KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Mercks anti-PD-1 therapy, received new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in advanced renal cell carcinoma (RCC) and head and neck cancer for the following additional indications in Japan:

Advanced renal cell carcinoma and head and neck cancer have historically been associated with poor outcomes and new treatment options are needed in Japan, said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. Todays approval of three new first-line KEYTRUDA regimens represents a significant milestone for patients diagnosed with these aggressive forms of cancer and will provide patients in Japan with important alternatives to standard therapies.

The approval for KEYTRUDA in combination with axitinib for radically unresectable or metastatic RCC is based on results from the KEYNOTE-426 trial, in which KEYTRUDA in combination with axitinib demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) (HR=0.53 [95% CI, 0.38-0.74]; p=0.00005) and progression-free survival (PFS) (HR=0.69 [95% CI, 0.56-0.84]; p=0.00012) compared to sunitinib monotherapy.

The approval for KEYTRUDA for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer is based on results from the Phase 3 KEYNOTE-048 trial which evaluated KEYTRUDA in combination with platinum and 5-fluorouracil (5-FU), or KEYTRUDA monotherapy compared with standard treatment (cetuximab in combination with platinum and 5-FU), as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma. In the trial, KEYTRUDA in combination with platinum and 5-FU significantly prolonged OS (HR=0.77 [95% CI, 0.63-0.93]; p=0.00335) compared with standard treatment. As monotherapy, KEYTRUDA demonstrated non-inferiority (HR=0.85 [95% CI, 0.71-1.03]; p=0.00014) compared with standard treatment. Additionally, KEYTRUDA monotherapy demonstrated a statistically significant improvement in OS in patients whose tumors expressed PD-L1 (CPS 1) compared with standard treatment.

Last year, an estimated 850,000 new cancer diagnoses were made in Japan alone, underscoring the critical need for innovative research and development to identify additional treatment options, said Jannie Oosthuizen, managing director of MSD in Japan. The new approvals of KEYTRUDA in advanced renal cell carcinoma and head and neck cancer build on previous approvals in melanoma, advanced non-small cell lung cancer and advanced MSI-H cancers, allowing us to bring KEYTRUDA to even more patients in Japan.

Renal cell carcinoma is by far the most common type of kidney cancer, with approximately 403,000 cases of kidney cancer diagnosed worldwide in 2018 and about 175,000 deaths from the disease. In Japan, it is estimated there were more than 24,000 people diagnosed with kidney cancer, and more than 8,000 deaths occurred in 2018.

Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. It is estimated that there were more than 705,000 new cases of head and neck cancer diagnosed and over 358,000 deaths from the disease worldwide in 2018. In Japan, it is estimated that more than 22,000 new cases of head and neck cancer were diagnosed, and more than 8,000 deaths occurred in 2018.

About KEYTRUDA (pembrolizumab) Injection

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 1,000 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 patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected Indications for KEYTRUDA (pembrolizumab) in the U.S.

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 one 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.

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).

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 hypophysitis, thyroid disorders, and type 1 diabetes mellitus. 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 hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 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; 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%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 34) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 34) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent (1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%); the most common were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). The most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

See more here:
Merck's KEYTRUDA (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or...

Cardiac Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or… | December 20th, 2019

ROCHESTER, Minn. Stem cells derived from a patient's own fat offer a step toward improving not just stabilizing motor and sensory function of people with spinal cord injuries, according to early research from Mayo Clinic.

A clinical trial enrolled 10 adults to treat paralysis from traumatic spinal cord injury. After stem cell injection, the first patient demonstrated improvement in motor and sensory functions, and had no significant adverse effects, according to a case report published in Mayo Clinic Proceedings.

Watch: Chris Barr's Mayo Clinic story.

Journalists: Broadcast-quality video (5:12) is in the downloads at the end of this post. Please "Courtesy: Mayo Clinic News Network." Read the script.

As a phase I multidisciplinaryclinical trial, the study tests the safety, side effects and ideal dose of stemcells. Early trial findings show that patient response varies. The Mayo teamplans to continue analyzing patient responses, and further results will bepublished on the other nine trial participants.

Read more from the study team in this Center for Regenerative Medicine blog post.

"In this case report, the first patient was a superresponder, but there are other patients in the trial who are moderate responders and nonresponders," says Mohamad Bydon, M.D., a Mayo Clinic neurologic surgeon and first author of the report. "One of our objectives in this study and future studies is to better delineate who will be a responder and why patients respond differently to stem cell injections.

"The findings to date will be encouraging to patients with spinal cord injuries, as we are exploring an increasing array of options for treatment that might improve physical function after these devastating injuries."

Between 250,000 and 500,000 people worldwide suffer a spinal cord injury each year, often with life-changing loss of sensory and motor function, according to the World Health Organization. Up to 90% of these cases are from traumatic causes.

All subjectsenrolled in this study received fat-derived stem cell treatment, which isexperimental and is not approved by the Food and Drug Administration (FDA) forlarge-scale use. However, the FDA allowed its use in this research.

In the case report, the patient, then 53, injured the spinal cord in his neck in a 2017 surfing accident. He suffered a complete loss of function below the level of injury, meaning he could not move or feel anything below his neck. He had surgery to decompress and fuse his cervical vertebrae. Over the next few months, with physical and occupational therapy, he regained limited ability to use his arms and legs, and some sensory function improved. However, his progress plateaued at six months after his injury.

The patient enrolled in the study nine months after his injury.His stem cells were collected by taking a small amount of fat from his abdomen.Over eight weeks, the cells were expanded in the laboratory to 100 millioncells. Then the stem cells were injected into the patient's lumbarspine, in the lower back, 11 months after his injury.

"We want to intervene when the physical function has plateaued, so that we do not allow the intervention to take credit for early improvements that occur as part of the natural history with many spinal cord injuries. In this case, the patient was injected with stem cells nearly one year after his injury," Dr. Bydon says.

The patient was observed at baseline and at regular intervals over 18 months following injection. His physical therapy scores improved. For example, in the 10-meter walk test, the patient's baseline of 57.72 seconds improved at 15 months to 23 seconds. And in the ambulation test, the patient's baseline of 635 feet for 12.8 minutes improved at 15 months to 2,200 feet for 34 minutes.

Thepatient's occupational therapy scores also improved, such as grip and pinchstrength, and manual dexterity. His sensory scores improved, with pin prick andlight touch tests, as did his mental health score.

Thestem cells migrate to the highest level of inflammation, which is at the levelof spinal cord injury, but the cells' mechanism of interacting with the spinalcord is not fully understood, Dr. Bydon says. As part of the study,investigators collected cerebrospinal fluid on all of the patients to look forbiological markers that might give clues to healing. Biological markers areimportant because they can help identify the critical processes that lead to spinalcord injury at a cellular level and could lead to new regenerative therapies.

"Regenerative medicine is an evolving field," says Wenchun Qu, M.D., Ph.D., a Mayo Clinic physiatrist and pain specialist, and senior author of the report. "Mayo's research and use of stem cells are informed by years of rigorous scientific investigation. We strive to ensure that patients who receive stem cells are fully educated in the risks, benefits, alternatives and unknowns about these therapies. Through our clinical trials with stem cells, we are learning from and improving these procedures."

Further study is needed to scientifically verify the effectiveness of stem cell therapy for paralysis from spinal cord injury, the authors note. It is uncertain when or if this procedure will have FDA approval for routine clinical care.

Other researchers involved in this study were Allan Dietz, Ph.D.; Sandy Goncalves; F.M. Moinuddin, Ph.D.; Mohammed Ali Alvi, M.B.B.S.; Anshit Goyal, M.B.B.S.; Yagiz Yolcu, M.D.; Christine Hunt, D.O.; Kristin Garlanger, D.O.; Ronald Reeves, M.D.; Andre Terzic, M.D., Ph.D.; and Anthony Windebank, M.D. all from Mayo Clinic.

The cell product was developed and manufactured in the Mayo Clinic Immune, Progenitor and Cell Therapeutics (IMPACT) Lab directed by Dr. Dietz.

This research was funded by grants from Regenerative Medicine Minnesota and Mayo Clinic Transform the Practice and supported by Mayo Clinic Center for Regenerative Medicine.

The authors have norelevant disclosures or conflicts of interest to report.

###

About Mayo Clinic ProceedingsMayo Clinic Proceedingsis a monthly peer-reviewed medical journal that publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research, and clinical epidemiology. Mayo Clinic Proceedings is sponsored by the Mayo Foundation for Medical Education and Research as part of its commitment to physician education. It publishes submissions from authors worldwide. The journal has been published for more than 90 years and has a circulation of 127,000. Visit the Mayo Clinic Proceedings website to view articles.

About Mayo Clinic Center for Regenerative MedicineMayo Clinic Center for Regenerative Medicine seeks to integrate, develop and deploy new regenerative medicine products and services that continually differentiate Mayo's practice to draw patients from around the world for complex care. Learn more on the Center for Regenerative Medicine website.

About Mayo ClinicMayo Clinicis a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing.Visit the Mayo Clinic News Networkfor additional Mayo Clinic news andAn Inside Look at Mayo Clinicfor more information about Mayo.

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Case report: Stem cells a step toward improving motor ...

Spinal Cord Stem Cells Comments Off on Case report: Stem cells a step toward improving motor … | December 20th, 2019

Gurugram/New Delhi, Dec 19 : In a ground-breaking procedure, Haematologists and Bone Marrow Transplant specialists successfully treated Anurag Mishra, a 47-year-old man from New Delhi, suffering from Multiple Sclerosis (MS) from the past seven years.

The most common symptoms of MS include loss of sensation and balance, restricted arm or leg movement and vision loss in one or both the eyes.

Mishra, who was bedridden earlier, is back to his normal routine life, was diagnosed with MS an autoimmune neurodegenerative disease, where the body's own defence system starts attacking its nervous system, without any specific reason

Unlike the current line of MS treatment, which mainly includes steroid therapy, physiotherapy and symptom management, doctors used Bone Marrow Transplant (BMT).

Dr Rahul Bhargava, Director, Department of Clinical Hematology iamp; Bone Marrow Transplant, Fortis Hospital in Gurugram with his team performed autologous bone marrow transplant where they used Mishra's stem cells for transplant, thereby reducing the chances of rejection and infections.

"In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved. Chemotherapy is then administered to reset the body's immunity and then the stem cells are injected back to rescue the person from the side effects of chemotherapy," said Bhargava.

After the surgery, the patient is kept under isolation for a few months to ensure he/she does not contract any infection. In this case, when Mr Anurag approached us, he was entirely dependent on others for his basic needs. But within six months after the treatment, he is back on his legs and is carrying on with his normal life," Bhargava added.

According to the patient, the attacks are sudden and may affect any part of your body, limiting your abilities.

"Extreme pain and disabilities this disease gave, made me very scary and depressing. I think I am very lucky to get to know about Dr Rahul Bhargava and team, who cured me miraculously," Mishra said.

"Too much delay in the procedure can considerably affect the clinical outcomes. In the case of Mr Anurag, recovery is 90 per cent, which means he received the treatment within recovery time-frame," Dr Bhargava said.

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47-year-old successfully treated with bone marrow transplant | newkerala.com News #267197 - New Kerala

Spinal Cord Stem Cells Comments Off on 47-year-old successfully treated with bone marrow transplant | newkerala.com News #267197 – New Kerala | December 20th, 2019

Welcome back to Worth It, a bi-weekly breakdown of the new beauty products Ive tested and adored: Im talking that drain-it-to-the-bottom-and-tell-my-friends-Ive-found-The-One kind of love. If it's featured here, consider this my permission to splurge on it. Read on for the product you dont want to live without, and catch up on the latest Worth It breakdown here.

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The Cream

$170.00

When you try The Cream, it comes at a price. You know, not your soul or an Infinity Gauntlet situation, but it's hefty nonetheless: $265 for 50 mls of the world-famous lotion. That said, its a skincare nerds dream. Bader, a professor and director of Applied Stem Cell Biology and Cell Technology at the University of Leipzig in Germany, is considered the top scientist in the world on the subject of regenerative tissue. His work, particularly his extensive studies on disfiguring burns and wound healing, led him to create the illustrious cream: The formulas secret is its TFC8 (Trigger Factor Complex 8), a proprietary blend that the brand says will activate the bodys own stem cells to promote major anti-aging benefits like minimized lines, even tone, and redness-reduction.

Ive been aware of the product's cult-status for years, but I honestly just tried it for shits-and-gigs. My skin is typically easily managed: I get ruddy and dry, and I tend to develop tiny, under-the-skin bumps on my cheeks after I sleep on hotel sheets (should I forget my Slip pillowcase). On rare occasions, Ill wake up with a pimple thats so mountainous and painful that I wonder if I contracted staph on the F train. But for the most part, I have good skin, and Im grateful for it. Thats why I typically seek out products that impart glowiness and hydration rather than something to totally overhaul my facebut that's exactly what The Cream claims to do.

Despite my dry skin type, I chose the original formula rather than the Rich Cream (I prefer lighter textures when it comes to moisture). I also didnt adhere to the proper instructions: Bader recommends using it for 27 days, minimum, with no additional skincare products except for cleanser, but I couldnt bring myself to abandon the rest of my arsenal. Instead, I used this as my last step in both my morning and evening routines.

My makeup went on smoothly in the mornings, but my off-dry skin never felt truly quenched before bed unless I applied a hydrating serum underneath. Meh. Yet, after about three weeks, I started to receive an onslaught of complexion compliments. I guess I havent looked as red recently, I thought. And I didnt have any active pimples, so I didnt think much of it. Ill take a good skin week anytime.

But one morning, mid-glam, I realized Id forgotten to apply both foundation and concealer and had gone straight for my Nudestix blush stick. I genuinely couldnt tell if Id put my complexion makeup on. Peter Parker getting stuck to the ceiling on his first morning as Spiderman? Same level of confusion. I took a closer look, skeptical. Do I look amazing?

Rather than that translucent, un-plump look my skin usually has in the morning, it appeared stronger, almost thicker. My fair tone was even and clear, and my typical little dark circles were nowhere to be found, seemingly buried underneath my reinforced complexion.

I do. I look fucking amazing.

I suddenly felt invinciblelike my own more stunning evil twin, or a supervillain whod traded their lovers heart for immense power and was rewarded with that golden, CGI glow-from-within that comes with Marvel-sanctioned immortality. I was transformed, and the expensive blue bottle on my dresser was the precious source of my new supremacy.

Ive been using The Cream ever since (about three months now) and my complexion has a whole new baseline. When people ask if it's really worth it, rather than offer a cheaper alternative like I typically do with products this expensive, I answer: This shit is wild.

For more stories like this, including celebrity news, beauty and fashion advice, savvy political commentary, and fascinating features, sign up for the Marie Claire newsletter.

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Augustinus Bader's The Cream Review - MarieClaire.com

Skin Stem Cells Comments Off on Augustinus Bader’s The Cream Review – MarieClaire.com | December 19th, 2019

In a process similar to 3D printing, it is possible to artificially create tissues by using cells and biomaterials. Bioprinting has allowed scientists to create organoids, meat, skin and bones. Researchers from Brazil have now bioprinted, mini-livers that can perform all the functions of a liver.

The printed organoid can produce vital proteins, store vitamins, secrete bile, and all the other functions that are carried out by a liver. Researchers from the Human Genome and Stem Cell Research Center (HUG-CELL) at the University of So Paulo (USP) can create the miniature liver in just 90 days.

Researchers in their study published in the journal, Biofabrication used various bioengineering techniques to come up with a new method to print organoids. Normally, bioprinting uses bioink made up of cells and other biomaterials to print tissues layer-by-layer just like 3D printing.

Instead of just cells, researchers used clumps of cell, which they called spheroids in the bioink. The use of spheroids substantially extended the life of organoids, compared to previous studies, as they were able to avoid the gradual loss of contact between cells.

SEE ALSO: Researchers Have Found A Way To Print Complex Living Tissue In A Matter Of Minutes

By reprogramming blood cells obtained from three people, researchers created induced pluripotent stem cells (iPSCs). The stem cells are then transformed into hepatocytes, vascular cells, and mesenchymal cells that make up the hepatic tissues of the liver. The spheroids, consisting of these cells are then mixed with a hydrogel-like fluid to make the bioink that can be used to create liver organoids.

The director of HUG-CELL, Mayana Zatz explained, In the very near future, instead of waiting for an organ transplant, it may be possible to take cells from the patient and reprogram them to make a new liver in the laboratory. Another important advantage is zero probability of rejection, given that the cells come from the patient.

SEE ALSO: Researchers Create 3D-Printed Human Skin And Bone To Help Astronauts On Mars

Image Credit: Daniel Antonio/Agncia Fapesp

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Researchers Have 3D-Printed A Functional Miniature Liver - Mashable India

Skin Stem Cells Comments Off on Researchers Have 3D-Printed A Functional Miniature Liver – Mashable India | December 19th, 2019

Last Christmas a student from London received what he says was the best Christmas present ever the chance to save a strangers life.

Will Briant, 23, from Kennington, was found to be the best match for a patient with blood cancer in desperate need of a stem cell transplant. Will recently received a letter informing him that his anonymous recipients transplant had been a success and that he is now doing well.

Will initially joined the Anthony Nolan stem cell register in 2014. His girlfriend, who volunteered with Edinburg Universitys Blood, Bone Marrow and Transplant Society, which is part of blood cancer charity Anthony Nolans student volunteer network called Marrow, suggested that he sign up.

Will said: My girlfriend, Libby, told me this amazing statistic that a quarter of all stem cell donors sign up through Marrow at university, so I couldnt not join.

If it wasnt for Marrow and for Libby, I wouldnt have become a donor and given someone hope of a second chance of life just before Christmas.

After Will joined the Anthony Nolan register the charity confirmed his tissue type. Every time the charity was informed that someone needed a transplant it compared the patients tissue type to Wills and over 750,000 others on the register, as well as registers across the world.

In December last year, Will received an email from Anthony Nolan, informing him that he had come up as a potential match for a blood cancer patient in desperate need of a stem cell transplant. Will then went to his GP for blood tests, to confirm that he was in fact the best possible match.

Will said: Just a week before Christmas, I got the best Christmas present ever. I was told that I was the best match for the patient, and I would be donating early in the new year!

I was so excited. When you sign up you know that its such a tiny chance that youll be found as the best match for someone, so to actually be chosen felt really exciting. Also, because it was just before Christmas, it felt quite exciting to know that the patient would find out that they had a match just in time for Christmas!

On average, people who join the stem cell register have around a 1 in 800 chance of being asked to donate in the next five years, but for men aged 16-30, its 1 in 200. This is why Anthony Nolan need more young men to join the register.

At the beginning of this year, having spent Christmas at home with his family, Will donated his stem cells at The London Clinic.

Will said: For four days before the donation I had a course of G-CSF injections to increase the number of stem cells I was producing. This caused mild flu-like symptoms, I just felt a bit tired and achy really. The whole way through, I kept thinking about the recipient, and how, in this context, I was absolutely delighted to have mild flu-like symptoms! It was quite strange to be doing it for real, after talking to so many potential donors when I volunteered with Marrow at university!

Libby, the same girlfriend who had suggested Will consider signing up to the register four years earlier, accompanied him to his donation.

Will said: I sat in a hospital bed for four hours and was so pampered by the staff there! There was a huge choice of different lunches, endless coffees and I got to watch programmes on my iPad.

Following his donation Will then went back to his studies and his job, barely giving a second thought to what hed just done. However, this all changed when a month after the donation he received a letter of thanks from the recipient of his stem cells.

Will said: It was honestly the best letter Ive ever received. It was especially powerful because it really hit home, that not only had I given him a second chance of life, but also, I had given his wife, his children, his grandchildren and his friends more precious time with him.

Patients and recipients must remain anonymous for two years following a transplant, but they are able to communicate via anonymous letters and cards. After the two-year period, if both parties agree, they are allowed to meet.

Just recently, Will also received a letter from the hospital at which his recipient received their stem cell transplant to say that the donation had been successful and even though recovery can be a long process, he is currently recovering well. Will is hoping that they will both exchange Christmas cards this year.

Anthony Nolan is the charity that finds matching stem cell donors for people with blood cancer and blood disorders and gives them a second chance of life. It costs 40 for Anthony Nolan to add each new donor to the register, so the charity needs financial support to help it continue to give patients, their family and their friends hope.

Terence Lovell, Director of Engagement at Anthony Nolan told Charity Today: Our amazing stem cell donors, like Will, continue to enable many patients with blood cancer to spend Christmas with their loved ones, who wouldnt be here without their act of kindness.

Anyone wanting to support our work can visit our website and make a donation, which will help give someone like Wills recipient, a second chance of life in the future. Without your support, there is no cure.

Anthony Nolan also carries out ground-breaking research to save more lives and provide information and support to patients after a stem cell transplant, through its clinical nurse specialists and psychologists, who help guide patients through their recovery. Find out more about Anthony Nolan this Christmas by visitinghttps://www.anthonynolan.org/

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'Last Christmas...' London student saved a stranger's life, this year he is alive and celebrating his gift of life - Charity Today News

Bone Marrow Stem Cells Comments Off on ‘Last Christmas…’ London student saved a stranger’s life, this year he is alive and celebrating his gift of life – Charity Today News | December 19th, 2019

As a new mother, she didnt know to look for blue-tinged lips. She could just tell her babys color was off. On a chest X-ray, the clean, white-against-dark curves of his ribs were obscured, clouded by fluid. Pneumonia. That tipped Ray Ballards physicians off: He had a form of severe combined immunodeficiency SCID, for short a genetic mutation that hampered the growth of crucial immune cells, leaving him utterly vulnerable to infection.

The best fix was a transplant of his mothers bone marrow. The attitude was that in three to six months, you should be able to go back to normal life, recalled his mom, Barb Ballard.

That was true at least sort of. He got two more booster transplants before he hit 10. An antibiotic left him with hearing loss, and a virus with digestive tract damage. His lack of B cells meant he needed regular injections of other peoples antibodies, and his T cell counts were never ideal. But he was healthy enough to go to public school, to move through the hallways high-fiving half the guys, to slowly inhale and take aim during rifle team practice.

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His T cells had to be working well enough that he wasnt coming down with everything that walked into the classroom, Ballard said.

Then, when Ray was around 18, his immunity began to wane. For him, it came in the form of a norovirus he couldnt shake. For others with the same rare disease, it appears as pneumonia or gastrointestinal trouble or an unexpected T cell decline. Over the last 10 years, the trend has become increasingly clear: The bone marrow transplants that kept certain babies with SCID alive sometimes stop working after years or decades of providing fairly reliable immune defenses.

Now, to patient advocates, this has become an urgent lesson in the language people use to talk about treatment and not just for SCID. They see their communitys experience as a cautionary tale for anyone developing or receiving a therapy thats marketed as potentially curative.

Theres an expectation and a hope: When they hear about bone marrow transplants, it sounds like a lifetime deal, a forever fix, said John Boyle, president and CEO of the Immune Deficiency Foundation. Weve discovered, as a result of this issue, that bone marrow transplant ended up not being the forever fix we thought it was.

Experts have known for years that some of these transplants wouldnt provide full immune protection over the course of a SCID patients entire life. They say clinicians should have avoided the word cure. But even scientific papers that hinted at such complications called the treatment curative. Just this year, an Immune Deficiency Foundation employee was given the unenviable task of sifting through the organizations thousands of pages of online material, scrubbing out every cure that popped up. It was only there a handful of times sometimes in quotes from clinicians, Boyle said but it was there and it needed to be removed.

The language patients hear can sometimes even change their outcomes. Weve heard of cases where, years later, they realized their immune system isnt as healthy as they thought, but nobody was tracking that because they hadnt maintained a relationship with the physician, or the physician didnt maintain a relationship with them, explained Ballard. The word cure, it gives them a false sense of security.

At a time when seemingly every biotech is promoting the idea of one-and-done therapies and setting prices accordingly these advocates hope companies, too, will be more wary. One of the things Im trying to make them very aware of is the need for lifelong follow-up, said Heather Smith, who runs the SCID Angels for Life foundation. For her, its personal: This summer, her son took part in a clinical trial for a gene therapy in the hope that it would provide the immune protection that his decades-old bone marrow transplant no longer could. My son will be followed for 15 years, she said. But what about after that?

Part of the issue with bone marrow transplants from one person to another is the natural genetic variation between us, particularly in the proteins that help our bodies distinguish its own cells from foreign ones. Receiving cells from someone whose proteins dont match yours could cause a civil war within you. Thats why bone marrow transplants began back in the 1950s with identical twins: Sharing those genes meant increasing the likelihood of harmony between the body and the graft.

But the vast majority of people dont have a protein-matched sibling, let alone an identical twin. So researchers set about figuring out how to transplant bone marrow from a parent to a child in spite of only sharing half of their genes and from a matched unrelated donor to a stranger. Like cooks intent on refining recipes to their taste, the doctors who adapted the technique for SCID often did so slightly differently from one another. Over the past 35 years, those idiosyncrasies have hardened into habits. Right now, everybody transplants their patients their way, said Dr. Sung-Yun Pai, an immune deficiency researcher and co-director of the gene therapy program at Boston Childrens Hospital.

Perhaps the most vociferous controversy has been about whether to use chemotherapy to wipe out the existing stem cells within a recipients bone marrow to make room for the donors. The doctors who do use chemo before a transplant might prescribe different doses; others forego it entirely.

The arguments were sound on both sides. On the one hand, the toxic drugs could clean out the niches within our bone and increase the chances that the donors cells take root. On the other, these chemicals could hamper growth, brain development, and fertility, could make an infant who was already sick even sicker, and could increase the likelihood of certain cancers later in life. Its like being exposed to a bunch of X-rays and sunlight, or other DNA-damaging agents, Pai explained.

Because SCID is so rare the most common subtype is thought to occur in 1 out of every 50,000 to 100,000 newborns and because every hospital was doing transplants slightly differently, it was hard for physicians to systematically study what was working best. But even early on, they could tell that some of the infants whod gotten no chemo were developing incomplete immune systems. They didnt produce their own B cells, for instance, and so needed regular injections of antibodies collected from other peoples blood.

In healthy infants, stem cells migrate from the crevices of the skeleton to an organ in the chest called the thymus, where theyre trained to become T cells. In these infants, the T cell counts grew after transplant but it wasnt necessarily because the sludge was securely taking hold in the niches of their bones. Rather, immunologists say, the donors progenitor cells were only transient. Some were able to head toward the thymus for schooling. Some graduated and started fighting off infections. But as those populations were depleted with age, there werent robust reserves of stem cells in the bone marrow that could arrive to produce more. To Pai, its like trying to fill a kindergarten class in a neighborhood where no ones having babies.

You and I continue to have a slow trickle of new T cells coming out, said Dr. Harry Malech, a senior investigator at the National Institutes of Health, who sits on the board of a gene therapy company, Orchard Therapeutics (ORTX), but does not receive any financial compensation. Instead of a torrent becoming slower, in these patients it goes from a trickle to practically nothing.

Thats why immunity starts to wane in kids like Ray Ballard. To many immunologists, it isnt a surprise, though they still arent sure why chemo-less transplants last longer for some of these kids than others. They can also understand how some families and clinicians might have viewed this treatment as a lifetime fix.

As Malech put it, If I said to you, Your child, instead of dying in infancy, will likely get to adulthood, go to school, have a normal life, you might think the word cure in your mind.

Even for parents who knew the protection might not last forever, the failure of a long-ago bone marrow transplant puts them in a bind. If they do nothing, their child will once again be vulnerable to any passing infection, which could prove fatal. They can try another round of the same procedure, though booster transplants sometimes come with added complications. Or they can try getting their child into a research trial for gene therapy, which comes with the risks of any experimental treatment.

Some feel an irrational guilt when the bone marrow they donated to their child stops functioning. Its your cells, and if it doesnt work, you failed them, said Ballard, who lives in Clifton, Va., about a 40-minute drive from Washington, D.C. Her son Ray had already had three transplants as a child. When his immune system started to fail again in early adulthood, gene therapy at the NIH seemed like the only reasonable choice.

That would involve researchers removing cells from his bone marrow, using an engineered virus as a kind of molecular syringe to slip in a healthy copy of the gene in which he had a defect, and then threading these corrected cells back into his veins a bone marrow transplant to himself. But preparing a virus can be tricky, and there were delays.

Meanwhile, Rays condition was getting worse. His norovirus was preventing him from absorbing much nutrition, and as Ballard put it, his bone structure was just crumbling at that point. His doctors told her he had the skeleton of an 85-year-old.

He died this past February, at 25 years old. One friend got his birth and death dates tattooed onto her shoulder. Another painted a portrait of him for Ballard, in which his arms are crossed, his lips pressed together in a wry smile.

At Boston Childrens, Pai is now helping to lead a randomized trial to better understand what dose of chemo works best for SCID patients receiving transplants. Over the last decade or so, she, Malech, and many other clinicians have also teamed up to track the long-term results of immune deficient patients whove received someone elses bone marrow.

Pai is hopeful that knowing about the phenomenon of waning immunity will give gene therapies a better shot at becoming a durable fix. They probably have a better chance of achieving a one-time, lifelong cure, but its never wrong to be humble, she said. Only after decades more and hundreds or thousands of patients will we know for sure.

Patient advocates point out that even then, these patients will still have the capacity of passing on their SCID-causing gene to future generations, and so the word cure is overly optimistic. Thats why I like the word remission, said Smith. That still gives you the hope. If you were given a cancer diagnosis, you wouldnt go through treatment and then just forget about it for the rest of your life.

As Boyle put it, Weve seen the promise and then weve seen the reality. Everyone who is looking at a transformational therapy should be optimistic, but also realistic, and not assume that this is truly one and done. (Boyles foundation has received financial support from Orchard Therapeutics, which is developing a gene therapy for a form of SCID.)

To Amy Saada, of South Windsor, Conn., that isnt theoretical. Her son Adam is now 12, and the immunity from the bone marrow transplant he got as a baby is wearing off. He isnt yet sick, but his parents know they need to decide between gene therapy or another transplant soon. She has a very clear memory of how long and uncertain the recovery from treatment felt. In some ways, she wishes she didnt know quite as much as she does; that way, she would feel less trepidation about what lies ahead.

Your heart kind of sinks, she said. Youve already been through it once, and it was hell. Its harder the second time.

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Waning treatment is a warning for all 'one-and-done' therapies - STAT - STAT

Bone Marrow Stem Cells Comments Off on Waning treatment is a warning for all ‘one-and-done’ therapies – STAT – STAT | December 19th, 2019

SEATTLE--(BUSINESS WIRE)--According to Coherent Market Insights, the global bone graft and substitutes market is estimated to be valued at US$ 3,046.7 million in 2019, and is expected to exhibit a CAGR of 5.5% during the forecast period (2019-2027).

Key Trends and Analysis of the Global Bone Graft and Substitutes Market:

Key players in the market are focusing on receiving product approvals for bone grafts and bone graft substitutes are expected to fuel growth of the global bone graft and substitutes market over the forecast period. For instance, in December 2016, CoreBone, an Israel-based company manufacturing bone grafts from corals received approval from European Medicines Agency (EMA) for use this product in Europe, which is expected to generate a significant revenue for the region through its sales.

Request your Sample PDF copy @ https://www.coherentmarketinsights.com/insight/request-sample/1050

Moreover, adoption of inorganic growth strategies by major key players is expected to boost the market growth over the forecast period. For instance, in February 2019, Orthofix Medical acquired Options Medical, LLC, a medical device distributor based in Florida, U.S. The acquisition aims to enhance the sales force. Moreover, in 2017, LifeNet Health acquired Austria-based tissue bank- AlloTiss Gemeinntzige Gewebebank GmbH. The acquisition enabled LifeNet Health to establish training and distribution center in Vienna, Austria to support the use of allograft in Europe.

Furthermore, rising road accidents and injuries is expected to propel the market growth over the forecast period. For instance, in 2018, as per the World Health Organization (WHO) estimation, around 1.35 million people are reported to die each year due to road traffic crashes, globally.

Among regions, Asia Pacific is expected to show significant growth in the global bone graft and substitutes market, owing to increasing road accidents in the region. For instance, according to the World Health Organization report in 2013, Asia Pacific region reported around 153,000 fatalities due to road accidents or around 400 deaths each day. It also stated that road traffic death rate in South-East Asia region was 17.0 per 100,000 population, compared to the global rate of 17.4, where there was considerable variation seen within the region ranging from 3.5 in the Maldives to 36.2 in Thailand in 2015.

Key Market Takeaways:

Buy this Report (Single User License) @ https://www.coherentmarketinsights.com/insight/buy-now/1050

Market Segmentation:

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Global Bone Graft and Substitutes Market to Surpass US$ 4673.5 Million by 2027 Coherent Market Insights - Business Wire

Bone Marrow Stem Cells Comments Off on Global Bone Graft and Substitutes Market to Surpass US$ 4673.5 Million by 2027 Coherent Market Insights – Business Wire | December 19th, 2019

For its promising investigational therapeutic approach to neurodegenerative diseases, including progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics is theBuzz of BIO 2020 winnerin the Public Therapeutic Biotech category.

The Buzz of BIO contest identifies U.S. companies with groundbreaking, early-stage potential to improve lives. The event also is anopportunity to make investor connections that could take products to the next phase.

Ten biotechnology companies are nominated in each of the three categories of Buzz of BIO: Public Therapeutic Biotech, Private Therapeutic Biotech, and Diagnostics and Beyond. In the Public Therapeutic Biotech category that BrainStorm won, nominated companies must be actively developing a publicly traded human treatment intended for review by theU.S. Food and Drug Administration.

As a developer of autologous cellular therapies for debilitating neurodegenerative diseases, BrainStorm is testing its investigational therapy,NurOwn, in progressive MS patients, for whom treatment options are limited.

The therapy is based on patients own bone marrow-derived mesenchymal stem cells that are engineered to secrete growth factors. Such factors are thought to protect nerves from damage, promote the repair of myelin (the protective coat of neurons that is destroyed in MS), and ultimately slow or stabilize disease progression.

BrainStorms current open-label Phase 2 clinical study (NCT03799718) is enrolling up to 20 adults with either secondary progressive or primary progressive MS at three U.S. sites:theKeck School of Medicine of USC, the Stanford School of Medicine, and theCleveland Clinic. After undergoing a bone marrow aspiration to collect cells, each participant will receive three intrathecal (injected into the spinal cord) NurOwn cell transplants within 16 weeks, and will be tracked for at least another 12 weeks to assess safety and effectiveness. Contact information for the trial centers is available here.

Thanks to everyone who voted for BrainStorm during the Buzz of BIO competition,Chaim Lebovits, BrainStorm president and CEO, said in a press release.

As the winner of the contest, BrainStorm also was invited to givea presentation at theBio CEO & Investor Conference, to be held Feb. 1011 in New York City.

The entire management team at BrainStorm was very pleased with the results of this competition, and we look forward to presenting to an audience of accredited investors who may benefit from the companys story, said Lebovits. We thank the BIO[Biotechnology Innovation Organization] team for singling out BrainStorms NurOwn as a key technology with the potential to improve lives.

NurOwn cells also are being tested in a Phase 3 trial (NCT03280056) in patients with amyotrophic lateral sclerosis (ALS).

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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BrainStorm Cell Therapeutics Wins 2020 'Buzz of BIO' Award - Multiple Sclerosis News Today

Bone Marrow Stem Cells Comments Off on BrainStorm Cell Therapeutics Wins 2020 ‘Buzz of BIO’ Award – Multiple Sclerosis News Today | December 19th, 2019

Plinabulin Protects Bone Marrow from Chemotherapy-Induced Deficiencies with a Differentiated Yet Complimentary Mechanism to G-CSF for CIN Prevention

NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the peer reviewed journal Cancer Chemotherapy and Pharmacology published a report on the unique mechanism of action (MoA) of the Companys lead asset, Plinabulin. The report demonstrates that Plinabulin can successfully treat chemotherapy-induced neutropenia (CIN) caused by multiple chemotherapies. In addition, Plinabulin has positive effects on bone marrow cells, with a mechanism distinct from G-CSF-based therapies, the current standard of care for CIN.

The paper, titled, Plinabulin ameliorates neutropenia induced by multiple chemotherapies through a mechanism distinct from GCSF therapies, reports on Plinabulins ability to reduce neutropenia induced by docetaxel, cyclophosphamide or doxorubicin chemotherapy, without affecting bone marrow or blood G-CSF levels. The results support Plinabulins clinical testing as a non-G-CSF-based treatment for CIN associated with chemotherapies of different mechanisms.

Importantly, our nonclinical data also demonstrated the positive effects of Plinabulin on bone marrow cellsconsistent with clinical results recently reported in human subjects at ASH 2019which demonstrate that Plinabulin increases the number of circulating white blood cells positive for CD34 (a marker for hematopoietic stem and progenitor cells, or HSPC, in humans), as well as the finding that Plinabulin protects bone marrow lymphoid and myeloid progenitor cells from the negative effects of chemotherapy, said James R. Tonra, Senior Vice President, Preclinical Development at BeyondSpring and the lead author of the article. A therapy that increases bone marrow HSPC count also has the potential to alleviate chemotherapy-induced deficiencies (chemo-assault) in multiple mature cell populations within the hematopoietic system. In line with this potential, Plinabulin alleviates docetaxel-induced thrombocytopenia, as well as neutropenia, in NSCLC patients.

By combining these two molecules Plinabulin and G-CSF patients get the benefit of these different and additive mechanisms of action that can work together to create a new standard of care in preventing CIN, added Dr. Ramon Mohanlal, BeyondSprings Chief Medical Officer and Executive Vice President, Research and Development. CIN not only puts chemotherapy patients at increased risk of infections and mortality, but also can deny them from receiving the best anti-cancer care, as CIN typically leads to a decrease / delay or discontinuation of otherwise effective chemotherapy. A chemotherapy dose reduction of just 15 percent can reduce long-term survival by as much as 50 percent. Plinabulin has also demonstrated anti-cancer activity in studies to date, and the addition of Plinabulin to G-CSF potentially offers the distinct advantage of better protection against CIN versus G-CSF alone, avoidance of G-CSF-related bone pain and improving outcomes.

The article is authored by BeyondSprings James Tonra, Ph.D.; Ramon Mohanlal, MD, Ph.D.; G. Kenneth Lloyd, Ph.D., Chief Scientific Officer; and Lan Huang, Ph.D., Co-Founder, Chairman and CEO.

About BeyondSpring BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies. BeyondSprings lead asset, Plinabulin, is in two Phase 3 global clinical programs, one as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and the other in the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to Plinabulin, including three immuno-oncology assets and a drug discovery platform using the ubiquitination degradation pathway. The Company also has a seasoned management team with many years of experience bringing drugs to the global market.

About PlinabulinPlinabulin, BeyondSprings lead asset, is a marine-derived small molecule that sequesters tubulin heterodimers in a differentiated manner from other agents in this class. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The anticancer benefits of Plinabulin have been associated with positive effects on antigen presenting cells and T-cell activation, as well as to the direct killing of cancer cells. Plinabulins CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Story continues

About Chemotherapy-Induced Neutropenia (CIN)CIN is a common, often severe side effect that cancer patients who are undergoing treatment experience involving the destruction of neutrophils, which are a type of white blood cell and a patients first line of defense against infections. The current standard of care for CIN prevention is G-CSF monotherapy, which has serious limitations as described in its product information summary.

As many as 90 percent of patients who receive high-risk chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia [Lee et al., Annals of Surgical treatment and research 94(5): 223-228 (2018)]. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial / fungal infections and sepsis, which can require hospitalization and be fatal. Grade 4 CIN can have an adverse effect on chemotherapy administration and is usually considered a significant predictor of low relative dose intensity (RDI), dose delays and dose reductions [Lalami Y, Critical Reviews in Oncology / Hematology, 120: 163 179 (2017)]. Even a 15 percent chemotherapy dose reduction can reduce long-term survival by as much as 50 percent [Bonadonna, Med Oncol 29:14951501 (2012)].

Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain [Moore et al., Annals of Pharmacotherapy 51(9): 797-803 (2017)]. Twenty-five percent of patients also report that the pain is severe. The National Comprehensive Cancer Network (NCCN) guidelines require that patients with grade 3 or 4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care [Lalami et al., Critical Reviews in Oncology / Hematology 120: 163-179 (2017)].

Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements that are not historical facts. Words such as will, expect, anticipate, plan, believe, design, may, future, estimate, predict, potential, suggest, objective, goal, or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSprings current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Certain of the statements made in this press release are forward-looking, such as those, among others, relating to BeyondSprings expectations regarding the completion of the proposed offering. No assurance can be given that the offering discussed above will be consummated, or that the net proceeds of the offering will be used as indicated. Consummation of the offering and the application of the net proceeds of the offering are subject to numerous possible events, factors and conditions, many of which are beyond the control of the Company and not all of which are known to it, including, without limitation, market conditions and those described under the heading Risk Factors in the Company's Annual Report on Form 20-F for the year ended December 31, 2018, as updated by those risk factors included in the Companys subsequent filings under the Securities Exchange Act of 1934, as amended, which can be accessed at the SEC's website at http://www.sec.gov. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, the anticipated amount needed to finance the Companys future operations, unexpected results of clinical trials, delays or denial in regulatory approval process, its expectations regarding the potential safety, efficacy or clinical utility of its product candidates, or additional competition in the market, and other risk factors referred to in BeyondSprings current Form 20-F on file with the SEC. The forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts:Caitlin Kasunich / Dave SchemeliaKCSA Strategic Communications212.896.1241 / 212.896.1242ckasunich@kcsa.com / dschemelia@kcsa.com

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BeyondSpring Publishes Report on Benefits and Mechanism of Plinabulin in Reducing Neutropenia with Multiple Chemotherapies - Yahoo Finance

Bone Marrow Stem Cells Comments Off on BeyondSpring Publishes Report on Benefits and Mechanism of Plinabulin in Reducing Neutropenia with Multiple Chemotherapies – Yahoo Finance | December 19th, 2019

https://www.projectlifemovement.org/impact/https://www.projectlifemovement.org/impact/

Our Impact

The Project to Save Lives Leukemia, Sickle Cell anemia and other diseases can often be cured with a bone marrow transplant. However, African American patients with leukemia and Sickle Cell have only a 23% chance of finding a bone marrow match on the National Registry. For mixed race patients the chance of finding a match is even lower. Conversely, African American and mixed race patients with leukemia or Sickle Cell have a 77% or more chance of dying if the only treatment that will save their lives is a bone marrow match and transplant. Compare this to the 41% chance of finding a match for Asian or Pacific Islanders, 46% for Hispanics or Latinos, 57% for American Indian and Alaska Natives, and 77%f for whites. The only reason for these discrepancies is the lack of bone marrow donors from the African American and mixed race communities. The solution to this problem is simple. We can save lives by having more African American and mixed race bone marrow donors, and providing supportservices to African American and mixed race children and adults in need of bone marrow transplants. This is the mission of The Project to Save Lives.

Doctors also use bone marrow transplants to treat aplastic anemia, autoimmune diseases (including scleroderma and multiple sclerosis), Hodgkin lymphoma, immune deficiency disorders, inborn errors of metabolism, non-hodkin lympohma, myelodysplastic syndrome, myeleproliferative neoplasms, multiple myeloma, myelofibrosis.

Thousands of patients with these diseases will need a bone marrow transplant to survive. Given the lack of African American and mixed race donors, the shortage of diverse donors costs lives. With ethnicity being the key to a perfect match between donor and recipient, we can change the odds only by increasing donors from the African American and mixed race communities. Increase the donors and the odds of finding matching donors will increase. You could save a life and become a hero by being a donor, and being a donor can be as simple as donating blood platelets.

ligible donors must be 18-44 years of age and in general good health. Donors must be willing and committed to donate to any patient they might match. Registration involves completing a consent form and a simple cheek swab test. Cheek swabbing is free. This can be done at an actual drive or by requesting a kit online to complete your swab. This places you on the Be The Match Registry for anyone you might match. While the current method of registration is digital The Project to Save Lives is working on a method of registration for those not equipped to register digitally.

If you match a patient in need, there are two ways to donate. The patients doctor chooses the method of donation that is best for the patient. 80% of the time Peripheral blood stem cell (PBSC) donation is used. This is the method of collecting blood-forming cells for transplants. The same blood forming cells that are found in marrow are also found in the circulating (peripheral) blood. PBSC is a non-surgical procedure, called apheresis. The donation takes place at an experienced facility that participates in PBSC collections. For 5 days leading up to donation you will be given injections of a drug called filgrastim to increase the number of cells in your bloodstream that are used for transplant. Some of your blood is then removed through a needle in one arm and passed through a machine that separates out the blood-forming cells. The remaining blood is returned to you through the other arm. The other 20% of marrow donations take place in a hospital under general anesthesia. Doctors use a needle to withdraw liquid marrow from the back of your pelvic bone. Donors feel no pain or discomfort during the donation. The procedure is out-patient. There is small discomfort to save a life. Further, donors never pay for donating and are never paid to donate. The amount of cells donated will not weaken your immune system. Most donors are back to their usual routine in a few days and your marrow naturally replaces itself within 4-6 weeks.

Some believe that donors are usually found in their family. This is not true. 70% of patients do not have a matching donor in the family. Adding more registry members increases the ethnic diversity of the registry which increases the variety of tissue types available, which helps more people of ethnicity and ethnic diversity find the match they need. Additionally, members of the LGBTQ+ community can join the registry and donate. The African American and mixed race communities need members who are committed to helping save a life. This means being willing to donate to anyone in need. If you are called as a potential match for a patient, your commitment means that youre willing to take up to 20-30 hours spread over 4-6 weeks to: attend an information session, attend appointments, and donate. You are also committing to keeping your contact information up-to-date so that the registry can find you to quickly get a blood sample for further match testing.

There are many myths about bone marrow donation:MYTH: Donating is very painful.FACT: Donating is less painful than you think.MYTH: Donating involves opening up or removing bones.FACT: This is not true. Most blood stem cell donors (80%) give PBSC a process similar to platelet donation. This is a non-surgical, out-patient procedure and no bone is removed. The donorreceives a drug for 5 days to increase the number of cells in the bloodstream. The cells are then collected during donation. The donor may experience head or muscle aches that disappearshortly after the donation, and are typically back to their normal routine in 1 to 2 days.

The other procedure (20%) is a surgical, out-patient procedure that takes place in a hospital operating room. While the donor is under anesthesia, the doctors collect marrow from the back ofthe donors pelvic bone. After donation, donors may feel soreness in the lower back. Donors are typically back to their normal routine in 2 to 7 days.MYTH: Donating is dangerous.FACT: There are few risks to donating.MYTH: Donating takes a long time.FACT: It doesnt take long to save someones life.MYTH: Donating is expensive and you need medical insurance.FACT: Donating is absolutely free to the donor.MYTH: Sharing your personal information and DNA is risky.FACT: Be the Match and HIPPA will protect your privacy andconfidentiality.MYTH: Asking about a donors ethnic background is racist.FACT: Ethnic background is an important factor for matching donors to patients. When it comes to matching human leukocyte antigen (HLA) types,a patients ethnic background is important inpredicting the likelihood or finding a match. This is because HLA markers used in matching are inherited.MYTH: Gay men cannot join or donate.FACT: Gay men and others in the LGBTQ+ community CAN join the registry and donate.MYTH: Be the Match discriminates against people age 45+.FACT: Age guidelines protect the safety of the donor and provide the best possible outcome for the patient. They are not meant to discriminate.

More Important Facts:1. Every 3 minutes, someone is diagnosed with a blood cancer like Leukemia. For many of these and other patients with diseases like Sickle Cell anemia, a marrow transplant is the only lifesaving treatment-their only chance for a cure.2. Every year, more than 14,000 patients are diagnosed with life-threatening blood cancerslike leukemia and lymphomaor other diseases for which a marrow or cord blood transplant from an unrelated donor may be their best or only hope of a cure.3. 70% of all patients who need a transplant do not have a matched donor in their family. They depend on Be The Match Registry to find an unrelated donor or cord blood unit.4. Approximately 70 % of transplants facilitated by the National Marrow Donor Program are for patients diagnosed with leukemia or lymphoma.5. Every 10 minutes, someone dies from a blood cancer. Thats more than six people each hour, or 148 people each day.6. More than 70 diseases can be treated & cured by an unrelated donor transplant.7. Leukemia causes more deaths than any other cancer among children and young adults under the age of 20.8. Be The Match Registry works tirelessly on behalf of patients in need of a life-saving transplant. Through successful partnerships with organizations, more volunteer donors step forward, more funding becomes available to support critical outreach and more advances are made in the science of transplants. We all have the power to heal, the power to save a life. Take the first step.9. African Americans and people of mixed race are particularly at risk of dying due to inability to find a match.10. Due to significant medical achievements in recent decades, survival rates are higher than ever for bone marrow and PBSC transplants. There are Health Benefits of Diets That Increase Bone Marrow in Donors. There are health benefits to diets that will increase your Red Blood Count to make you a more valuable donor. The Be the Match registry can give you information on what to eat to increase your Red Blood Count which will, in turn, greatly improve you health.

Join the Be The Match RegistryBe the Match is the largest, most diverse registry of potential marrow donors and cord blood units in the world. Be the Match offers one-on-one support, education and guidance before, during and after transplants. But first a marrow match must be found. And there are many patients in need of a donor. The ICLA DA SILVA FOUNDATION, INC. is A Recruitment Center for the Be the Match Registry. The Icla da Silva Foundation is the largest recruitment center for the Be The Match Registry in the United States. It recruits over 38,000 new potential bone marrow donors every year, with a strong focus on minority communities. The Icla da Silva Foundation was established in 1992, in memory of the 13-year-old Brazilian girl named Icla da Silva. After two years of fighting leukemia, Icla passed away in New York City, where she came hoping to get her life saving treatment: a bone marrow transplant. The young girl never found a matching donor.

With offices across the United States and Puerto Rico, the Foundation is continuously expanding its efforts in providing assistance and hope to thousands of families in the United States and all over the world. The mission of the Icla da Silva Foundation is to save lives by recruiting bone marrow donors and providing support services to children and adults with leukemia and other diseases treatable by marrow transplants. The Icla da Silva Foundation is a nonprofit organization under section 501(c) 3 of the IRS Code. Eligible donors must be 18-44 years of age and in general good health. Be willing and committed to donate to any patient that you might match. Registration involves completing a consent form and a simple cheek swab test. This places you on the Be The Match Registry for anyone you might match. You can contact the ICLA/Be the Match organization through the following:

https://bethematch.org/support-thecause/donate-bone-marrow/donation-faqs/. You can also contact The Project to

Save a Life through its two community volunteers: John-Michael Lawrence atlawrencejohnmichael9@gmail.com and Rhoda London at diversitydonordrive@aol.com.

What You Can Do Besides Being a Donor:If you are not able to donate or are younger than 18 or older than 44, you can:1. Host an actual cheek swabbing drive in you place of worship, school, business organization;2. Publicize a digital drive in any of the above on Facebook or any other social media;3. Share the information with other groups,family and friends;4. Make a financial donation in honor of your own good health or in honor of your recovery from and illness. Since swabbing and medical expenses are free, financial donations go to support analyzing the swabs and medical expenses for the donor and recipient;5. For a PHYSICAL Drive, register online at Join.Bethematch.org/JaxDonors for information and videos on how to hold a drive. Please join the effort, you can save a life.

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The Project to Save Lives Free Press of Jacksonville - Jacksonville Free Press

Bone Marrow Stem Cells Comments Off on The Project to Save Lives Free Press of Jacksonville – Jacksonville Free Press | December 19th, 2019

Many of us biologists conduct fieldwork in diverse places, from Alaska to the tropics, from aiming to understand how microbes are responding to climate change in the boreal soils to learning about life history strategies and co-evolutionary arms races of bats, their ectoparasitic flies, and the ectoparasitic fungi living on those flies.

The days before fieldwork tend to be hectic: make a checklist to make sure you have everything you need, think about a plan B (and a plan C, just in case), anticipate drawbacks and plan on how to address them, and the list goes on and on. The day comes. You make it to your field site, you collect the samples you want, obtain the data you need, everything works out just like planned, and you make it back to the lab safe, on time, and without going over your planned budget. This is how it should be, but it never really goes like that.

Fieldwork is one of the most exciting experiences about doing research. It is also, in many cases, high-risk. During fieldwork, many things can go wrong, and most of those things cannot be helped. We cannot control the appearances of massive puddles in the middle of the road, critically damaging our transportation vehicles. We cannot control the thunderstorm that makes our study organisms disappear when we finally arrive at a remote field site after hours of climbing a mud-covered mountain.

Sadly, this is not always the case for threats to our integrity as human beings, and we, as a scientific community, have done far too little to address this problem. People from underrepresented groups in the sciences such as people of color, women, and those who identify as LGBTQIA+ or gender nonconforming often are at higher risk of suffering abuse during fieldwork. This comes in the form of sexual harassment, sexual abuse, discrimination, and intimidation. Scientists who have experienced abuse often fear talking about it because they are traumatized and because they fear retaliation and backlash, especially if the perpetrators of abuse are colleagues or superiors advisers and people at higher career stage.

In Spring 2018, we carried out an anonymous survey to collect testimonies of what scientists, specifically from the LGBTQIA+ community, experience during fieldwork. The idea for such a survey sprouted from concerns that sexual orientation or gender identity may play an unwanted or unwarranted role in peoples professional career. Especially during fieldwork, when Diversity and Inclusion Offices from our university campuses are far away, LGBTQIA+ researchers are exposed to people who may not agree with their sexual orientation or who do not understand why he may want to be addressed as they.

Responses revealed experiences ranging from discrimination to situations that made researchers decide to no longer perform fieldwork outside of safe places. This adds a whole new level to fieldwork stress, namely having to evaluate sites for their tolerance towards LGBTQIA+. In one story from fieldwork, men voiced discomfort because an openly gay man would share a room with them while, simultaneously, women felt uncomfortable due to the possibility of having to share a room with someone from the opposite sex. Another survey respondent described that they were fearful to carry out fieldwork in places that are recognized for their homophobic culture. These experiences leave people feeling isolated and rejected.

We present a few strategies that we can instill in STEM fields to avoid cases like these:

1) INFORM PEOPLE ABOUT LGBTQIA+. Erase any misinformation that may exist. For example, a gay man is not a threat to the sexuality of cisgender males. Institutions can facilitate trainings on diversity and inclusiveness and provide information on the LGBTQIA+ community to eliminate negative stereotypes.

2) HAVE SUFFICIENT FUNDING AVAILABLE FOR FIELDWORK. Although sometimes it's unavoidable to share rooms due to limited budget or space, if there is the possibility to do so, provide individual lodging for people traveling to fieldwork or conferences. Especially for those who ask for it.

3) DEVELOP AN EMERGENCY PROTOCOL. As a lab, department, or institution, develop a protocol that scientists can follow as a response to experiencing a threat to their integrity. Protocols like this should be part of a broader departmental or university-wide mission statement about equity in field work. The bar has been set high by this example of a mission statement written by University of California Irvine professor Kathleen Treseder.

4) AVOID INTOLERANT AREAS. It is important to note that this does not only apply to countries like Niger and Tunisia where discriminatory laws expose LGBTQIA+ individuals to the risk of death penalty. It also applies close to home, in the USA, where there is an ongoing debate about public restrooms and which one transgender people and people who identify as gender-nonconforming should use.

5) IMPLEMENT A ZERO-TOLERANCE POLICY. Inform everyone in your lab, department and institution that there is a zero-tolerance policy regarding abuse. A code of conduct with expected versus unaccepted behavior and practices should always be made available through trainings and in field stations.

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Questions about biology, sex, and gender? We have answers - Massive Science

Cardiac Stem Cells Comments Off on Questions about biology, sex, and gender? We have answers – Massive Science | December 19th, 2019

Gurugram/New Delhi: In a ground-breaking procedure, Haematologists and Bone Marrow Transplant specialists successfully treated Anurag Mishra, a 47-year-old man from New Delhi, suffering from Multiple Sclerosis (MS) from the past seven years.

Multiple sclerosis (MS) is a life-long condition, known to reduce life-expectancy. MS affects the brain and spinal cord that leads to serious disabilities.

The most common symptoms of MS include loss of sensation and balance, restricted arm or leg movement and vision loss in one or both the eyes.

Mishra, who was bedridden earlier, is back to his normal routine life, was diagnosed with MS an autoimmune neurodegenerative disease, where the body's own defence system starts attacking its nervous system, without any specific reason

Dr Rahul Bhargava, Director, Department of Clinical Hematology & Bone Marrow Transplant, Fortis Hospital in Gurugram with his team performed autologous bone marrow transplant where they used Mishra's stem cells for transplant, thereby reducing the chances of rejection and infections.

"In an autologous BMT procedure, the healthy stem cells from the patient are taken out and preserved. Chemotherapy is then administered to reset the body's immunity and then the stem cells are injected back to rescue the person from the side effects of chemotherapy," said Bhargava.

After the surgery, the patient is kept under isolation for a few months to ensure he/she does not contract any infection. In this case, when Mr Anurag approached us, he was entirely dependent on others for his basic needs. But within six months after the treatment, he is back on his legs and is carrying on with his normal life," Bhargava added.

According to the patient, the attacks are sudden and may affect any part of your body, limiting your abilities.

"Extreme pain and disabilities this disease gave, made me very scary and depressing. I think I am very lucky to get to know about Dr Rahul Bhargava and team, who cured me miraculously," Mishra said.

"Too much delay in the procedure can considerably affect the clinical outcomes. In the case of Mr Anurag, recovery is 90 per cent, which means he received the treatment within recovery time-frame," Dr Bhargava said.

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Delhi: 47-year-old successfully treated with bone marrow transplant - ETHealthworld.com

Spinal Cord Stem Cells Comments Off on Delhi: 47-year-old successfully treated with bone marrow transplant – ETHealthworld.com | December 19th, 2019

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 and tumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successful stem cell therapy treatment 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.

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 Predicted to Accelerate the Growth by 2017-2025 - Industry Mirror

Spinal Cord Stem Cells Comments Off on Stem Cell Assay Market Predicted to Accelerate the Growth by 2017-2025 – Industry Mirror | December 19th, 2019

LONDON--(BUSINESS WIRE)--Technavio has been monitoring the global allogeneic stem cells market and the market is poised to grow by USD 1.24 billion during 2020-2024 at a CAGR of over 12% during the forecast period. Request Free Sample Pages

Read the 131-page research report with TOC on "Allogeneic Stem Cells Market Analysis Report by geography (Asia, Europe, North America, and ROW), by application (regenerative therapy and drug discovery and development), and segment forecasts, 2020-2024".

https://www.technavio.com/report/allogeneic-stem-cells-market-industry-analysis

The new product approvals and special drug designations are anticipated to boost the growth of the market. Based on the application, the allogeneic stem cells market has been segmented into regenerative therapy and drug discovery and development. Manufacturers are increasingly emphasizing innovations and improvisation in the development of regenerative therapies. Many of the regenerative therapeutic candidates have obtained approval for clinical trials in the US, Europe, and APAC due to the efficacy of allogeneic stem cell therapeutics. This is encouraging market players to launch new product lines to stimulate the overall product demand for stem or regenerative therapy using allogeneic stem cell therapeutics and provide better options for their customers. Thus, new product approvals are expected to drive market growth during the forecast period.

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Major Five Allogeneic Stem Cells Market Companies:

Biosolution Co. Ltd.

Biosolution Co. Ltd. is headquartered in South Korea (Republic of Korea) and operates the business under its Unified business segment. The company offers an allogeneic keratinocyte spread medication, Keraheal-Allo, that promotes skin regeneration.

Cynata Therapeutics Ltd.

Cynata Therapeutics Ltd. is engaged in the discovery, development, licensing, manufacturing, marketing, distribution, and sales of innovative therapeutics for the treatment of various diseases. The company provides a mesenchymal stem cell product, Cymerus, which is used to treat graft-versus-host disease.

JCR Pharmaceuticals Co. Ltd.

JCR Pharmaceuticals Co. Ltd. is headquartered in Japan and operates under two business segments, namely Pharmaceuticals, and Medical Devices and Laboratory Equipment. The company offers a regenerative medical product, TEMCELL HS Injection, which uses human mesenchymal stem cells for the treatment of acute graft-versus-host disease.

Lineage Cell Therapeutics Inc.

Lineage Cell Therapeutics Inc. is headquartered in the US and offers products through its Unified business segment. The company provides OpRegen, which is currently being tested in a Phase I/IIa clinical trial. This product is intended for the treatment of dry AMD.

MEDIPOST Co. Ltd.

MEDIPOST Co. Ltd. is headquartered in South Korea (Republic of Korea) and offers products through its Unified business segment. The company provides an allogeneic umbilical cord blood-derived mesenchymal stem cell drug, CARTISTEM, which is used for the treatment of knee cartilage defects.

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Global Allogeneic Stem Cells Market 2020-2024 | Evolving Opportunities with Biosolution Co. Ltd. and Cynata Therapeutics Ltd. | Technavio - Business...

Skin Stem Cells Comments Off on Global Allogeneic Stem Cells Market 2020-2024 | Evolving Opportunities with Biosolution Co. Ltd. and Cynata Therapeutics Ltd. | Technavio – Business… | December 18th, 2019

Specializing in innovative cosmetic applications for the face, eyes, and body, Dr. Zamora is a leader in minimally invasive treatments.

DENVER (PRWEB) December 18, 2019

Dr. Jack Zamora, a renowned face expert in Denver, Colorado has joined the esteemed Haute Beauty network.

The Haute Beauty Network, well known for its exclusive and luxurious lifestyle publication Haute Living is privileged to present Dr. Jack Zamora as a face expert and our newest addition to the Haute Beauty members-only network.

Haute Beauty offers a prominent collective of leading doctors. The invitation-only exclusive publication maintains elite as ever, with only two doctors in every market. This partnership allows Haute Beauty to connect its affluent readers with industry-leading aesthetic surgeons located in their area.

ABOUT DR. ZAMORADr. Jack Zamora is an oculofacial plastic surgeon, and a pioneer in plasma treatments and stem cell technology. Specializing in innovative cosmetic applications for the face, eyes, and body, Dr. Zamora is a leader in minimally invasive treatments. Graduating from Tulane University in New Orleans, he received a doctorate degree in medicine and completed his internship at Boston Medical Center (internal medicine), his residency at Boston University (ophthalmology department), and completed his fellowship at Boston University (ophthalmology and oculoplastics).

Dr. Zamora is the medical director of several locations throughout Colorado offering select surgical and non-surgical facial refinement, skin rejuvenation, and body sculpting services. Known for exceptional patient care and state-of-the-art procedures that achieve natural-looking results with as little downtime as possible, Dr. Zamora and his team work with each patient to tailor a combination of treatments for long-term results.

As the creator of J-Plazty, Dr. Zamora has received national and international attention for his revolutionary technique. J-Plazty is a minimally invasive procedure that uses Renuvion plasma energy sub-dermally to instantly tighten and rejuvenate skin anywhere on the face and body without large incisions, downtime, or the complications of traditional surgery. As an authority on skin tightening applications, Dr. Zamora has seen remarkable results with plasma and often combines it with other radiofrequency (RF) modalities for superior rejuvenation. Utilizing his plasma techniques with micro and macro-needling radiofrequency (RF), Dr. Zamora is seeing unparalleled skin shrinkage as well as tightening of extremely delicate tissue allowing for long-term improvement with less downtime

In an effort to improve the outcome of aesthetic procedures, Dr. Zamora has partnered with Vitro BioPharma to develop the worlds first ultra pure cosmetic stem cell serum, InfiniVive MD, to be used topically by plastic surgeons, cosmetic surgeons, and aestheticians throughout the United States. InfiniVive MD is the highest quality cGMP-grade cosmetic stem cell serum containing ultra pure mesenchymal stem cells and exosomes. InfiniVive MD is to be used with ablative and non- ablative lasers, plasma energy technologies, and microneedling radiofrequency. The serum provides an unprecedented improvement in fine lines and wrinkles, helps reduce the signs of aging, and helps promote accelerated healing.

Being an international trainer for J-Plazty, Apyx Medical, and Bausch Health Companies Inc., and a luminary for AMP Medical, Lutronic Medical, and Syneron ELOS, Dr. Zamora offers his expertise to physicians from around the globe. He is a regular speaker and consultant, has been featured on The Doctors TV Show, and has written on the techniques and parameters of soft tissue coagulation and subcutaneous neck skin plasma tightening. Valuing continued education, Dr. Zamora created the Jack Zamora MD Aesthetic Institute, which offers advanced aesthetic training to medical professionals and licensed aestheticians.

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Dr. Jack Zamora Partners with the Exclusive Haute Beauty Network - PR Web

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No longer must you wait until the National Enquirer gets a hot tip from an anonymous source that "various celebrities" are getting facials made from liquefied cells of a baby's foreskin to learn about the latest skincare trends on the market. In 2020, we suggest a slightly more discerning approach: get your forecast on the biggest treatments and ingredients to try in the new year straight from the experts.

To be clear, that doesn't mean the future of skin care is any less exciting or innovative. (As dermatologist Matthew Elias, MD, put it: "2020 is going to be a banner year for skin care.") There will be blood, personalization, and a slight tweak to the lip filler movement you've been seeing everywhere of late. TDLR? The next phase of skincare trends will be anything but boring, and we asked a handful of derms to break down which ones you should be most excited about in 2020.

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These 5 Skincare Trends Are the Wave of the Future, and You'll See 'Em Everywhere in 2020 - POPSUGAR

Skin Stem Cells Comments Off on These 5 Skincare Trends Are the Wave of the Future, and You’ll See ‘Em Everywhere in 2020 – POPSUGAR | December 18th, 2019

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The 2010s will go down in history as a decade of many newsworthy health-related stories, many of which were not good news -- Ebola, measles, antibiotic resistance. But in the years since 2010 there were also many promising discoveries in medicine, life-saving drugs approved, and great strides taken addressing national health crises. Some of these stories will have lasting effects for generations to come.

24/7 Tempo reviewed multiple news archives and dozens of articles published since 2010 to select 15 of the most positive health news stories that made headlines.

Some of the most talked about stories over the last few years have influenced health guidelines, treatment of serious disease, and even government policy.

Reports of significant research developments in the treatment and prevention of chronic and other conditions gave hope to millions of Americans. Some of the good news broke as recently as just a few months ago these are the 15 biggest health topics of 2019.

Click here for 15 of the best health news over the last decade.

CT scans in high risk patients can reduce overall lung cancer mortality

Year: 2011

Category: Diseases

The tremendous effort by researchers and health institutions to develop a cure for cancer over the decades since the legislation for the War on Cancer was enacted in 1971 will likely continue. Any good news on developments are worth noting. The 2011 National Lung Screening Trial showed a reduction in lung cancer mortality of 20% in high risk patients receiving low-dose CT (LDCT) compared to chest X-ray. The CDC recommends that people at high risk of developing lung cancer -- heavy smokers, people who have smoked as recently as 15 years, and people who are 55 years or older -- undergo annual LDCT scans because of potential risks.

In 2016, there were 218,229 new cases of lung cancer, and 148,869 people died from the disease in the United States, according to the CDC. The American Cancer Society estimates 142,670 deaths from lung cancer in 2019. A major reason for the disease's high mortality rate is that the tumor does not typically cause symptoms until it spreads, making early screening especially crucial to improving survival rates.

Blame SUVs: These 9 cars will be killed in 2020

Pass the ketchup, hold the beef: Americans crave Impossible Burger, Beyond Meat in 2020

Melanoma drug approved

Year: 2011

Category: Treatment

After more than a decade of no new potential drugs for melanoma, the deadliest form of skin cancer, the FDA approved vemurafenib, sold under the brand name Zelboraf, in 2011 for patients with metastatic melanoma with the BRAF(V600E) mutation or for those who have tumors that cannot be surgically removed.

Zelboraf was seen as a major development because it can improve melanoma patients' quality of life -- the drug is a simple pill taken twice a day -- and it may extend survival rate. In a trial, the length of time melanoma patients who received Zelboraf lived without the cancer getting worse was almost double the length of patients who did not take the drug.

Since 2011 several drugs have been approved to treat melanoma, and survival rates of this deadly cancer have improved.

Gene editing is now possible

Year: 2012

Category: Technology

Gene editing is the process of changing an organisms DNA. After decades of research around the world, scientists made a major breakthrough with the discovery of clustered repeats of DNA sequences, known as CRISPR.

First described in 2012, CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, is the basis for potentially world-changing gene editing technology, or, as some might say, DNA hacking. It may be used to develop treatments for a range of diseases, including cancer and genetic disorders. In 2015, CRISPR was successfully used for the first time to save a life. Two baby girls, 11-month and a 16-month-old, received gene editing treatment to help them fight leukemia.

While the gene-altering tool is bringing revolutionary change to health fields, it has also raised serious ethical concerns. Misuses and inadvertently harmful uses of CRISPR include those for creating designer babies, and causing environmental ripple effects by eliminating disease-spreading insects.

FDA says trans fat should not be considered 'safe'

Year: 2013

Category: Eating

Trans fats, or partially hydrogenated oils, have been widely used for years, most notably in fast foods. Trans fats can raise the levels of "bad" LDL cholesterol, lower the levels of good-for-you HDL cholesterol, and increase the risk of heart disease, the No. 1 killer in the United States. And now they are on their way out.

In 2013, the FDA officially announced trans fats should not be considered safe in human food. In 2015, the agency gave food manufacturers three years to phase out the use of trans fats in their products. The deadline was June 18, 2018, although the FDA granted a one-year extension in the use of artificial trans fats in some cases. The ban will be fully implemented in Jan. 1, 2020.

HIV prevention pill

Year: 2014

Category: Diseases

About 50,000 Americans are diagnosed with HIV every year, according to the CDC. Despite advancements in treatment and years of research into the infection, HIV does not have a cure. In 2014, the CDC issued new guidelines that recommend a pill to people at high risk of HIV as a prevention method. High risk people include gay or bisexual men, injection drug users, and women with an HIV+ partner.

The agency said that the pill, sold under the brand name Truvada, may lower the risk by as much as 90% when taken consistently. Truvada has been used to treat HIV since 2012 when the FDA approved the drug. Truvada contains tenofovir and emtricitabine, which when used in combination with other antiviral medication may keep the HIV virus from establishing a permanent infection.

A new way to treat cavities

Year: 2015

Category: Treatment

In 2015, the FDA approved a painless new way to treat tooth decay called silver diamine fluoride (SDF). It's a liquid that is applied directly to cavities to stop the decay. The FDA gave it a "breakthrough therapy designation" two years later.

As a non-invasive and fairly cheap method (it costs about $20-$25 per tooth), SDF treatment, which must be prescribed by a dentist, can save people a lot of money. About 91% of American adults have dental decay, and about 27% have untreated tooth decay, according to the CDC. Tooth decay is common among kids as well -- it's the most common chronic disease in children between 6 and 11 years of age.

3D printing of human organs

Year: 2015

Category: Technology

3D printing technology has improved considerably over the past few years. (Today, low-budget 3D printers are available for anyone who can spare $100.) The technology has advanced so much that producing fully functional replacement organs from a person's own cells seems like a not-so-distant possibility. Scientists at Harvard's Wyss Institute have grown a heart tissue that beats just like a normal human heart.

Production for treatment is still years away, however. The technique, called sacrificial writing into functional tissue (SWIFT), has not even been tested on mice yet. But if it works, it can be used to print other organs, too, potentially saving the lives of thousands of people who are waiting for an organ transplant.

Immunotherapy and cancer

Year: 2016

Category: Treatment

Cancer immunotherapy was named the 2016 Advance of the Year by the American Society of Clinical Oncology. The therapy is designed to support and boost the immune systems response to cancer cells, rather than targeting the cancer itself. One of the most successful immunotherapies so far is the checkpoint inhibition. It makes the immune response stronger by keeping immune cells activated, which does not normally happen when a person has cancer.

It may take decades until immunotherapy could replace the current standards in cancer treatment of surgery, chemotherapy, and radiation, but currently hundreds of immunotherapy drugs are being tested in clinical trials on people.

Some benefits of immunotherapy include fewer side effects than radiation or chemotherapy, lower risk of relapse, and making other cancer treatments more effective.

Opioid crisis recognized as national public health emergency

Year: 2017

Category: Public health

Every day over 130 people in the United States die from opioid overdose, including pain medication, heroin, and synthetic opioids such as fentanyl, according to the National Institutes of Health. In 2017, President Donald Trump declared the opioid crisis a national public health emergency, giving hope that the federal government's involvement could help fight the worst drug crisis in U.S. history.

The official designation removed certain administrative requirements for accessing federal funds to fight the epidemic, including the use of taxpayers' money to make addiction treatments and naloxone, a life-saving medication that can reverse an opioid overdose, drug, more accessible.

The Department of Health and Human Services has renewed the opioid crisis' status as a national emergency several times since 2017. Money has been used to speed up a survey on whether and how often doctors prescribe opioids and help launch anti-addiction programs quicker, according to the a 2018 report by the Government Accountability Office.

Early-stage Alzheimer's treatment

Year: 2019

Category: Diseases

Currently, there is no treatment for Alzheimer's disease, the sixth leading cause of death in the United States. Pharmaceutical companies and universities have tried to tackle different aspects of the neurodegenerative disorder, but to no avail. Until just a few months ago.

Biogen, a biotechnology company, announced in October 2019 it would ask the FDA to approve its Aducanumab drug as first treatment for early Alzheimer's disease. The company said that patients in the early stages of the disease who were treated with a high dose of the drug experienced significant improvements in memory, orientation, and language. If Aducanumab is approved, it will be one of a handful of drugs approved to treat the disease.

Smoking rates at all-time low

Year: 2018

Category: Habits

The short and long-term health problems smoking causes have been well-documented for decades. Today cigarette smoking among U.S. adults is at an all-time low -- 13.7% in 2018, according to the CDC.

While smoking regular cigarettes is down, smoking e-cigarettes is on the rise. About 37% of 12th graders reported vaping in 2018, compared with 28% in 2017. A recent Gallup survey found that 20% of 18- to 29-year-olds vape regularly, more than twice the national average for all age groups.

There has been a recent outbreak of lung injury associated with the use of e-cigarettes. At least 47 deaths and 2,290 lung injuries have been confirmed by the CDC as a result of vaping as of Nov. 20, 2019. The agency has identified vitamin E acetate, an additive in some THC-containing e-cigarettes, as the likely cause for the lung injuries.

Cystic fibrosis treatment approved by FDA

Year: 2019

Category: Treatment

About 30,000 Americans live with cystic fibrosis, a fairly common genetic disease that affects the lungs and other organs, limiting one's ability to breathe as the disease progresses. About 1,000 new cases are diagnosed every year.

The FDA approved in 2019 what it called a "new breakthrough" therapy to treat the condition. The medication, sold under the name Trikafta, is available to patients who are 12 years or older and have the F508del mutation, the most common cystic fibrosis mutation. It is found in 90% of the people living with the disease. The treatment can increase the life expectancy of patients, which is now around 44 years.

Second HIV patient goes into remission

Year: 2019

Category: Diseases

A second person since HIV was identified in the 1980s has been said to be in sustained remission. The patient, who was treated in London, has not been given antiretroviral therapy for 18 months, and the virus has remained undetectable. The good news comes more than a decade after the Berlin patient, known as the first person to have been cured from the infection. Both patients received a stem cell transplant.

HIV, the virus that causes AIDS, is one of the most serious global health challenges. Almost 38 million people live with HIV worldwide, according to the World Health Organization. Just over 60% are receiving treatment.

Blood test detects breast cancer 5 years early

Year: 2019

Category: Diagnoses

Even though deaths from breast cancer have declined, the disease remains the second leading cause of cancer death among women in the United States, according to the CDC. More than 40,000 women die from it a year.

Improved rates of early detection have helped drive up survival rates. A recent British study offers hope that the condition could now be detected five years before there are any clinical signs of it. The new method is a blood test that identifies the body's immune response to antigens produced by tumor cells. The test may be available in clinics in about five years.

Finding a cure for arthritis

Year: 2019

Category: Treatment

2019 has been an exciting year in the field of health technology and scientific research. In addition to such technological developments as organ printing and gene editing, recent research has shown promise for a cure for arthritis. Millions of people suffering from joint inflammation -- from osteoarthritis, for example, which is the most common form of arthritis -- may be helped.

A recent study published in the Science Advances journal has found that "cartilage in human joints can repair itself [...] to regenerate limbs." The body was previously believed to be unable to do so. People have a molecule that helps with joint tissue repair, and that molecule is more active in ankles and less active in knees and hips. The findings can help develop treatments that may prevent, slow, or even reverse arthritis.

24/7 Wall Street is a USA TODAY content partner offering financial news and commentary. Its content is produced independently of USA TODAY.

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This was the best health news over the last decade - USA TODAY

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LONDON, Dec. 18, 2019 /PRNewswire/ --GSK today announced positive headline results for intravenous (IV) Benlysta (belimumab) in the largest controlled phase 3 study in active lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE) which can lead to end-stage kidney disease.

The Efficacy and Safety of Belimumab in Patients with Active Lupus Nephritis (BLISS-LN) study, involving 448 patients, met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) over two years when treated with belimumab plus standard therapy compared to placebo plus standard therapy in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311).

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Lupus nephritis is one of the most common and serious complications of SLE, occurring in up to 60% of adult patients. The results of the BLISS-LN study show that Benlysta could make a clinically meaningful improvement to the lives of these patients who currently have limited treatment options."

Dr Richard Furie,Chief of the Division of Rheumatology and Professor at the Feinstein Institutes atNorthwell Health and Lead Investigator of BLISS-LN said: "My journey with Benlysta began nearly twenty years ago when we performed the very first clinical research trial in lupus patients. To see it culminate in a successful phase 3 lupus nephritis study is a key achievement as the inadequate response of our patients with kidney disease to conventional treatment has long been an area in need of major improvement."

Belimumab also demonstrated statistical significance compared to placebo across all four major secondary endpoints: Complete Renal Response (CRR) after two years (the most stringent measure of renal response), Ordinal Renal Response (ORR) after two years, PERR after one year, and the time to death or renal-related event. In BLISS-LN, safety results for patients treated with belimumab were generally comparable to patients treated with placebo plus standard therapy. The safety results are consistent with the known profile of belimumab.

Benlysta is currently not recommended for use in severe active lupus nephritis anywhere in the world because it has not been previously evaluated in these patients. Based on these positive phase 3 data, GSK plans to progress regulatory submissions in the first half of 2020 to seek an update to the prescribing information.

The full results will be submitted for future presentation at upcoming scientific meetings and in peer-reviewed publications.

About lupus nephritisSystemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation, which can lead to end-stage kidney disease. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.1,2 Manifestations of LN include proteinuria, elevations in serum creatinine, and the presence of urinary sediment.

About BLISS-LNBLISS-LN,which enrolled 448 adult patients, was a phase 3, 104-week, randomised, double-blind, placebo-controlled post-approval commitment study to evaluate the efficacy and safety of IV belimumab 10 mg/kg plus standard therapy (mycophenolate mofentil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active lupus nephritis. Active lupus nephritis was confirmed by kidney biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, and clinically active kidney disease.

The primary endpoint PERR was defined as estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73m2 or no decrease in eGFR from pre-flare of > 20%; and urinary protein:creatinine ratio (uPCR) 0.7; and not a treatment failure. The most stringent secondary endpoint CRR was defined as eGFR is no more than 10% below the pre-flare value or within normal range; and uPCR < 0.5; and not a treatment failure. ORR was defined as complete, partial or no response.

About Benlysta (belimumab)Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

The current US and EU indication for Benlysta are summarised below:

In the US, "Benlysta is indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations."

Full US prescribing information including Medication Guide is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG.PDF

In the EU, "Benlysta is indicated as "add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy."

The Precaution and Warnings for Benlysta includes information that "Benlysta has not been studied in the following adult and paediatric patient groups, and is not recommended: severe active central nervous system lupus; severe active lupus nephritis; HIV; a history of, or current, hepatitis B or C; hypogammaglobulinaenia (IgG < 400mg/dl) or IgA deficiency (IgA < 10 mg/dl); a history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant."

The EU Summary of Product Characteristics for Benlysta is available on: http://www.ema.europa.eu

Benlysta is available as an intravenous and a subcutaneous formulation. The Benlysta subcutaneous formulation is not approved for use in children.

GSK's commitment to immunologyGSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and paediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.

Important Safety Information for belimumabPlease consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab)

Contraindications:Previous anaphylaxis with BENLYSTA.

Warnings and precautions: Not recommended in adult and paediatric groups with severe active central nervous system lupus, severe active lupus nephritis, HIV, history of/current hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) and patients with a history of major organ transplant or hematopoietic stem/cell/marrow transplant or renal transplant.

Mortality:In adult intravenous (IV) clinical trials, death occurred in 0.8% of patients treated with BENLYSTA and in 0.4% of patients receiving placebo; etiologies included infection, cardiovascular disease, and suicide. In the adult SC clinical trial, death occurred in 0.5% of patients receiving BENLYSTA and in 0.7% of patients receiving placebo; infection was the most common cause of death.

Serious Infections:Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections in adults treated with BENLYSTA IV included pneumonia, urinary tract infection, cellulitis, and bronchitis. Use caution in patients with severe or chronic infections, and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML):Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (Including Anaphylaxis):Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.

Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.

Infusion Reactions:Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality:In clinical trials, psychiatric disorders (depression, suicidal ideation and behavior) were reported more frequently in patients receiving BENLYSTA than placebo. In adult trials, psychiatric events reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. Before adding BENLYSTA, physicians should assess patients' risk of depression and suicide and monitor them during treatment. Instruct patients to contact their HCP if they experience new/worsening depression, suicidal thoughts, or other mood changes.

Malignancy:The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies or IV Cyclophosphamide:BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide.

Adverse Reactions:The most common serious adverse reactions in adults were serious infections: BENLYSTA IV 6.0% (placebo 5.2%), some of which were fatal. Adverse reactions occurring in 3% of adults and 1% more than placebo: nausea 15% (12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9% (7%); bronchitis 9% (5%); insomnia 7% (5%); pain in extremity 6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%); cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3% (1%).

Adverse reactions in pediatric patients aged 5 years receiving BENLYSTA IV were consistent with those observed in adults.

The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.

Pregnancy and lactation:Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for 4 months after the final treatment.

Lactation:No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric Use:The safety and effectiveness have not been established for BENLYSTA IV in patients <5 years of age and for BENLYSTA SC in patients <18 years of age.

Black/African American Patients:In clinical trials there have been mixed results regarding how well BENLYSTA works in this patient population. Consider risks and benefits when prescribing BENLYSTA.

About GSK GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit http://www.gsk.com.

Trademarks are owned by or licensed to the GSK group of companies.

References

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Simon Steel

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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

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Cell Processing Technologies Market: Introduction

Cell processing involves a series of activities ranging from cells collection from donor, cell extraction till the storage, and cells distribution to receiver for cell therapy. Cell processing includes various processes of cell collection, cell isolation, cell analysis, cell expansion, washing and concentration, preservation, and distribution.

Cell therapy refers to administering of living whole cells in a patient for treating a disease. Cells origin can be from the same individual, known as autologous source or from another individual, known as allogeneic source. For cell therapy, different types of cells can be used, including hematopoietic stem cells, skeletal muscle cells, embryonic stem cells, neural cells, and mesenchymal cells. Cell therapy is used for the treatment of autoimmune diseases, cancers, infectious and urinary diseases, repairmen of spinal cord injuries, rebuilding damaged cartilage in joints, improvement of a weakened immune system, and aiding patients with neurological disorders.

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Key Drivers of Global Cell Processing Technologies MarketIncrease in demand for cell therapy, as it is the only curative treatment for several diseases, such as autoimmune disease, cancer, and neural disease. This factor is responsible for growth of the global cell processing technologies market.

There is a rise in prevalence of various diseases, such as cancer, immune diseases, neurological disorders, cardiovascular disease, etc. According to the National Cancer Institute, in 2016, there were an estimated 15.5 million cancer survivors in the U.S. The number of cancer survivors is anticipated to increase to 20.3 million by 2026.

Personalized medicines or precision medicines with advanced treatments such as gene therapy and cell therapy are witnessing a surge in their adoption, as most of the key biotechnology and pharmaceutical players are heavily investing in these technologies

Government investments in cell-based researches, rise in the number of GMP-certified production facilities, and increase in clinical trials of various diseases are key factors propelling the growth of the global cell processing technologies market

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Key Restraints of Global Cell Processing Technologies Market

Cell processing is a complex procedure with high probabilities of failure. Thus, its complexity and accuracy demand technologically advanced and high-tech infrastructure, along with a skilled operating staff. These incur high infrastructural and operating costs, which limit its adoption on a large scale.

High operating cost also leads to high cell therapy cost to patients. However, at present, the cell therapy is approved for a limited number of conditions, which further limits the usage of cell processing technologies and services

Equipment Segment of Cell Processing Technologies Market to Witness Strong Growth

Complexity in cell processing steps and accuracy required for procedure has led to the development of advanced automated cell processing systems. Key players have been heavily investing in the development of advanced cell processing systems. Advancements in software for managing these systems are projected to expand the application areas for cell processing units.

In May 2018, GE Healthcare introduced the Sefia S-2000 cell processing system, which is advanced than its predecessor Sefia S-1000 cell processing system. This advanced system was developed with focus on chimeric antigen receptor (CAR) T-cell therapy.

Investments in CAR-T and other cell and gene therapy products are projected to drive the adoption of cell processing equipment. As the installed base for cell processing systems is projected to surge, the demand for consumables is likely to grow during the forecast period.

Oncology is projected to be the most promising application area of cell processing technology, considering high investments and ongoing research in cell therapies for cancer treatment and high investment made by key biotechnology and pharmaceutical companies in this area.

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