Skin Care Cosmetic industry. The basic information, as well as the profiles, applications and specifications of products market performance along with Business Overview are offered.Chapter 4 gives a worldwide view of Skin Care Cosmetic market. It includes production, market share revenue, price, and the growth rate by type.Chapter 5 focuses on the application of Skin Care Cosmetic, by analyzing the consumption and its growth rate of each application.Chapter 6 is about production, consumption, export, and import of Skin Care Cosmetic in each region.Chapter 7 pays attention to the production, revenue, price and gross margin of Skin Care Cosmetic in markets of different regions. The analysis on production, revenue, price and gross margin of the global market is covered in this part.Chapter 8 concentrates on manufacturing analysis, including key raw material analysis, cost structure analysis and process analysis, making up a comprehensive analysis of manufacturing cost.Chapter 9 introduces the industrial chain of Skin Care Cosmetic. Industrial chain analysis, raw material sources and downstream buyers are analyzed in this chapter.Chapter 10 provides clear insights into market dynamics.Chapter 11 prospects the whole Skin Care Cosmetic market, including the global production and revenue forecast, regional forecast. It also foresees the Skin Care Cosmetic market by type and application.Chapter 12 concludes the research findings and refines all the highlights of the study.Chapter 13 introduces the research methodology and sources of research data for your understanding.

About Us:Big Market Research has a range of research reports from various publishers across the world. Our database of reports of various market categories and sub-categories would help to find the exact report you may be looking for.We are instrumental in providing quantitative and qualitative insights on your area of interest by bringing reports from various publishers at one place to save your time and money. A lot of organizations across the world are gaining profits and great benefits from information gained through reports sourced by us.

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Skin Care Cosmetic Market size is likely to register considerable growth rate in the coming years - Medic Insider

Skin Stem Cells Comments Off on Skin Care Cosmetic Market size is likely to register considerable growth rate in the coming years – Medic Insider | June 24th, 2020

The study on the Anti-Ageing Drugs Marketby Brand Essence Market Research is a compilation of systematic details in terms of market valuation, market size, revenue estimation, and geographical spectrum of the business vertical. The study also offers a precise analysis of the key challenges and growth prospects awaiting key players of the Anti-Ageing Drugs market, including a concise summary of their corporate strategies and competitive setting.

In 2018, the Global Anti-Ageing Drugs Market size was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2019-2025.

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The latest report pertaining to Anti-Ageing Drugs Market provides a detailed analysis regarding market size, revenue estimations and growth rate of the industry. In addition, the report illustrates the major obstacles and newest growth strategies adopted by leading manufacturers who are a part of the competitive landscape of this market.

Anti-aging drugs are used to slow down or reverse the processes of aging to extend the lifespan. Aging, is that damage to the bodys macromolecules, cells, tissues, which is facilitated by genomic instability, epigenetic alterations, loss of proteostasis, mitochondrial dysfunction, cellular senescence, stem cell exhaustion, oxidation damage by free radicals etc

In this report, 2018 has been considered as the base year and 2019 to 2025 as the forecast period to estimate the market size for Anti-Ageing Drugs.

This report studies the global market size of Anti-Ageing Drugs, especially focuses on the key regions like United States, European Union, China, and other regions (Japan, Korea, India and Southeast Asia).

This study presents the Anti-Ageing Drugs sales volume, revenue, market share and growth rate for each key company, and also covers the breakdown data (sales, revenue and market share) by regions, type and applications. history breakdown data from 2014 to 2019, and forecast to 2025.

For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2014 to 2019.

In global market, the following companies are covered: Nu Skin BIOTIME Elysium Health La Roche-Posay DermaFix

Market Segment by Product Type Hormonal Therapy Antioxidants Enzymes Stem Cells Others

Market Segment by Application Skin Hair Others

Anti-Ageing Drugs market report consists of the worlds crucial region market share, size (volume), trends including the product profit, price, value, production, capacity, capability utilization, supply, and demand. Besides, market growth rate, size, and forecasts at the global level have been provided. The geographic areas covered in this report:North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa).

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. Top-down and bottom-up approaches are used to validate the global market size market and estimate the market size for manufacturers, regions segments, product segments and applications (end users). All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or other factors are not accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from BrandEssenceResearch and presented in this report.

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation, extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub segments listed in this report. Extensive qualitative and further quantitative analysis is also done from all the numbers arrived at in the complete market engineering process to list key information throughout the report.

The study objectives are: To analyze and research the Anti-Ageing Drugs status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast. To present the key Anti-Ageing Drugs manufacturers, presenting the sales, revenue, market share, and recent development for key players. To split the breakdown data by regions, type, companies and applications To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks. To identify significant trends, drivers, influence factors in global and regions To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

In this study, the years considered to estimate the market size of Anti-Ageing Drugs are as follows: History Year: 2014-2018 Base Year: 2018 Estimated Year: 2019 Forecast Year 2019 to 2025

Table of Contents

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.4.1 Global Anti-Ageing Drugs Market Size Growth Rate by Type (2014-2025)1.4.2 Topical Products1.4.3 Botulinum1.4.4 Dermal Fillers1.4.5 Chemical Peels1.4.6 Microabrasion Equipment1.4.7 Laser Surfacing Treatments1.5 Market by Application1.5.1 Global Anti-Ageing Drugs Market Share by Application (2014-2025)1.5.2 Hospitals1.5.3 Dermatology Clinics1.6 Study Objectives1.7 Years Considered

2 Global Growth Trends2.1 Anti-Ageing Drugs Market Size2.2 Anti-Ageing Drugs Growth Trends by Regions2.2.1 Anti-Ageing Drugs Market Size by Regions (2014-2025)2.2.2 Anti-Ageing Drugs Market Share by Regions (2014-2019)2.3 Industry Trends2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Opportunities

3 Market Share by Key Players3.1 Anti-Ageing Drugs Market Size by Manufacturers3.1.1 Global Anti-Ageing Drugs Revenue by Manufacturers (2014-2019)3.1.2 Global Anti-Ageing Drugs Revenue Market Share by Manufacturers (2014-2019)3.1.3 Global Anti-Ageing Drugs Market Concentration Ratio (CR5 and HHI)3.2 Anti-Ageing Drugs Key Players Head office and Area Served3.3 Key Players Anti-Ageing Drugs Product/Solution/Service3.4 Date of Enter into Anti-Ageing Drugs Market3.5 Mergers & Acquisitions, Expansion Plans

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US Biotherapeutics Cell Line Market Insights and Forecast 2020 to 2025 - Cole of Duty

Skin Stem Cells Comments Off on US Biotherapeutics Cell Line Market Insights and Forecast 2020 to 2025 – Cole of Duty | June 24th, 2020

The global bioprinting market should reach $1.4 billion by 2024 from $306.2 million in 2019 at a compound annual growth rate (CAGR) of 35.4% for the period 2019 to 2024.

Report Scope:

This new BCC Research report on the topic Current Bioprinting Prospects and Future Innovations offers a detailed perspective on bioprinting technology, its current market and future prospects. The report provides a comprehensive analysis of the trending applications of bioprinting in the market in the global context, including market forecasts and sales through 2024. The report is focused on the analysis of the bioprinting market by various product types, regions and applications.

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The products that matter the most, i.e., instruments (bioprinters), reagents (bioinks), 3D cell culture products, and software and services, are discussed and analyzed. Each of these segments are sub-divided into different types (as detailed later). The emphasis is on the printing instruments, reagents, tissue products, skin substitutes, etc. The report also highlights the popular and emerging applications of bioprinting in the clinical and research domains. The end user markets, i.e., research and development, cosmetics, drug discovery, clinical and others, are analyzed in this report. Other end user markets include chemical, agrochemical, educational, hobbyist and veterinary applications. This study includes a survey of the bioprinting market in all geographic regions, including North America, Europe, and Emerging markets. The Emerging markets include regions like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America, among others.

The report elaborates on the critical issues and challenges facing the bioprinting industry as well as emerging trends in bioprinting technologies. It additionally features the new developments and new product launches in the global market.

The new BCC report provides relevant patent analysis and comprehensive profiles of market players in the industry. The industry structure chapter focuses on changing market trends, important manufacturers/suppliers, their market shares and product offerings. The chapter also covers mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that are expected to shape the industry.

Factors such as the strengths, weaknesses, threats and opportunities that are expected to play a role in the evolution of the bioprinting market are also evaluated. Any regulatory changes or new initiatives are highlighted explicitly.

Excluded from this report is medical 3D printing, which focuses on nonliving materials used in medical devices. Examples of medical devices that are not covered include treatment models, surgical tools and guides, prosthetics, dental restorations and crowns, and surgical implants.

Report Includes:

85 data tables and 27 additional tables Comprehensive analysis of the bioprinting technologies and their trending applications in the market at a global scale Analyses of the global market trends with data from 2017 to 2018, estimates for 2019, and projections of compound annual growth rates (CAGRs) through 2024 Segmentation of the global market by technologies and products, notably instruments (bioprinters), reagents (bioinks), 3D cell culture products, and software and services Focus on the popular and emerging applications of bioprinting in the clinical and research domains Regional dynamics of bioprinting technologies covering North America, Europe and Other emerging markets including India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America etc. Discussion of new developments and new product launches in the global bioprinting market A relevant patent analysis Company profiles of market players in the industry, including 3Dynamic Systems Ltd., Aspect Biosystems, GeSiM, n3D Biosciences Inc., Organovo Holdings Inc., Prellis Biologics Inc. and regenHU Ltd.

Summary

Bioprinting is a form of additive manufacturing technology, that can be used to fabricate biomimicking 3D tissue constructs and organs. The reliability and accuracy offered by these 3D tissue structures and organ constructs have made them highly attractive for a number of applications. The use of stem cells in bioprinting has significant prospects in the area of personalized medicine, to develop customized tissues/organs for repair or for the fabrication of personalized 3D tissue models for drug toxicity testing.

There is a huge unmet demand for organs. Bioprinting of 3D organs has the potential to reduce the endless wait lists of organ donations and revolutionize the medical industry. Though a number of studies are going on catering to the development of fully, functional organs by bioprinting, a number of challenges remain. These pertain to the fabrication of complex tissues with multiple cell types, the issue of resolution, and the incorporation of vascularization, among other factors.

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Despite these challenges, 3D bioprinting has undergone extensive progress and is used in many other applications. The 3D tissues being biofabricated can be used for tissue engineering and regenerative medicine. From the treatment of wounds (3D skin tissues), to craniomaxillofacial repair and orthopedic reconstructive surgeries (bone grafts), to the vascular grafts used to treat the growing number of heart disease patientsthese are just some of the potential clinical applications of bioprinting. In addition, in situ bioprinters that have the ability to treat the wounds/injuries by directly printing cells at a wound site are also gaining immense popularity.

One of the main drivers of the bioprinting market are the applications of 3D tissue constructs and biofabricated organ-on-chips for in vitro drug testing. The pharmaceutical industry is constrained by a high rate of drug failures at the clinical stage. Bioprinted 3D models reproduce natural tissues very closely and, therefore, are ideal materials for in vitro drug testing and other preclinical testing studies. The potential of 3D tissues to alleviate the burden on animal testing is another reason for their increased popularity. Poietis recently launched the biofabricated skin tissue, Poieskin, which can be used for cosmetic testing applications. Moreover, a multitude research organizations and universities aredeveloping 3D tissue models for disease modeling, drug research and cancer studies, among others.

The bioprinting market is propelled by innovations in bioprinting technologies and products encompassing bioprinters, bioinks, software, and 3D tissue products. The number of U.S. patents issued in 2018 (through November 4, 2018) in the field of bioprinting increased to 38, from a total of 27 in 2017. The highest number of patents were issued in the category of 3D cell culture products followed by the bioinks segment. Strategic collaborations and partnerships among research institutes and bioprinting companies along with interested partners from the pharmaceuticals and cosmetics sectors are supporting the growth of bioprinting market in a big way. Other factors driving the growth of the bioprinting market include increased government grants, the rising interest of private venture capitalists supporting several bioprinting start-ups, and the increasing healthcare burden.

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Bioprinting Market Insights on Scope the COVID-19 3w Market News Reports - 3rd Watch News

Skin Stem Cells Comments Off on Bioprinting Market Insights on Scope the COVID-19 3w Market News Reports – 3rd Watch News | June 24th, 2020

The concept of a vampire predates Bram Stokers tales of Count Dracula probably by several centuries. But did vampires ever really exist?

In 1819, 80 years before the publication of Dracula, John Polidori, an Anglo-Italian physician, published a novel called The Vampire. Stokers novel, however, became the benchmark for our descriptions of vampires. But how and where did this concept develop? It appears that the folklore surrounding the vampire phenomenon originated in that Balkan area where Stoker located his tale of Count Dracula.

Stoker never travelled to Transylvania or any other part of Eastern Europe. (The lands held by the fictional count would be in modern-day Romania and Hungary.)

The writer was born and brought up in Dublin. He was a friend to Oscar Wilde and William Gladstone. He was both a Liberal and a home-ruler in favour of home rule for Ireland. He turned to theatre, and became business manager of the Lyceum Theatre in London. It was his friendship with Armin Vambery, a Hungarian writer, that led to his fascination with vampire folklore. He consulted Vambery in the writing of Dracula, whose main character was loosely fashioned on Vlad the Impaler, a bloodthirsty prince born in Transylvania in 1431.

But where did the myth of vampires come from? Like many myths, it is based partly in fact. A blood disorder called porphyria, which has has been with us for millennia, became prevalent among the nobility and royalty of Eastern Europe. Porphyria is an inherited blood disorder that causes the body to produce less heme a critical component of hemoglobin, the protein in red blood cells that carries oxygen from the lungs to the body tissues. It seems likely that this disorder is the origin of the vampire myth. In fact, porphyria is sometimes referred to as the vampyre disease.

Consider the symptoms of patients with porphyria:

Sensitivity to sunlight: Extreme sensitivity to sunlight, leading to facial disfigurement, blackened skin and hair growth.

Fangs: In addition to facial disfigurement, repeated attacks of the disease causes the gums to recede, exposing the teeth, which then look like fangs.

Blood drinking: Because the urine of persons with porphyria is dark red, folklore surmised that they were drinking blood. In fact, some physicians had recommended that these patients drink blood to compensate for the defect in their red blood cells but this recommendation was for animal blood. It is more likely that these patients, who only went out after dark, were judged to be looking for blood, and their fangs led to folk tales about vampires.

Aversion to garlic: The sulfur content of garlic could lead to an attack of porphyria, leading to very acute pain. Thus, the aversion to garlic.

Reflections not seen in mirrors: In the mythology, a vampire is not able to look in a mirror, or cannot see its reflection. The facial disfigurement caused by porphyria becomes worse with time. Poor oxygenation leads to destruction of facial tissues, and collapse of the facial structure. Patients understandably avoided mirrors.

Fear of the crucifix: During the Spanish Inquisition (1478-1834), 600 vampires were reportedly burned at the stake. Some of these accused vampires were innocent sufferers of porphyria. Porphyria patients had good reason to fear the Christian faith and Christian symbols.

Acute attacks of the disease are associated with considerable pain, and both mental and physical disturbance. This condition has been ascribed to the English King George III, although subsequent analysis has shed some doubt on porphyria as the cause of his madness.

Nowadays, with our scientific knowledge of porphyria, instead of fearing these folks, we can love and care for them. Porphyria remains incurable, and treatment is mainly supportive: pain control, fluids and avoidance of drugs and chemicals that provoke acute attacks. Some success has been achieved with stem cell transplants.

Could Stoker have known of the existence of porphyria, and/or its link to vampire folklore? It was only in 1911, eight years before Stokers book appeared, that the diseases of porphyria (there are several types) were classified by H. Gunther. However, physician, researcher and author George Harley had described a patient with porphyria a few years earlier.

Through his gothic novel, Stoker surely wins the prize for the best example of myth entangled with medicine!

This story is an edited excerpt from the book Of Plagues and Vampires: Believable Myths and Unbelievable Facts from Medical Practice by Michael Hefferon.

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Vampire myths originated with a real blood disorder - The Conversation CA

Skin Stem Cells Comments Off on Vampire myths originated with a real blood disorder – The Conversation CA | June 24th, 2020

MOST people know breastfeeding is one of the best ways to help a baby thrive. And now it seems a mother's milk has beneficial effects even when her child reaches adulthood.

New University of Toronto research has found that if people genetically at risk of becoming obese are exclusively breastfed as a baby it can help ward off weight gain when they're young adults.

The study is part of a growing body of evidence about the benefits of breastfeeding yet the World Health Organisation says nearly two out of three infants aren't exclusively breastfed for the recommended six months a rate that hasn't improved in 20 years.

When asked, 80 per cent of the women who stopped breastfeeding before six months said they would have liked to continue for longer, but often lacked support and guidance.

"Our society is letting mothers down there needs to be much more investment in breastfeeding support and education," says NCT breastfeeding counsellor Cordelia Uys, a breastfeeding expert for the holistic new mums' wellness app Biamother (biamother.com).

"Breastfeeding confers numerous health protections on both mother and child and creates a strong sense of emotional connection. In addition, for a mother to see her baby growing and thriving on her milk can be one of the most satisfying and rewarding experiences of her life."

Here, Uys outlines ten surprising breastfeeding facts...

1. Breast milk is personalised medicine

There are numerous antiviral and antibacterial properties in breast milk that protect a baby from infection. These infection-fighting properties are being continually updated in response to the mother and baby's environment. When a mother's body encounters a new germ, her mature immune system will deploy millions of white blood cells to fight it off and quickly pass them on to her baby via her milk.

2. Breast milk contains stem cells

Every time a mother breastfeeds her baby, stem cells in her breast milk cross the baby's gut and into their blood, and then travel to all the baby's organs, including their brain. These stem cells are capable of becoming functioning cells all over the infant's body. It's believed they can boost and support the infant's optimal development and protect them against infectious diseases.

3. Breastfeeding has to be learned

Many people think breastfeeding will come naturally to mothers, but in fact, for all female apes, breastfeeding is a learned behaviour. A juvenile female gorilla in Ohio Zoo, having been separated from her mother at a young age, had no idea how to feed her first baby. But during her second pregnancy, zookeepers had the inspired idea of asking human mothers to regularly breastfeed their babies in front of her. When her second baby was born, the gorilla immediately picked it up and put it to the breast.

In the past, human mothers would have learned how to breastfeed by watching relatives and friends. For this reason, it's a good idea for pregnant women who want to breastfeed, to spend some time with a friend who's successfully nursing her baby. The National Breastfeeding Helpline and apps can also offer advice on breastfeeding.

4. Over 95 per cent of women can produce all the milk their baby needs

The vast majority of women can make all the milk their baby needs and, contrary to popular belief, the size of a woman's breasts doesn't impact the volume of milk she can produce.

Milk production depends entirely on supply and demand: in the early months, milk needs to be removed effectively from both her breasts at least eight times in 24 hours for a mother's supply to be established and maintained. By far the most common reason for low milk supply is under-stimulation of a mother's breasts, either because her baby isn't feeding frequently enough or isn't removing milk effectively.

5. Breastfeeding acts as a natural painkiller

Breast milk contains natural painkillers called endocannabinoids. Breastfeeding before and during vaccination injections has been shown to reduce pain in babies.

6. Breastfeeding protects mothers against breast cancer

The Tanka Fisherwomen of Southern China traditionally only breastfeed their babies from their right breast. In the early 1970s, a medical student at a Hong Kong clinic noticed that if Tanka women developed breast cancer, in 79 per cent of cases, it was in their left breast. It was this observation that led to the discovery that breastfeeding is protective against breast cancer.

7. Breastfeeding shouldn't hurt

Pain is there to tell us something is wrong, and this is true for breastfeeding too. Pain and damage happen when a mother's nipple isn't positioned correctly in her baby's mouth. In the majority of cases, when a baby is well-positioning and deeply latched, breastfeeding will be completely comfortable. If breastfeeding hurts, it's important to seek out qualified support as soon as possible.

8. The temperature of a mother's breasts adapts to her baby's needs

A mother's breasts can warm up by 2C if the baby is too cold, and cool down by 2C if the baby is too hot. In fact, it has been shown that when newborn twins are placed in skin-to-skin contact with their mother, each of her breasts will heat up to a different temperature according to each baby's needs. This is called thermal synchrony.

9. Breastfeeding mothers get more sleep

Studies have shown breastfeeding mothers sleep on average 45 minutes more a night than mothers who formula feed. Human milk contains substances that promote sleep and calmness in babies. Mothers release the hormone prolactin into their own blood while breastfeeding, which helps them to fall asleep more easily.

10. Breastfeeding is carbon neutral

When a mother is breastfeeding, there is zero waste and no carbon emissions. Research at Imperial College London has shown breastfeeding for six months saves an estimated 95-153kg CO2 equivalent per baby compared with formula feeding.

:: National Breastfeeding Helpline (nationalbreastfeedinghelpline.org.uk): 0300 100 0212

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10 surprising facts about breastfeeding - The Irish News - The Irish News

Skin Stem Cells Comments Off on 10 surprising facts about breastfeeding – The Irish News – The Irish News | June 23rd, 2020

Peptide-drug conjugates TH1902 and TH1904 show significant reduction in the formation of vasculogenic mimicry by targeting the sortilin receptor

Curcumin shows increased anticancer activity when conjugated to proprietary peptide

SORT1+ technology significantly widens therapeutic window of traditional cytotoxic cancer treatments

MONTREAL, June 22, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that new data featuring its investigational sortilin 1 (SORT1)-targeting peptide-drug conjugate technology will be presented in three posters at the American Association for Cancer Researchs virtual annual meeting II.

We believe that our SORT1+ technology is one of the most promising advances in the treatment of cancer in many years. As our oncology programs progress through clinical development, we hope to continue to demonstrate that our SORT1+ technology could become a new paradigm in cancer treatment, said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

Inhibition of Vasculogenic MimicryThe formation of microvascular channels leads to aggressive, metastatic and resistant cancer cells and is known as vasculogenic mimicry (VM). VM is believed to be associated with tumor growth, resistance and poor prognosis in many types of aggressive cancers including ovarian and triple-negative breast cancer (TNBC).

Results presented at AACR indicate that SORT1 is highly expressed in cancer cells involved in the VM process in both ovarian cancer and TNBC. In addition, CD133, a gene associated with cancer stem cells, is also highly expressed during VM formation. Theratechnologies SORT1-targeting peptide-drug conjugates TH1902 (peptide-docetaxel conjugate) and TH1904 (peptide-doxorubicin conjugate) strongly inhibit VM at very low doses. When administered alone, docetaxel and doxorubicin show no effect at therapeutic doses.

The data presented in this study demonstrate that by targeting SORT1, TH1902 and TH1904 have the potential to inhibit VM and cancer cell growth. This ground-breaking approach could lead to better efficacy in the treatment of resistant cancers, continued Dr. Marsolais.

The poster Sortilin receptor-mediated novel cancer therapy: A targeted approach to inhibit vasculogenic mimicry in ovarian and breast cancers is now available online at aacr.org

Optimizing the potential of known natural anticancer agentsScience has identified several compounds in nature that have cancer-fighting potential. However, these compounds are often unstable or need to be taken in quantities that are unrealistic.

Phytochemicals found in plants, such as curcumin, are proven to have antiproliferative, antiangiogenic and apoptotic properties against various cancers such as colorectal, ovarian and breast cancers. However, when administered alone, these phytochemicals have low bioavailability and are rapidly degraded and poorly absorbed through the gastro-intestinal tract.

The results of a preclinical study, where curcumin was conjugated with Theratechnologies proprietary peptide (peptide-curcumin conjugate) and delivered directly to cancer cells, show that TH1901 has 50 to 100 times greater anti-cancer activity than curcumin alone in ovarian, breast, melanoma and colorectal cancer models in vitro.

In several in vitro cancer models, TH1901 significantly increases the penetration of curcumin inside cancer cells thereby reducing inflammation and inhibiting tumor growth. These results demonstrate the improved efficacy of only one of many natural compounds that could be studied using our SORT1+ technology and indicate how truly versatile this technology is, concluded Dr. Marsolais.

The poster TH1901, a novel Curcumin-peptide conjugate for the treatment of Sortilin-positive (SORT1+) cancer is now available online at aacr.org

Better efficacy and absence of neutropenia with TH1902 in triple-negative breast cancer TNBC, which represents approximately 10 to 20% of breast cancers, does not express estrogen receptors, progesterone receptors or human epidermal growth factor receptor 2 (HER2). It is more aggressive than other breast cancers and it has been observed that TNBC overexpresses SORT1 receptors.

In a poster presented at AACR, preclinical data demonstrate that in vitro TH1902 leads to significantly better efficacy at a lower dose when compared to docetaxel alone. In the same study, TH1902 also shows similar efficacy to therapeutic doses of docetaxel when administered only at one-quarter of the indicated dose of docetaxel. When administered alone, docetaxel showed no treatment effect at the one-quarter dose.

In addition, the safety profile of TH1902 was superior to docetaxel as it did not induce neutropenia even after six treatment cycles. A single 15mg/kg dose of docetaxel alone was enough to induce neutropenia.

The poster A novel Sortilin-targeted docetaxel peptide conjugate (TH1902), for the treatment of Sortilin-positive (SORT1+) triple-negative breast cancer is now available online at aacr.org

About Theratechnologies SORT1+ technologyTheratechnologies has developed a peptide which specifically targets Sortilin (SORT1) receptors. SORT1 is overexpressed in ovarian, triple-negative breast, skin, lung, colorectal and pancreatic cancers, among others. SORT1 plays a significant role in protein internalization, sorting and trafficking, making it an attractive target for drug development.

Commercially available anticancer drugs, like docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated to Theratechnologies investigational novel peptide to specifically target Sortilin receptors. This could potentially improve the efficacy and safety of those agents.

Theratechnologies intends to submit an IND to the FDA for a first -in-human clinical trial for TH1902 before the end of 2020.

The Canadian Cancer Society and the Government of Quebec, through the Consortium Qubcois sur la dcouverte du medicament (CQDM), will contribute a total of 1.4 million dollars towards some of the research currently being conducted for the development of Theratechnologies targeted oncology platform.

About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a commercial-stage biopharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. Further information about Theratechnologies is available on the Company's website at http://www.theratech.com, on SEDAR at http://www.sedar.com and on EDGAR at http://www.sec.gov

Forward-Looking Information This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our managements beliefs and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", would, "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the effects, safety and efficacy of Theratechnologies SORT1-targeting peptide-drug conjugate technology on the potential treatment of various types of cancer and the timelines to initiate a first-in-human clinical trial with TH1902 in patients with cancer.

Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: all SORT1-targeting peptide-drug conjugates will be as effective and safe in humans as in mice and in vitro and in vivo results obtained thus far and will be replicated into humans leading us to pursue the development of these peptide-drug conjugates, and no event will occur resulting in a delay in initiating a first-in-human clinical trial with TH1902 by the end of 2020.

Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, the risk that results (whether safety or efficacy, or both) obtained through the administration of our SORT1-targeting peptide-drug conjugates into humans are different than into mice; difficulty in recruiting patients to begin a phase I clinical trial; further results using our SORT1-targeting peptide-drug conjugates may not replicate the results obtained thus far which could lead us to delay or to stop the pursuit of additional studies, and; discovery or introduction of new treatments on the market for the treatment of cancer that we intend to develop our SORT1-targeting peptide-drug conjugates for could prove safer and more effective than our peptides.

We refer potential investors to the "Risk Factors" section of our annual information form dated February 24, 2020 available on SEDAR at http://www.sedar.com and on EDGAR at http://www.sec.gov as an exhibit to our report on Form 40-F dated February 25, 2020 under Theratechnologies public filings for additional risks regarding the conduct of our business and Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date.

We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.

For media inquiries:Denis BoucherVice President, Communications and Corporate Affairs514-336-7800

For investor inquiries:Leah GibsonSenior Director, Investor Relations617-356-1009

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New Data Show Theratechnologies' SORT1+ Technology is Effective in Many Treatment-Resistant Cancers - GlobeNewswire

Skin Stem Cells Comments Off on New Data Show Theratechnologies’ SORT1+ Technology is Effective in Many Treatment-Resistant Cancers – GlobeNewswire | June 23rd, 2020

In order to understand how COVID-19 spreads throughout the body, ravaging it in myriad ways, doctors are growing miniature balls or organ-like tissue called organoids, and infecting them again and again.

The results, Nature News reports, are particularly troubling: the miniature lungs, livers, kidneys, hearts, intestines all showed signs of damage. The series of studies reveals with shocking clarity that COVID-19 can cause far more than a lung infection.

Of course, thats not exactly news. This harrowing list of survivors and medical workers horror stories gathered by SFGate includes heart attacks, strokes, long-term lung damage, incontinence, skin damage, and other serious complications for supposed mild cases of the coronavirus:

Thats just one of the many, many stories they gathered about the ways a road to recovery from COVID-19 is neither linear nor something that shouldnt be feared.

That said, for all their benefits, organoids are still imperfect. Per Nature, theyre far more simplistic than a full-sized organ. And because theyre not all connected in the same body, doctors can only use them to study the impacts on a single organ in isolation.

We know the cells die but we dont know how, Weill Cornell Medicine stem cell biologist Shuibing Chen told Nature of her study on miniature lungs.

Even though questions remain, its clear those impacts are serious. Various studies found that the coronavirus caused serious damage in several organs, and may lead to indirect damage in others. It also became clear that the coronavirus can infect and spread through blood vessels, leading to a more serious, widespread case.

To figure that out, biologists will need to develop more sophisticated and realistic organoids and try their experiments again, Nature reports.

It is too early to say how relevant they are, Bart Haagmans, an Erasmus MC virologist who ran a study on gut organoids, told Nature.

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Mini-Organ Research Reveals What COVID-19 Does to the Body - Futurism

Skin Stem Cells Comments Off on Mini-Organ Research Reveals What COVID-19 Does to the Body – Futurism | June 23rd, 2020

Influencers and beauty enthusiasts will fall head over heels with Morphe Cosmetics new collaboration. This summer, Americas beloved beverage brand Coca-Cola and Morphe are set to launch the most flashiest limited-edition makeup collection ever. Both brands came together to craft a plethora of shimmering colors that range from nudes to darker tones. Were sure, it will be sold out before you can finish your drink. This is the first time The Coca-Cola Company has invested in a giant beauty brand like Morphe. Live it up with our Thirst For Life, announced Morphe on their social media showcasing their new matte and glitter shades for the eyes, lips and face.

This collaboration will only be available in selected countries including theUS, UK, Canada and Australia starting June 18th on Morphe.com. The collection features a Thirst For Life Artistry Palette $22, a seven-piece brush collection with bag $29, Glowing Places Loose Highlighter $15, Lip In The Moment lip collection $19, and The Quench Pack sponge collection, $15. South African model, Carmen Lee Solomons and Asias Next Top Model, Julian Aurine surprised their fans with the killer campaign and showed a sneak peek of the collection while wearing the sparkly shades. The best part about this iconic partnership is the versatility in colors. From ice-cold blues and iconic reds to energizing neutrals, there are 18 colors to choose from.

Read more here:
Coca-Cola and Morphe announced a refreshing makeup collab - HOLA USA

Skin Stem Cells Comments Off on Coca-Cola and Morphe announced a refreshing makeup collab – HOLA USA | June 23rd, 2020