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

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

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

Data Supporting Approval

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

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

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

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

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

About KEYTRUDA (pembrolizumab) Injection, 100 mg

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

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

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

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

Head and Neck Squamous Cell Cancer

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

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

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

Classical Hodgkin Lymphoma

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

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High (MSI-H) Cancer

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

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

Gastric Cancer

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

Esophageal Cancer

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

Cervical Cancer

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

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

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

Cutaneous Squamous Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

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

Other Immune-Mediated Adverse Reactions

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

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

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

Infusion-Related Reactions

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Segmental Analysis

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

Global Autologous Stem Cell Based Therapies Market Segment By Type:

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

Global Autologous Stem Cell Based Therapies Market Segment By Application:

, Neurodegenerative Disorders, Autoimmune Diseases, Cardiovascular Diseases

Competitive Landscape

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

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

Key questions answered in the report:

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TOC

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Stem cells are biological cells which have the ability to distinguish into specialized cells, which are capable of cell division through mitosis. Amniotic fluid stem cells are a collective mixture of stem cells obtained from amniotic tissues and fluid. Amniotic fluid is clear, slightly yellowish liquid which surrounds the fetus during pregnancy and is discarded as medical waste during caesarean section deliveries. Amniotic fluid is a source of valuable biological material which includes stem cells which can be potentially used in cell therapy and regenerative therapies. Amniotic fluid stem cells can be developed into a different type of tissues such as cartilage, skin, cardiac nerves, bone, and muscles. Amniotic fluid stem cells are able to find the damaged joint caused by rheumatoid arthritis and differentiate tissues which are damaged. Medical conditions where no drug is able to lessen the symptoms and begin the healing process are the major target for amniotic fluid stem cell therapy. Amniotic fluid stem cells therapy is a solution to those patients who do not want to undergo surgery. Amniotic fluid has a high concentration of stem cells, cytokines, proteins and other important components. Amniotic fluid stem cell therapy is safe and effective treatment which contain growth factor helps to stimulate tissue growth, naturally reduce inflammation. Amniotic fluid also contains hyaluronic acid which acts as a lubricant and promotes cartilage growth.

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With increasing technological advancement in the healthcare, amniotic fluid stem cell therapy has more advantage over the other therapy. Amniotic fluid stem cell therapy eliminates the chances of surgery and organs are regenerated, without causing any damage. These are some of the factors driving the growth of amniotic fluid stem cell therapy market over the forecast period. Increasing prevalence of chronic diseases which can be treated with the amniotic fluid stem cell therapy propel the market growth for amniotic fluid stem cell therapy, globally. Increasing funding by the government in research and development of stem cell therapy may drive the amniotic fluid stem cell therapy market growth. But, high procedure cost, difficulties in collecting the amniotic fluid and lack of reimbursement policies hinder the growth of amniotic fluid stem cell therapy market.

The global amniotic fluid stem cell therapy market is segmented on basis of treatment, application, end user and geography:

Some of the key players operating in global amniotic fluid stem cell therapy market are Stem Shot, Provia Laboratories LLC, Thermo Fisher Scientific Inc. Mesoblast Ltd., Roslin Cells, Regeneus Ltd. etc. among others.

Rapid technological advancement in healthcare, and favorable results of the amniotic fluid stem cells therapy will increase the market for amniotic fluid stem cell therapy over the forecast period. Increasing public-private investment for stem cells in managing disease and improving healthcare infrastructure are expected to propel the growth of the amniotic fluid stem cell therapy market.

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However, on the basis of geography, global Amniotic Fluid Stem Cell Therapy Market is segmented into six key regionsviz. North America, Latin America, Europe, Asia Pacific Excluding China, China and Middle East & Africa. North America captured the largest shares in global Amniotic Fluid Stem Cell Therapy Market and is projected to continue over the forecast period owing to technological advancement in the healthcare and growing awareness among the population towards the new research and development in the stem cell therapy. Europe is expected to account for the second largest revenue share in the amniotic fluid stem cell therapy market. The Asia Pacific is anticipated to have rapid growth in near future owing to increasing healthcare set up and improving healthcare expenditure. Latin America and the Middle East and Africa account for slow growth in the market of amniotic fluid stem cell therapy due to lack of medical facilities and technical knowledge.

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Rapid Unit Sales of Amniotic Fluid Stem Cell Therapy to Account for Incremental Revenues in the Global Market through the COVID 19 Crisis Period -...

Cardiac Stem Cells Comments Off on Rapid Unit Sales of Amniotic Fluid Stem Cell Therapy to Account for Incremental Revenues in the Global Market through the COVID 19 Crisis Period -… | June 23rd, 2020

By Chris Kocher

June 18, 2020

The Thomas J. Watson School of Engineering and Applied Sciences Department of Biomedical Engineering has earned nearly $4 million in grants from 201820 (as of March 2020). Associate Professor Sha Jin alone received three grants totaling $1.2 million for her diabetes research. Funding agencies include the National Institutes of Health, the National Science Foundation and the National Institute of Standards and Technology.

Guy German

ASSOCIATE PROFESSOR

RESEARCH TOPIC: HUMAN SKIN

THE GOAL: Understanding how different factors can cause the mechanical properties of our skin to change. The human body has many barriers, and skin is arguably the most important, protecting us from the external environment. When skin becomes broken or ruptured, that barrier is lost. It can be caused by surgical incisions, penetrating trauma, diseases that cause lesions and chapping from cold environments. German explores how bacteria can degrade integrity; the effects of chronological- and photo-aging; and how to create bio-inspired materials that control crack propagation and the movement of fluids on their surfaces.

Tracy Hookway

ASSISTANT PROFESSOR

RESEARCH TOPIC: HEART CELLS

THE GOAL: Turning stem cells into functioning cardiac cells.

The human heart does not have the ability to repair itself after heart attacks or similar cardiac events. By merging the fields of stem-cell biology, tissue engineering and cardiovascular physiology, Hookway is trying to make models of cardiovascular tissue in a Petri dish that are more similar to what is in our bodies. One challenge is that the heart is not one cell type; in fact, it is multiple types of cells working together to achieve function.

Sha Jin

ASSOCIATE PROFESSOR

RESEARCH TOPIC: DIABETES

THE GOAL: Generating pancreatic tissue from stem cells.

One experimental treatment for diabetes currently in clinical trials through the U.S. Food and Drug Administration is islet transplantation, but there are fewer donors than needed. Human-induced pluripotent stem cells cells that can self-renew by dividing could offer a renewable source for islets, but they remain a challenge because of limited knowledge about how islets form. Jins lab has been working to direct stem cells to differentiate and mature into pancreatic islet organoids using a variety of approaches; when successful, these islets would be transplanted into humans.

Ahyeon Koh

ASSISTANT PROFESSOR

RESEARCH TOPIC: HUMAN SWEAT

THE GOAL: Utilizing sweat to generate electricity for flexible biosensors and to monitor stress levels.

Kohs research aims to give us real-time information about how our bodies are functioning, such as for glucose monitoring, wound care and post-surgery cardiac health. She is currently working with other Binghamton professors on two microfluidic systems that can collect and use the sweat that our body produces. One of them will have sweat-eating bacteria that will power biosensors, and the other will monitor stress levels by measuring the amounts of the steroid hormone cortisol that are secreted.

Gretchen Mahler

ASSOCIATE PROFESSOR

RESEARCH TOPIC: ORGAN-ON-A-CHIP

THE GOAL: Creating 3D microfluidic cell-culture chips that simulate the mechanics and physiological response of organs and tissues.

Mahlers current research which has applications for cardiovascular disease and cancer focuses on how disruptions in a tissues mechanical or chemical environment can lead to disease initiation and progression. She currently is working with three other professors two from Watson, one from Harpur College of Arts and Sciences on a National Science Foundation-funded study of calcific aortic valve disease, and she also is interested in how food additives alter gastrointestinal health.

Kaiming Ye

PROFESSOR AND DEPARTMENT CHAIR

RESEARCH TOPIC: CANCER VACCINE

THE GOAL: Developing a vaccine that will slow or halt the growth of future tumors.Yes research is targeting the protein CD47, which is part of the membrane that covers human cells. It also sends a dont eat me signal to a bodys immune system normally a good thing, but a problem when cells become cancerous. In a 2019 study using mice treated with their experimental vaccine, Ye and his co-investigators found a two-fold reduction in tumor growth rates and five-fold reduction in size in the tumors that did form.

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Biomedicals big year: Grants fund research on skin, heart cells, cancer and more - Binghamton University

Cardiac Stem Cells Comments Off on Biomedicals big year: Grants fund research on skin, heart cells, cancer and more – Binghamton University | June 19th, 2020

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

Know the Growth Opportunities in Emerging Markets

Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

Order this Report TOC for Detailed Statistics

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

About TMR Research:

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Therapy Market Analysis On Trends & Need 2025 3w Market News Reports - 3rd Watch News

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Analysis On Trends & Need 2025 3w Market News Reports – 3rd Watch News | June 19th, 2020

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

Know the Growth Opportunities in Emerging Markets

Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

Order this Report TOC for Detailed Statistics

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

About TMR Research:

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

Read this article:
Stem Cell Therapy Market to Incur Rapid Extension During 2025 - Owned

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market to Incur Rapid Extension During 2025 – Owned | June 17th, 2020

Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases. Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

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Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market.

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Some of the major companies operating in the global cardiac rhythm management market areMedtronic, Abbott Laboratories, Boston Scientific, St. Jude Medical, Altera, and Sorin.Other companies with significant presence in the global cardiac rhythm management market include

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Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 - The Canton Independent Sentinel

Cardiac Stem Cells Comments Off on Cardiac Rhythm Management Market to Witness Rapid Increase in Consumption During 2015 2021 – The Canton Independent Sentinel | June 17th, 2020

With a full devotion and dedication this superior GLOBAL HUMAN EMBRYONIC STEM CELL MARKET report is presented to the clients that extend their reach to success. Market parameters covered in this advertising report can be listed as market definition, currency and pricing, market segmentation, market overview, premium insights, key insights and company profile of the key market players. Each parameter included in this GLOBAL HUMAN EMBRYONIC STEM CELL MARKET business research report is again explored deeply for the better and actionable market insights. Geographical scope of the products is also carried out comprehensively for the major global areas which helps define strategies for the product distribution in those areas.

TheGlobal Human Embryonic Stem Cell Marketstudy with 100+ market data Tables, Pie Chat, Graphs & Figures is now released by Data Bridge Market Research. The report presents a complete assessment of the Market covering future trend, current growth factors, attentive opinions, facts, and industry validated market data forecast till 2026. Delivering the key insights pertaining to this industry, the report provides an in-depth analysis of the latest trends, present and future business scenario, market size and share ofMajor Players such as Arizona Board of Regents, STEMCELL Technologies Inc, Cellular Engineering Technologies, CellGenix GmbH, PromoCell GmbH, Lonza, Kite Pharma, Takeda Pharmaceutical Company Limited, BrainStorm Cell Limited., CELGENE CORPORATION, Osiris Therapeutics,Inc, U.S. Stem Cell, Inc and amny More

Global human embryonic stem cell market estimated to register a healthy CAGR of 10.5% in the forecast period of 2019 to 2026. The imminent market report contains data for historic year 2017, the base year of calculation is 2018 and the forecast period is 2019 to 2026. The growth of the market can be attributed to the increase in tissue engineering process.

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Market Dynamics:

Set of qualitative information that includes PESTEL Analysis, PORTER Five Forces Model, Value Chain Analysis and Macro Economic factors, Regulatory Framework along with Industry Background and Overview.

Global Human Embryonic Stem Cell Market By Type (Totipotent Stem Cells, Pluripotent Stem Cells, Unipotent Stem Cells), Application (Regenerative Medicine, Stem Cell Biology Research, Tissue Engineering, Toxicology Testing), End User (Research, Clinical Trials, Others), Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa) Industry Trends and Forecast to 2026

Global Human Embryonic Stem Cell Research Methodology

Data Bridge Market Research presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.The data thus presented is comprehensive, reliable, and the result of extensive research, both primary and secondary. The analysts have presented the various facets of the market with a particular focus on identifying the key industry influencers.

Major Drivers and Restraints of the Human Embryonic Stem Cell Industry

Complete report is available (TOC) @https://www.databridgemarketresearch.com/toc/?dbmr=global-human-embryonic-stem-cell-market

The titled segments and sub-section of the market are illuminated below:

By Type

By Application

By End User

Top Players in the Market are:

Some of the major companies functioning in global human embryonic stem cell market are Arizona Board of Regents, STEMCELL Technologies Inc, Cellular Engineering Technologies, CellGenix GmbH, PromoCell GmbH, Lonza, Kite Pharma, Takeda Pharmaceutical Company Limited, BrainStorm Cell Limited., CELGENE CORPORATION, Osiris Therapeutics,Inc, U.S. Stem Cell, Inc, Waisman Biomanufacturing, Caladrius, Pfizer Inc., Thermo Fisher Scientific, Merck KGaA, Novo Nordisk A/S, Johnson & Johnson Services, Inc and SA Biosciences Corporation among others.

How will the report help new companies to plan their investments in the Human Embryonic Stem Cell market?

The Human Embryonic Stem Cell market research report classifies the competitive spectrum of this industry in elaborate detail. The study claims that the competitive reach spans the companies of.

The report also mentions about the details such as the overall remuneration, product sales figures, pricing trends, gross margins, etc.

Information about the sales & distribution area alongside the details of the company, such as company overview, buyer portfolio, product specifications, etc., are provided in the study.

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Some of the Major Highlights of TOC covers:

Chapter 1: Methodology & Scope

Definition and forecast parameters

Methodology and forecast parameters

Data Sources

Chapter 2: Executive Summary

Business trends

Regional trends

Product trends

End-use trends

Chapter 3: Human Embryonic Stem Cell Industry Insights

Industry segmentation

Industry landscape

Vendor matrix

Technological and innovation landscape

Chapter 4: Human Embryonic Stem Cell Market, By Region

Chapter 5: Company Profile

Business Overview

Financial Data

Product Landscape

Strategic Outlook

SWOT Analysis

Thanks for reading this article, you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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GLOBAL HUMAN EMBRYONIC STEM CELL MARKET Analysis 2020 With COVID 19 Impact Analysis| Leading Players, Industry Updates, Future Growth, Business...

Cardiac Stem Cells Comments Off on GLOBAL HUMAN EMBRYONIC STEM CELL MARKET Analysis 2020 With COVID 19 Impact Analysis| Leading Players, Industry Updates, Future Growth, Business… | June 17th, 2020

Lately, there has been rising awareness among people regarding the therapeutic potential of stem cells for disease management. This is one of the key factors contributing to growth of the global stem cell therapy market.

Further, identification of new stem cell lines, research and development of genome based cell analysis techniques, and investment inflow for processing and banking of stem cell are some of the significant factors augmenting expansion rate of the global stem cell therapy market.

Meanwhile, limitations associated with traditional organ transplantation such as immunosuppression risk, infection risk, and low acceptance rate of organ by body are few features leading to adoption of stem cell therapy. Moreover, high dependency on organ donors for organ transplantation is paving opportunities for growth of the stem cell therapy.

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Moreover, expanding pipeline and development of drugs for new applications are driving growth of the global stem cells market. Growing research activities focused on augmenting the application array of stem cell will also widen the horizon of stem cell market. Researchers are consistently trying to develop novel methods for creating human stem cell in order to comply with the rising demand for stem cell production to be used for disease management.

Development of Advanced Treatment Method Augmenting Market Growth

Lately, various new studies, development of novel therapies, and research projects have come into light in the global stem cell therapy market. Some of these treatment have been by approved by regulatory bodies, while others are still in pipeline for approval of the treatment.

In March 2017, Belgian based biotech firm TiGenix has announced that its latest development- cardiac cell therapy AlloCSC-01 has reached in its phase I/II successfully. It has shown positive results. Meanwhile, the U.S. FDA has also approved the treatment method. If this therapy is well-accepted among the patients, then approximately 1.9 million AMI patients could be treated using the therapy.

Likewise, another significant development that has been witnessed is development novel stem cell based technology for treatment of multiple sclerosis (MS) and similar concerns associated with nervous system. The treatment is developed by Israel-based Kadimastem Ltd. Also, the Latest development has been granted a patent by reputed regulatory body.

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Some of the prominent companies operating in the global stem cell therapy landscape are Anterogen Co. Ltd., RTI Surgical, Osiris Therapeutics Inc., Holostem Terapie Avanzate S.r.l., JCR Pharmaceuticals Co. Ltd., MEDIPOST Co. Ltd., Pharmicell Co. Ltd., and NuVasive Inc.

Some of these firms are following various growth strategies such as mergers and acquisitions, strategic alliances, and collaborations, and product development in order to strengthen their foothold in the global market for stem cell therapy.

Dermatology Segment Holds Prominence in Stem Cell Therapy Market

Stem cell therapy, primarily is a regenerative medicine. It encourages the reparative response of damaged, dysfunctional, or diseases tissue with the help of stem cells and associated derivatives. The treatment method is replacing the conventional transplant methods.

Stem cell therapy method has wide array of application in the field of nervous system treatment, dermatology, bone marrow transplant, multiple sclerosis, osteoarthritis, hearing loss treatment, cerebral palsy, and heart failure. The method aids patients fight leukemia and similar blood related diseases.

Among all, dermatology segment is leading in the global stem cell therapy market. The segment is substantially contributing to growth of the market. Stem cell therapy reduces the after effects of general treatment for burns such as adhesion, infections, and scars among others.

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Meanwhile, rising number of patient suffering from diabetes and increase in trauma surgery cases are anticipated to accelerate the adoption of stem cell therapy in the dermatology segment.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Stem Cell Therapy Market Grows on Back of Growing Awareness Regarding Regenerative Treatment Methods - BioSpace

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Grows on Back of Growing Awareness Regarding Regenerative Treatment Methods – BioSpace | June 16th, 2020

A recent market intelligence study titled Global Autologous Stem Cell Based Therapies Market 2020 by Company, Type and Application, Forecast to 2025 integrated from various professional and trusted sources include a detailed examination of this vertical that is anticipated to accrue substantial proceeds during the predicted timeline from 2020 to 2025. The report provides valuable insights concerning the market size, share, and growth rate of the global Autologous Stem Cell Based Therapies market. The report delivers creditable perceptions with respect to industry size, revenue approximations, sales volume, and more. The research gives knowledge about market players, segments, revenue, profit, restrain, share, size, etc.

The report experts have analyzed various companies to understand the products and/services relevant to the global Autologous Stem Cell Based Therapies market. The report includes information such as gross revenue, production and consumption, average product price, and market shares of key players. The fundamental opinions regarding the market landscape, emerging and high-growth sections of the market, high-growth regions, and market drivers, restraints, and also market chances have collectively included in the report. Many of the circumstances have been taken into consideration to get the best at high-quality data and particular knowledge of the market in upcoming years (forecast) from 2020 to 2025.

DOWNLOAD FREE SAMPLE REPORT: https://www.marketsandresearch.biz/sample-request/67562

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

The report offers a comprehensive understanding of market dynamics across key regions, namely North America (United States, Canada and Mexico), Europe (Germany, France, United Kingdom, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), Middle East & Africa (Saudi Arabia, UAE, Egypt and South Africa).

Product-wise the global market is segmented by spread (regional footprint), and consumption. And, the products include: Embryonic Stem Cell, Resident Cardiac Stem Cells, Umbilical Cord Blood Stem Cells

Basis, separate end-use segments, the market study delves into demand trends for each. The major end-use segments that the market study includes are: Neurodegenerative Disorders, Autoimmune Diseases, Cardiovascular Diseases

Market segment by manufacturers, this report covers: Regeneus, US STEM CELL, INC., Mesoblast, Med cell Europe, Pluristem Therapeutics Inc, Tigenix, Brainstorm Cell Therapeutics

The noted growth rate and proceeds acquired by each region throughout the forecast timeline are also discussed in the report. The study on global Autologous Stem Cell Based Therapies market foresees over the predicted timeline and constitutes additional particulars concerning the market dynamics like the factors influencing industry landscape, challenges, and probable growth opportunities existing in this vertical are presented in the report.

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Global Autologous Stem Cell Based Therapies Market 2020 Growth, Industry Trends, Sales Revenue, Size by Regional Forecast to 2025 - 3rd Watch News

Cardiac Stem Cells Comments Off on Global Autologous Stem Cell Based Therapies Market 2020 Growth, Industry Trends, Sales Revenue, Size by Regional Forecast to 2025 – 3rd Watch News | June 15th, 2020

LOS ANGELES, United States: QY Research has recently published a report, titled COVID-19 Impact on Global Progenitor Cell Product, Market Insights and Forecast to 2026.The market research report is a brilliant, and much-needed resource for companies, stakeholders, and investors interested in the global COVID-19 Impact on Progenitor Cell Product market. It informs readers about key trends and opportunities in the global COVID-19 Impact on Progenitor Cell Product market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global COVID-19 Impact on Progenitor Cell Product market.

Key companies operating in the global COVID-19 Impact on Progenitor Cell Product market include , NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI Progenitor Cell Product

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global COVID-19 Impact on Progenitor Cell Product market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global COVID-19 Impact on Progenitor Cell Product Market Segment By Type:

, Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others Progenitor Cell Product

Global COVID-19 Impact on Progenitor Cell Product Market Segment By Application:

, Medical care, Hospital, Laboratory

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global COVID-19 Impact on Progenitor Cell Product market.

Key companies operating in the global COVID-19 Impact on Progenitor Cell Product market include , NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI Progenitor Cell Product

Key questions answered in the report:

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TOC

1 Study Coverage1.1 Progenitor Cell Product Product Introduction1.2 Market Segments1.3 Key Progenitor Cell Product Manufacturers Covered: Ranking by Revenue1.4 Market by Type1.4.1 Global Progenitor Cell Product Market Size Growth Rate by Type1.4.2 Pancreatic progenitor cells1.4.3 Cardiac Progenitor Cells1.4.4 Intermediate progenitor cells1.4.5 Neural progenitor cells (NPCs)1.4.6 Endothelial progenitor cells (EPC)1.4.7 Others1.5 Market by Application1.5.1 Global Progenitor Cell Product Market Size Growth Rate by Application1.5.2 Medical care1.5.3 Hospital1.5.4 Laboratory1.6 Coronavirus Disease 2019 (Covid-19): Progenitor Cell Product Industry Impact1.6.1 How the Covid-19 is Affecting the Progenitor Cell Product Industry 1.6.1.1 Progenitor Cell Product Business Impact Assessment Covid-19 1.6.1.2 Supply Chain Challenges 1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Progenitor Cell Product Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-19 1.6.3.1 Government Measures to Combat Covid-19 Impact 1.6.3.2 Proposal for Progenitor Cell Product Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Executive Summary2.1 Global Progenitor Cell Product Market Size Estimates and Forecasts2.1.1 Global Progenitor Cell Product Revenue 2015-20262.1.2 Global Progenitor Cell Product Sales 2015-20262.2 Progenitor Cell Product Market Size by Region: 2020 Versus 20262.2.1 Global Progenitor Cell Product Retrospective Market Scenario in Sales by Region: 2015-20202.2.2 Global Progenitor Cell Product Retrospective Market Scenario in Revenue by Region: 2015-2020 3 Global Progenitor Cell Product Competitor Landscape by Players3.1 Progenitor Cell Product Sales by Manufacturers3.1.1 Progenitor Cell Product Sales by Manufacturers (2015-2020)3.1.2 Progenitor Cell Product Sales Market Share by Manufacturers (2015-2020)3.2 Progenitor Cell Product Revenue by Manufacturers3.2.1 Progenitor Cell Product Revenue by Manufacturers (2015-2020)3.2.2 Progenitor Cell Product Revenue Share by Manufacturers (2015-2020)3.2.3 Global Progenitor Cell Product Market Concentration Ratio (CR5 and HHI) (2015-2020)3.2.4 Global Top 10 and Top 5 Companies by Progenitor Cell Product Revenue in 20193.2.5 Global Progenitor Cell Product Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.3 Progenitor Cell Product Price by Manufacturers3.4 Progenitor Cell Product Manufacturing Base Distribution, Product Types3.4.1 Progenitor Cell Product Manufacturers Manufacturing Base Distribution, Headquarters3.4.2 Manufacturers Progenitor Cell Product Product Type3.4.3 Date of International Manufacturers Enter into Progenitor Cell Product Market3.5 Manufacturers Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Progenitor Cell Product Market Size by Type (2015-2020)4.1.1 Global Progenitor Cell Product Sales by Type (2015-2020)4.1.2 Global Progenitor Cell Product Revenue by Type (2015-2020)4.1.3 Progenitor Cell Product Average Selling Price (ASP) by Type (2015-2026)4.2 Global Progenitor Cell Product Market Size Forecast by Type (2021-2026)4.2.1 Global Progenitor Cell Product Sales Forecast by Type (2021-2026)4.2.2 Global Progenitor Cell Product Revenue Forecast by Type (2021-2026)4.2.3 Progenitor Cell Product Average Selling Price (ASP) Forecast by Type (2021-2026)4.3 Global Progenitor Cell Product Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Breakdown Data by Application (2015-2026)5.1 Global Progenitor Cell Product Market Size by Application (2015-2020)5.1.1 Global Progenitor Cell Product Sales by Application (2015-2020)5.1.2 Global Progenitor Cell Product Revenue by Application (2015-2020)5.1.3 Progenitor Cell Product Price by Application (2015-2020)5.2 Progenitor Cell Product Market Size Forecast by Application (2021-2026)5.2.1 Global Progenitor Cell Product Sales Forecast by Application (2021-2026)5.2.2 Global Progenitor Cell Product Revenue Forecast by Application (2021-2026)5.2.3 Global Progenitor Cell Product Price Forecast by Application (2021-2026) 6 North America6.1 North America Progenitor Cell Product by Country6.1.1 North America Progenitor Cell Product Sales by Country6.1.2 North America Progenitor Cell Product Revenue by Country6.1.3 U.S.6.1.4 Canada6.2 North America Progenitor Cell Product Market Facts & Figures by Type6.3 North America Progenitor Cell Product Market Facts & Figures by Application 7 Europe7.1 Europe Progenitor Cell Product by Country7.1.1 Europe Progenitor Cell Product Sales by Country7.1.2 Europe Progenitor Cell Product Revenue by Country7.1.3 Germany7.1.4 France7.1.5 U.K.7.1.6 Italy7.1.7 Russia7.2 Europe Progenitor Cell Product Market Facts & Figures by Type7.3 Europe Progenitor Cell Product Market Facts & Figures by Application 8 Asia Pacific8.1 Asia Pacific Progenitor Cell Product by Region8.1.1 Asia Pacific Progenitor Cell Product Sales by Region8.1.2 Asia Pacific Progenitor Cell Product Revenue by Region8.1.3 China8.1.4 Japan8.1.5 South Korea8.1.6 India8.1.7 Australia8.1.8 Taiwan8.1.9 Indonesia8.1.10 Thailand8.1.11 Malaysia8.1.12 Philippines8.1.13 Vietnam8.2 Asia Pacific Progenitor Cell Product Market Facts & Figures by Type8.3 Asia Pacific Progenitor Cell Product Market Facts & Figures by Application 9 Latin America9.1 Latin America Progenitor Cell Product by Country9.1.1 Latin America Progenitor Cell Product Sales by Country9.1.2 Latin America Progenitor Cell Product Revenue by Country9.1.3 Mexico9.1.4 Brazil9.1.5 Argentina9.2 Central & South America Progenitor Cell Product Market Facts & Figures by Type9.3 Central & South America Progenitor Cell Product Market Facts & Figures by Application 10 Middle East and Africa10.1 Middle East and Africa Progenitor Cell Product by Country10.1.1 Middle East and Africa Progenitor Cell Product Sales by Country10.1.2 Middle East and Africa Progenitor Cell Product Revenue by Country10.1.3 Turkey10.1.4 Saudi Arabia10.1.5 U.A.E10.2 Middle East and Africa Progenitor Cell Product Market Facts & Figures by Type10.3 Middle East and Africa Progenitor Cell Product Market Facts & Figures by Application 11 Company Profiles11.1 NeuroNova AB11.1.1 NeuroNova AB Corporation Information11.1.2 NeuroNova AB Description, Business Overview and Total Revenue11.1.3 NeuroNova AB Sales, Revenue and Gross Margin (2015-2020)11.1.4 NeuroNova AB Progenitor Cell Product Products Offered11.1.5 NeuroNova AB Recent Development11.2 StemCells11.2.1 StemCells Corporation Information11.2.2 StemCells Description, Business Overview and Total Revenue11.2.3 StemCells Sales, Revenue and Gross Margin (2015-2020)11.2.4 StemCells Progenitor Cell Product Products Offered11.2.5 StemCells Recent Development11.3 ReNeuron Limited11.3.1 ReNeuron Limited Corporation Information11.3.2 ReNeuron Limited Description, Business Overview and Total Revenue11.3.3 ReNeuron Limited Sales, Revenue and Gross Margin (2015-2020)11.3.4 ReNeuron Limited Progenitor Cell Product Products Offered11.3.5 ReNeuron Limited Recent Development11.4 Asterias Biotherapeutics11.4.1 Asterias Biotherapeutics Corporation Information11.4.2 Asterias Biotherapeutics Description, Business Overview and Total Revenue11.4.3 Asterias Biotherapeutics Sales, Revenue and Gross Margin (2015-2020)11.4.4 Asterias Biotherapeutics Progenitor Cell Product Products Offered11.4.5 Asterias Biotherapeutics Recent Development11.5 Thermo Fisher Scientific11.5.1 Thermo Fisher Scientific Corporation Information11.5.2 Thermo Fisher Scientific Description, Business Overview and Total Revenue11.5.3 Thermo Fisher Scientific Sales, Revenue and Gross Margin (2015-2020)11.5.4 Thermo Fisher Scientific Progenitor Cell Product Products Offered11.5.5 Thermo Fisher Scientific Recent Development11.6 STEMCELL Technologies11.6.1 STEMCELL Technologies Corporation Information11.6.2 STEMCELL Technologies Description, Business Overview and Total Revenue11.6.3 STEMCELL Technologies Sales, Revenue and Gross Margin (2015-2020)11.6.4 STEMCELL Technologies Progenitor Cell Product Products Offered11.6.5 STEMCELL Technologies Recent Development11.7 Axol Bio11.7.1 Axol Bio Corporation Information11.7.2 Axol Bio Description, Business Overview and Total Revenue11.7.3 Axol Bio Sales, Revenue and Gross Margin (2015-2020)11.7.4 Axol Bio Progenitor Cell Product Products Offered11.7.5 Axol Bio Recent Development11.8 R&D Systems11.8.1 R&D Systems Corporation Information11.8.2 R&D Systems Description, Business Overview and Total Revenue11.8.3 R&D Systems Sales, Revenue and Gross Margin (2015-2020)11.8.4 R&D Systems Progenitor Cell Product Products Offered11.8.5 R&D Systems Recent Development11.9 Lonza11.9.1 Lonza Corporation Information11.9.2 Lonza Description, Business Overview and Total Revenue11.9.3 Lonza Sales, Revenue and Gross Margin (2015-2020)11.9.4 Lonza Progenitor Cell Product Products Offered11.9.5 Lonza Recent Development11.10 ATCC11.10.1 ATCC Corporation Information11.10.2 ATCC Description, Business Overview and Total Revenue11.10.3 ATCC Sales, Revenue and Gross Margin (2015-2020)11.10.4 ATCC Progenitor Cell Product Products Offered11.10.5 ATCC Recent Development11.1 NeuroNova AB11.1.1 NeuroNova AB Corporation Information11.1.2 NeuroNova AB Description, Business Overview and Total Revenue11.1.3 NeuroNova AB Sales, Revenue and Gross Margin (2015-2020)11.1.4 NeuroNova AB Progenitor Cell Product Products Offered11.1.5 NeuroNova AB Recent Development11.12 CDI11.12.1 CDI Corporation Information11.12.2 CDI Description, Business Overview and Total Revenue11.12.3 CDI Sales, Revenue and Gross Margin (2015-2020)11.12.4 CDI Products Offered11.12.5 CDI Recent Development 12 Future Forecast by Regions (Countries) (2021-2026)12.1 Progenitor Cell Product Market Estimates and Projections by Region12.1.1 Global Progenitor Cell Product Sales Forecast by Regions 2021-202612.1.2 Global Progenitor Cell Product Revenue Forecast by Regions 2021-202612.2 North America Progenitor Cell Product Market Size Forecast (2021-2026)12.2.1 North America: Progenitor Cell Product Sales Forecast (2021-2026)12.2.2 North America: Progenitor Cell Product Revenue Forecast (2021-2026)12.2.3 North America: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.3 Europe Progenitor Cell Product Market Size Forecast (2021-2026)12.3.1 Europe: Progenitor Cell Product Sales Forecast (2021-2026)12.3.2 Europe: Progenitor Cell Product Revenue Forecast (2021-2026)12.3.3 Europe: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.4 Asia Pacific Progenitor Cell Product Market Size Forecast (2021-2026)12.4.1 Asia Pacific: Progenitor Cell Product Sales Forecast (2021-2026)12.4.2 Asia Pacific: Progenitor Cell Product Revenue Forecast (2021-2026)12.4.3 Asia Pacific: Progenitor Cell Product Market Size Forecast by Region (2021-2026)12.5 Latin America Progenitor Cell Product Market Size Forecast (2021-2026)12.5.1 Latin America: Progenitor Cell Product Sales Forecast (2021-2026)12.5.2 Latin America: Progenitor Cell Product Revenue Forecast (2021-2026)12.5.3 Latin America: Progenitor Cell Product Market Size Forecast by Country (2021-2026)12.6 Middle East and Africa Progenitor Cell Product Market Size Forecast (2021-2026)12.6.1 Middle East and Africa: Progenitor Cell Product Sales Forecast (2021-2026)12.6.2 Middle East and Africa: Progenitor Cell Product Revenue Forecast (2021-2026)12.6.3 Middle East and Africa: Progenitor Cell Product Market Size Forecast by Country (2021-2026) 13 Market Opportunities, Challenges, Risks and Influences Factors Analysis13.1 Market Opportunities and Drivers13.2 Market Challenges13.3 Market Risks/Restraints13.4 Porters Five Forces Analysis13.5 Primary Interviews with Key Progenitor Cell Product Players (Opinion Leaders) 14 Value Chain and Sales Channels Analysis14.1 Value Chain Analysis14.2 Progenitor Cell Product Customers14.3 Sales Channels Analysis14.3.1 Sales Channels14.3.2 Distributors 15 Research Findings and Conclusion 16 Appendix16.1 Research Methodology16.1.1 Methodology/Research Approach16.1.2 Data Source16.2 Author Details

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Trending: Progenitor Cell Product Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 - Weekly Wall

Cardiac Stem Cells Comments Off on Trending: Progenitor Cell Product Market Detailed Analysis of Current Industry Figures With Forecasts Growth by 2026 – Weekly Wall | June 14th, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) announced that new data from its ongoing Phase 1/2 HGB-206 study of investigational LentiGlobin gene therapy for adult and adolescent patients with sickle cell disease (SCD) show a near-complete reduction of serious vaso-occlusive crises (VOCs) and acute chest syndrome (ACS). These data are being presented at the Virtual Edition of the 25th European Hematology Association (EHA25) Annual Congress.

Vaso-occlusive crises (VOCs) are the painful, life-threatening episodes that are the primary clinical manifestation of sickle cell disease. The nearly complete elimination of VOCs that we saw in this study is impressive and demonstrates the potential of LentiGlobin for SCD as a treatment for this serious disease, said David Davidson, M.D., chief medical officer, bluebird bio. These results illustrate the type of outcomes we believe are needed to provide truly meaningful improvements for people living with sickle cell disease. In addition, the improvement of laboratory measures of hemolysis and red cell physiology, with nearly pan-cellular distribution of the anti-sickling HbAT87Q, suggest LentiGlobin for SCD may substantially modify the causative pathophysiology of SCD. We are pleased to have reached a general agreement with the FDA on the clinical data required to support a submission for LentiGlobin for SCD and we plan to seek an accelerated approval. We look forward to working with the entire SCD community to bring forward a disease modifying option for patients.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and unpredictable, painful VOCs. For adults and children living with SCD, this means painful crises and other life altering or life-threatening acute complicationssuch as ACS, stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.

As a physician treating sickle cell for over 10 years, the excruciating pain crises that my patients suffer from is one of the most challenging and frustrating aspects of this disease, said presenting study author Julie Kanter, M.D., University of Alabama at Birmingham. The promising results of this study, which show patients have an almost complete elimination of VOCs and ACS, suggest LentiGlobin for SCD has real potential to provide a significant impact for people living with sickle cell disease.

LentiGlobin for SCD was designed to add functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once patients have the A-T87Q-globin gene, their red blood cells can produce anti-sickling hemoglobin, HbAT87Q, that decreases the proportion of HbS, with the goal of reducing sickled red blood cells, hemolysis and other complications.

As of March 3, 2020, a total of 37 patients have been treated with LentiGlobin for SCD to-date in the HGB-205 (n=3) and HGB-206 (n=34) clinical studies. The HGB-206 total includes: Group A (n=7), B (n=2) and C (n=25).

HGB-206: Group C Updated Efficacy Results

In Group C of HGB-206, 25 patients were treated with LentiGlobin for SCD and have up to 24.8 months of follow-up (median of 12.1; min.-max.: 2.824.8 months). Results from Group C are as of March 3, 2020 and include efficacy data for 16 patients who had at least a Month 6 visit, and safety data for 18 patients, which includes two patients who were at least six months post-treatment but results from a Month 6 visit are not available.

In 16 patients with six or more months of follow-up, median levels of gene therapy-derived anti-sickling hemoglobin, HbAT87Q, were maintained with HbAT87Q contributing at least 40% of total hemoglobin. At last visit reported, total hemoglobin ranged from 9.6 16.2 g/dL and HbAT87Q levels ranged from 2.7 9.4 g/dL. At Month 6 the production of HbAT87Q was associated with a reduction in the proportion of HbS in total hemoglobin. Patients had a median of 60% HbS. All patients in Group C were able to stop regular blood transfusions and remain off transfusions at three months post-treatment.

There was a 99.5% mean reduction in annualized rate of VOC and ACS among the 14 patients who had at least six months of follow-up and a history of VOCs or ACS, defined as four or more VOC or ACS events in the two years prior to treatment. These 14 patients had a median of eight events in the two years prior to treatment (min.-max.: 4 28 events).

There were no reports of serious VOCs or ACS at up to 24 months post-treatment in patients with at least six months of follow-up (n=18). As previously reported, one non-serious Grade 2 VOC was observed in a patient approximately 3.5 months post-treatment with LentiGlobin for SCD.

In sickle cell disease, red blood cells become sickled and fragile, rupturing more easily than healthy red blood cells. The breakdown of red blood cells is hemolysis and this process occurs normally in the body. However, in sickle cell disease hemolysis happens too quickly due to the fragility of the red blood cells, which results in hemolytic anemia.

Patients treated with LentiGlobin for SCD demonstrated improvement in key markers of hemolysis, which are indicators of the health of red blood cells. Lab results assessing these indicators were available for the majority of the 18 patients with 6 months of follow-up. The medians for reticulocyte counts (n=15), lactate dehydrogenase (LDH) levels (n=13) and total bilirubin (n=16) improved compared to screening and stabilized by Month 6. In patients with Month 24 data (n=5) these values approached the upper limit of normal by Month 24. These results suggest treatment with LentiGlobin for SCD is improving biological markers of sickle cell disease.

Assays were developed by bluebird bio to enable the detection of HbAT87Q and HbS protein in individual red blood cells as well as to assess if HbAT87Q was pancellular, present throughout all of a patients red blood cells. Samples from a subset of patients in Group C were assessed. In nine patients who had at least six months of follow-up, the average proportion of red blood cells positive for HbAT87Q was greater than 70%, and on average more than 85% of red blood cells contained HbAT87Q at 18 months post-treatment, suggesting near-complete pancellularity of HbAT87Q distribution.

HGB-206: Group C Safety Results

As of March 3, 2020, the safety data from all patients in HGB-206 are generally reflective of underlying SCD and the known side effects of hematopoietic stem cell collection and myeloablative conditioning. There were no serious adverse events related to LentiGlobin for SCD, and the non-serious, related adverse events (AEs) were mild-to-moderate in intensity and self-limited.

One patient with a history of frequent pre-treatment VOE, pulmonary and systemic hypertension, venous thrombosis, obesity, sleep apnea and asthma had complete resolution of VOEs following treatment, but suffered sudden death 20 months after treatment with LentiGlobin for SCD. The patients autopsy revealed cardiac enlargement and fibrosis, and concluded the cause of death was cardiovascular, with contributions from SCD and asthma. The treating physician and an independent monitoring committee agreed this death was unlikely related to LentiGlobin for SCD gene therapy.

The presentation is now available on demand on the EHA25 website:

About HGB-206

HGB-206 is an ongoing, Phase 1/2 open-label study designed to evaluate the efficacy and safety of LentiGlobin gene therapy for SCD that includes three treatment cohorts: Groups A (n=7), B (n=2) and C (n=25). A refined manufacturing process that was designed to increase vector copy number (VCN) and improve engraftment potential of gene-modified stem cells was used for Group C. Group C patients also received LentiGlobin for SCD made from HSCs collected from peripheral blood after mobilization with plerixafor, rather than via bone marrow harvest, which was used in Groups A and B of HGB-206.

LentiGlobin for Sickle Cell Disease Regulatory Status

bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.

bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.

About LentiGlobin for Sickle Cell Disease

LentiGlobin for sickle cell disease is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

LentiGlobin for SCD received orphan medicinal product designation from the European Commission for the treatment of SCD.

The U.S. FDA granted orphan drug designation, regenerative medicine advanced therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for SCD.

LentiGlobin for SCD is investigational and has not been approved in any geography.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel for -thalassemia or LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders, including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition; cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash., Durham, N.C., and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

LentiGlobin and bluebird bio are trademarks of bluebird bio, Inc.

bluebird bio Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys development and regulatory plans for the LentiGlobin for SCD product candidate, and the companys intentions regarding the timing for providing further updates on the development of the product candidate. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the COVID-19 pandemic and resulting impact on our operations and healthcare systems will affect the execution of our development plans or the conduct of our clinical studies; the risk that even if LentiGlobin for SCD addresses ACS and VOC events, that it may not address progressive organ damage experienced by patients with SCD; the risk that the efficacy and safety results observed in the patients treated in our prior and ongoing clinical trials of LentiGlobin for SCD may not persist or be durable; the risk that the efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in when treating additional patients in our ongoing or planned clinical trials; the risk that the HGB-206 and HGB-210 clinical studies as currently contemplated may be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidate, resulting in a delay to our anticipated timelines for regulatory submissions, including our application for marketing approval. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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New Data Show Near Elimination of Sickle Cell Disease-Related Vaso-Occlusive Crises and Acute Chest Syndrome in Phase 1/2 Clinical Study of bluebird...

Cardiac Stem Cells Comments Off on New Data Show Near Elimination of Sickle Cell Disease-Related Vaso-Occlusive Crises and Acute Chest Syndrome in Phase 1/2 Clinical Study of bluebird… | June 13th, 2020

Lately, there has been rising awareness among people regarding the therapeutic potential of stem cells for disease management. This is one of the key factors contributing to growth of the global stem cell therapy market.

Further, identification of new stem cell lines, research and development of genome based cell analysis techniques, and investment inflow for processing and banking of stem cell are some of the significant factors augmenting expansion rate of the global stem cell therapy market.

Meanwhile, limitations associated with traditional organ transplantation such as immunosuppression risk, infection risk, and low acceptance rate of organ by body are few features leading to adoption of stem cell therapy. Moreover, high dependency on organ donors for organ transplantation is paving opportunities for growth of the stem cell therapy.

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Moreover, expanding pipeline and development of drugs for new applications are driving growth of the global stem cells market. Growing research activities focused on augmenting the application array of stem cell will also widen the horizon of stem cell market. Researchers are consistently trying to develop novel methods for creating human stem cell in order to comply with the rising demand for stem cell production to be used for disease management.

Development of Advanced Treatment Method Augmenting Market Growth

Lately, various new studies, development of novel therapies, and research projects have come into light in the global stem cell therapy market. Some of these treatment have been by approved by regulatory bodies, while others are still in pipeline for approval of the treatment.

In March 2017, Belgian based biotech firm TiGenix has announced that its latest development- cardiac cell therapy AlloCSC-01 has reached in its phase I/II successfully. It has shown positive results. Meanwhile, the U.S. FDA has also approved the treatment method. If this therapy is well-accepted among the patients, then approximately 1.9 million AMI patients could be treated using the therapy.

Likewise, another significant development that has been witnessed is development novel stem cell based technology for treatment of multiple sclerosis (MS) and similar concerns associated with nervous system. The treatment is developed by Israel-based Kadimastem Ltd. Also, the Latest development has been granted a patent by reputed regulatory body.

Some of the prominent companies operating in the global stem cell therapy landscape are Anterogen Co. Ltd., RTI Surgical, Osiris Therapeutics Inc., Holostem Terapie Avanzate S.r.l., JCR Pharmaceuticals Co. Ltd., MEDIPOST Co. Ltd., Pharmicell Co. Ltd., and NuVasive Inc.

Some of these firms are following various growth strategies such as mergers and acquisitions, strategic alliances, and collaborations, and product development in order to strengthen their foothold in the global market for stem cell therapy.

Dermatology Segment Holds Prominence in Stem Cell Therapy Market

Stem cell therapy, primarily is a regenerative medicine. It encourages the reparative response of damaged, dysfunctional, or diseases tissue with the help of stem cells and associated derivatives. The treatment method is replacing the conventional transplant methods.

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Stem cell therapy method has wide array of application in the field of nervous system treatment, dermatology, bone marrow transplant, multiple sclerosis, osteoarthritis, hearing loss treatment, cerebral palsy, and heart failure. The method aids patients fight leukemia and similar blood related diseases.

Among all, dermatology segment is leading in the global stem cell therapy market. The segment is substantially contributing to growth of the market. Stem cell therapy reduces the after effects of general treatment for burns such as adhesion, infections, and scars among others.

Meanwhile, rising number of patient suffering from diabetes and increase in trauma surgery cases are anticipated to accelerate the adoption of stem cell therapy in the dermatology segment.

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Stem Cell Therapy Market Grows on Back of Growing Awareness Regarding Regenerative Treatment Methods - TMR Research Blog

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Grows on Back of Growing Awareness Regarding Regenerative Treatment Methods – TMR Research Blog | June 13th, 2020

The Canine Stem Cell Therapy Market research report enhanced worldwide Coronavirus COVID19 impact analysis on the market size (Value, Production and Consumption), splits the breakdown (Data Status 2014-2020 and 6 Year Forecast From 2020 to 2026), by region, manufacturers, type and End User/application. This Canine Stem Cell Therapy market report covers the worldwide top manufacturers like (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) which including information such as: Capacity, Production, Price, Sales, Revenue, Shipment, Gross, Gross Profit, Import, Export, Interview Record, Business Distribution etc., these data help the consumer know about the Canine Stem Cell Therapy market competitors better. It covers Regional Segment Analysis, Type, Application, Major Manufactures, Canine Stem Cell Therapy Industry Chain Analysis, Competitive Insights and Macroeconomic Analysis.

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Scope of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry.

On the basis on the end users/applications,this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate foreach application.

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.

Allogeneic Stem Cells Autologous Stem cells

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Geographically, the report includes the research on production, consumption, revenue, Canine Stem Cell Therapy market share and growth rate, and forecast (2020-2026) of the following regions:

Important Canine Stem Cell Therapy Market Data Available In This Report:

Strategic Recommendations, Forecast Growth Areasof the Canine Stem Cell Therapy Market.

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Canine Stem Cell Therapy Market ShareYear-Over-Year Growthof Key Players in Promising Regions.

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Coronavirus threat to global Good Growth Opportunities in Canine Stem Cell Therapy Market - Cole of Duty

Cardiac Stem Cells Comments Off on Coronavirus threat to global Good Growth Opportunities in Canine Stem Cell Therapy Market – Cole of Duty | June 13th, 2020

For millions of Americans, though, keeping normalcy at bay for such a long time is a luxury they cant afford. People need to hold onto their jobs. Or find new ones. The streets are filling up with Americans who are responding to one national crisisthat of police brutality and systemic racismin the midst of another. And the economy is in cardiac arrest.

Just last week, to address this, the governor of my state announced an accelerated reopening. In the last weeks, there were about 1,500 new coronavirus cases in our region, an increase of 37 percent. In all these headlines, I can see cracks in the walls Ive built around my mom and my partner. How do we bubble people stay safe as the world moves ahead? In some ways people who are immunocompromised have lived their lives in preparation for all of this, Mamjunder told me.

Not long ago, in response to WIRED's Covid-19 coverage, the publication got an email from a woman named Brandy Stephens whod been diagnosed with acute lymphoblastic leukemia in 2014, when she was 26. She and her husband had a 1-year-old daughter. Her treatment put her in the hospital for 165 days, 35 of them on a ventilator. During that time a mere houseplant could have killed me, she wrote. I had multi-organ failure, my bone marrow died, I had pulmonary embolisms, a partially collapsed lung. Then, a stem cell transplant built her a new immune system. In July 2019, at the five-year mark, Stephens was finally able to be reimmunized, against the scary things that babies are immunized for.

Most of the world does not know we exist, she wrote.

I called her to ask about how she did it. I needed to know how to shepherd my mom and partner through a reopened world. I couldn't eat takeout for a year post-transplant. I carry sanitizer, gloves, masks, Lysol with me. She added, My husband is my rock. It has become second nature to have real quirks, to, say, go to family gatherings but not get close to anyone. She knows how to do this. I feel for people who never have had to isolate before, she added, I went through that struggle. (Immunocompromised people have figured out how to protest too.)

We are lucky to live in an area that has kept the overall coronavirus numbers low, yet the steady tick of reminders about potential Covid-19 resurgences haunt me. For everyone in this pandemic, its hard right now to accurately see a future beyond quarantine. Will we return to normal this year? What does normal mean? Something different for all of us, of course.

Last Friday afternoon I was working at Moms house, and I took a break. We were sitting in her living room, on her lovely blue couches. The dog tucked his head under her arm. Mom asked me what I was looking forward to.

The question jolted me. In pre-corona times, I tried to keep things on the calendar to look forward to. But over the past two months I have shut that instinct down.

Now, my mind ricocheted. Restaurants. Could I look forward to eating at our favorite pizza joint? My partners brother: He just added a new floor at the top of the house, a big glorious room with sliding glass doors that open to a porch overlooking the Pacific. He wants to have parties in that big, cheerful space. Will we be there?

Here are the things I hope to put on my calendar someday soon: dinner at our friends house. Driving with Mom for a day at our favorite beach, without worrying about crowds. Those parties at my partners brothers house, in that big, cheerful space. And if need be, flights to a different city if the new treatments we need for my partners cancer arrive, via a trial, somewhere else.

I hope I can put all of those things on the calendar, for the time we have left together.

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Progenitor Cell Product Market Global and Outlook (2016 2026)

The report published onProgenitor Cell Productis an invaluable foundation of insightful data helpful for the decision-makers to form the business strategies related to R&D investment, sales and growth, key trends, technological advancement, emerging market and more.The COVID-19 outbreak is currently going the world over, this report covers the impact of the corona-virus on leading companies in the Progenitor Cell Product sector. This research report categorizes as the key players in the Progenitor Cell Product market and also gives a comprehensive study of Covid-19 impact analysis of the market by type, application and by regions like (Americas, APAC, and EMEA).

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The global Progenitor Cell Product market report includes key facts and figures data which helps its users to understand the current scenario of the global market along with anticipated growth. The Progenitor Cell Product market report contains quantitative data such as global sales and revenue (USD Million) market size of different categories and subcategories such as regions, CAGR, market shares, revenue insights of market players, and others. The report also gives qualitative insights into the global Progenitor Cell Product market, which gives the exact outlook of the global as well as country level Progenitor Cell Product market.

Major Companies Profiled in the Global Progenitor Cell Product Market are:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

The focus of the global Progenitor Cell Product market report is to define, categorized, identify the Progenitor Cell Product market in terms of its parameter and specifications/ segments for example by product, by types, by applications, and by end-users. This study also provides highlights on market trends, market dynamics (drivers, restraints, opportunities, challenges), which are impacting the growth of the Progenitor Cell Product market.

By Type, the Progenitor Cell Product market is segmented into:Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

By Application, the Progenitor Cell Product market is segmented into:Medical care, Hospital, Laboratory

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Progenitor Cell Product Market Regional Analysis

The Regions covered in this study are North America, Europe, Middle East & Africa, Latin America, and the Asia Pacific. It analyzes these regions on the basis of major countries in it. Countries analyzed in the scope of the report are the U.S., Canada, Germany, the UK, France, Spain, Italy, China, India, Japan, South Korea, Southeast Asian countries, Australia, Brazil, Mexico, GCC countries, Egypt, South Africa, and Turkey among others.

Main Highlights and Significant aspects of the Reports:

A comprehensive look at the Progenitor Cell Product Industry Changing business trends in the global Progenitor Cell Product market Historical and forecast size of the Progenitor Cell Product market in terms of Revenue (USD Million) Detailed market bifurcation analysis at a various level such as type, application, end-user, Regions/countries Current industry growth and market trends Player positioning analysis and Competitive Landscape analysis for the Progenitor Cell Product market Key Product presents by Major players and business strategies used Niche and Potential segments (ex. types, applications, and regions/countries) predicted to revealed promising growth Key challenges encountered by operating players in the market space Analysis of major risks linked with the market operations

Browse Full Research Report [emailprotected]https://www.syndicatemarketresearch.com/market-analysis/progenitor-cell-product-market.html

Overview:This segment offers an overview of the report to provide an idea regarding the contents and nature of the research report along with a wide synopsis of the global Progenitor Cell Product Market.

Analysis of Leading Players Strategies:Market top players can utilize this analysis to increase the upper hand over their rivals in the market.

Study on Major Market Trends:This segment of the report delivers a broad analysis of the most recent and future market trends.

Forecasts of the Market:The report gives production, consumption, sales, and other market forecasts. Report Buyers will approach exact and approved evaluations of the total market size in terms of value and volume.

Analysis of Regional Growth:This report covered all major regions and countries. The regional analysis will assist market players to formulate strategies specific to target regions, tap into unexplained regional markets, and compare the growth of all regional markets.

Analysis of the Segment:This report provides a reliable and accurate forecast of the market share of important market segments. This analysis can be used by market participants for strategic development so that they can make significant growth in the Progenitor Cell Product market.

The main questions given in the report include:

1.What will be the market size and growth rate in 2026 with COVID-19 Impact Analysis?2.What are the major market trends impacting the growth of the global market with COVID-19 impact analysis?3.Who are the major players operating in the worldwide market?4.What are the important factors driving the worldwide Progenitor Cell Product market?5.What are the challenges to market growth?6.What are the opportunities and threats faced by the vendors in the international market?7.What are the trending factors affecting the market shares of the Americas, APAC, and EMEA?8.What are the major effects of the five forces analysis of the global Progenitor Cell Product market?

Note In order to provide a more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.(*If you have any special requirements, please let us know and we will offer you the report as you want.)

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Global Progenitor Cell Product Market 2020 with Coronavirus (COVID-19) Effect Analysis | likewise Industry is Booming Globally with Key Players ...

Cardiac Stem Cells Comments Off on Global Progenitor Cell Product Market 2020 with Coronavirus (COVID-19) Effect Analysis | likewise Industry is Booming Globally with Key Players … | June 13th, 2020

Health care stakeholders need to invest in value-based care, innovative care delivery models, advanced digital technologies. XploreMR will help you to know declarative, procedural, contextual, and somatic information about the Canine Stem Cell Therapy Market. It also provides a critical assessment of the performance of emerging and mature markets in a new publication titled Global Market Study on Canine Stem Cell Therapy: Ongoing Clinical Trials and Focus on Advancements to Push Adoption in Veterinary Clinics.

A synopsis of the global canine stem cell therapy market with reference to the global healthcare pharmaceutical industry

Despite the economic and political uncertainty in the recent past, the global healthcare industry has been receiving positive nudges from reformative and technological disruptions in medical devices, pharmaceuticals and biotech, in-vitro diagnostics, and medical imaging. Key markets across the world are facing a massive rise in demand for critical care services that are pushing global healthcare spending levels to unimaginable limits.

Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) and many more Information:https://www.xploremr.com/connectus/sample/2360

A rapidly multiplying geriatric population; increasing prevalence of chronic ailments such as cancer and cardiac disease; growing awareness among patients; and heavy investments in clinical innovation are just some of the factors that are impacting the performance of the global healthcare industry. Proactive measures such as healthcare cost containment, primary care delivery, innovation in medical procedures (3-D printing, blockchain, and robotic surgery to name a few), safe and effective drug delivery, and well-defined healthcare regulatory compliance models are targeted at placing the sector on a high growth trajectory across key regional markets.

Parent Indicators Healthcare

Research Methodology

XploreMR utilizes a triangulation methodology that is primarily based on experimental techniques such as patient-level data, to obtain precise market estimations and insights on Molecule and Drug Classes, API Formulations and preferred modes of administration. Bottom-up approach is always used to obtain insightful data for the specific country/regions. The country specific data is again analysed to derive data at a global level. This methodology ensures high quality and accuracy of information.

Secondary research is used at the initial phase to identify the age specific disease epidemiology, diagnosis rate and treatment pattern, as per disease indications. Each piece of information is eventually analysed during the entire research project which builds a strong base for the primary research information.

Primary research participants include demand-side users such as key opinion leaders, physicians, surgeons, nursing managers, clinical specialists who provide valuable insights on trends and clinical application of the drugs, key treatment patterns, adoption rate, and compliance rate.

Quantitative and qualitative assessment of basic factors driving demand, economic factors/cycles and growth rates and strategies utilized by key players in the market is analysed in detail while forecasting, in order to project Year-on-Year growth rates. These Y-o-Y growth projections are checked and aligned as per industry/product lifecycle and further utilized to develop market numbers at a holistic level.

On the other hand, we also analyse various companies annual reports, investor presentations, SEC filings, 10k reports and press release operating in this market segment to fetch substantial information about the market size, trends, opportunity, drivers, restraints and to analyse key players and their market shares. Key companies are segmented at Tier level based on their revenues, product portfolio and presence.

Please note that these are the partial steps that are being followed while developing the market size. Besides this, forecasting will be done based on our internal proprietary model which also uses different macro-economic factors such as per capita healthcare expenditure, disposable income, industry based demand driving factors impacting the market and its forecast trends apart from disease related factors.

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Standard Report Structure

Target Audience

Market Taxonomy

The global canine stem cell therapy market has been segmented into:

Product Type:

Application:

End User:

Region:

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Canine Stem Cell Therapy Market to Expand with Significant CAGR - WorldsTrend

Cardiac Stem Cells Comments Off on Canine Stem Cell Therapy Market to Expand with Significant CAGR – WorldsTrend | June 12th, 2020

Legendary German racing driver expects to implement the next batch of stem cells into heart tissue

Sevenfold champion of Formula 1 Michael Schumacher will have to go through another operation, according to GrandPX with reference to the Italian source Contro Copertina. As noted cardiac surgeon, Dr. Phillip Menashe, who was already engaged in treatment of the legendary German racer earlier, Schumacher will conduct the experimental operation on the introduction of stem cells into heart tissue.

Last year it was reported that Michael has already passed a similar procedure. The goal is to restore the nervous system Michael, said Menashe.

Neurosurgeon Dr. Nikola Acciari told that a famous former pilot Ferrari also suffers from muscle atrophy and osteoporosis. Over the last 20 years science has made enormous progress in the field of stem cell treatment. But it doesnt change the fact that we still know little about the human brain. We cant tell what results it will bring, said the doctor.

Michael Schumacher. Photo skysports.com

Recall Michael Schumacher suffered a severe head injury in December 2013 in the result of a fall at a ski resort in France. Since then Schumacher, who in January turned 51, never appeared in public.

About the state of his health there is no reliable information because the family prefers to keep it a secret. However, last fall it became known that Michael Schumacher is secretly transported to a clinic in Paris. In this case an unnamed member of the medical personnel told reporters: He is conscious.

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Doctors revealed details of the new rescue of Michael Schumacher - The Times Hub

Cardiac Stem Cells Comments Off on Doctors revealed details of the new rescue of Michael Schumacher – The Times Hub | June 10th, 2020