Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations – BioSpace
By daniellenierenberg
Sept. 14, 2020 10:45 UTC
BOTHELL, Wash. & KENILWORTH, N.J.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced two new strategic oncology collaborations.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200914005237/en/
The companies will globally develop and commercialize Seattle Genetics ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors. The collaboration will pursue a broad joint development program evaluating ladiratuzumab vedotin as monotherapy and in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab) in triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. Under the terms of the agreement, Seattle Genetics will receive a $600 million upfront payment and Merck will make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics is eligible for progress-dependent milestone payments of up to $2.6 billion.
Separately, Seattle Genetics has granted Merck an exclusive license to commercialize TUKYSA (tucatinib), a small molecule tyrosine kinase inhibitor, for the treatment of HER2-positive cancers, in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics will receive $125 million from Merck as an upfront payment and is eligible for progress-dependent milestones of up to $65 million.
Collaborating with Merck on ladiratuzumab vedotin will allow us to accelerate and broaden its development program in breast cancer and other solid tumors, including in combination with Mercks KEYTRUDA, while also positioning us to leverage our U.S. and European commercial operations, said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The strategic collaboration for TUKYSA will help us reach more patients globally and benefit from the established commercial strength of one of the worlds premier pharmaceutical companies.
These two strategic collaborations will enable us to further diversify Mercks broad oncology portfolio and pipeline, and to continue our efforts to extend and improve the lives of as many patients with cancer as possible, said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. We look forward to working with the team at Seattle Genetics to advance the clinical program for ladiratuzumab vedotin, which has shown compelling signals of efficacy in early studies, and to bring TUKYSA to even more patients with cancer around the world.
Ladiratuzumab Vedotin Collaboration Details
Under the terms of the agreement, Seattle Genetics and Merck will collaborate and equally share costs on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs. The companies have agreed to jointly develop and share future costs and profits for ladiratuzumab vedotin on a 50:50 basis worldwide. Merck will pay Seattle Genetics $600 million upfront and make a $1.0 billion equity investment in 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics will be eligible to receive up to $2.6 billion in milestone payments, including $850 million in development milestones and $1.75 billion in sales milestones.
The companies will jointly develop and commercialize ladiratuzumab vedotin and equally share profits worldwide. The companies will co-commercialize in the U.S. and Europe. Seattle Genetics will be responsible for marketing applications for approval in the U.S. and Canada, and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in Europe and in countries outside the U.S. and Canada, and will record sales in countries outside the U.S., Europe and Canada. Including the upfront payment, equity investment proceeds and potential milestone payments, Seattle Genetics is eligible to receive up to $4.2 billion.
The closing of the equity investment is contingent on completion of review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).
TUKYSA Collaboration Details
Under the terms of the agreement, Merck has been granted exclusive rights to commercialize TUKYSA in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe. Seattle Genetics retains commercial rights and will record sales in the U.S., Canada and Europe. Merck will be responsible for marketing applications for approval in its territory, supported by the positive results from the HER2CLIMB clinical trial.
Merck will also co-fund a portion of the TUKYSA global development plan, which encompasses several ongoing and planned trials across HER2-positive cancers, including breast, colorectal, gastric and other cancers set forth in a global product development plan. Seattle Genetics will continue to lead ongoing TUKYSA global development planning and operational execution. Merck will solely fund and conduct country-specific clinical trials necessary to support anticipated regulatory applications in its territory.
Seattle Genetics will receive from Merck $125 million as an upfront payment and is eligible to receive progress-dependent milestones of up to $65 million. Seattle Genetics will also receive $85 million in prepaid research and development payments to be applied to Mercks global development funding obligations. In addition, Seattle Genetics would receive tiered royalties on sales of TUKYSA in Mercks territory.
The financial impact of these collaborations is not included in Seattle Genetics 2020 guidance.
Seattle Genetics Conference Call Details
Seattle Genetics management will host a conference call to discuss these collaborations today at 6:00 a.m. Pacific Time (PT); 9:00 a.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Seattle Genetics website at http://www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or +1 412-717-9224 (international). The conference ID is 10147850.
About Ladiratuzumab Vedotin
Ladiratuzumab vedotin is a novel investigational ADC targeted to LIV-1. Most metastatic breast cancers express LIV-1, which also has been detected in several other cancers, including lung, head and neck, esophageal and gastric. Ladiratuzumab vedotin utilizes Seattle Genetics proprietary ADC technology and consists of a LIV-1-targeted monoclonal antibody linked to a potent microtubule-disrupting agent, monomethyl auristatin E (MMAE) by a protease-cleavable linker. This novel ADC is designed to bind to LIV-1 on cancer cells and release the cell-killing agent into target cells upon internalization. Ladiratuzumab vedotin may also cause antitumor activity through other mechanisms, including activation of an immune response by induction of immunogenic cell death.
About TUKYSA (tucatinib)
TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth. TUKYSA in combination with trastuzumab and capecitabine was approved by the U.S. Food and Drug Administration (FDA) in April 2020 for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. In addition, TUKYSA received approval in Canada, Singapore, Australia and Switzerland under the Project Orbis initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners. A marketing application is under review in the European Union.
TUKYSA is being evaluated in several ongoing clinical trials and additional studies are planned. Current trials include the following:
For additional information, visit http://www.clinicaltrials.gov.
TUKYSA Important Safety Information
Warnings and Precautions
If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
Adverse Reactions
Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in 2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock.
Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in 1% of patients were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; those occurring in 2% of patients were hepatotoxicity (8%) and diarrhea (6%).
The most common adverse reactions in patients who received TUKYSA (20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash.
Lab Abnormalities
In HER2CLIMB, Grade 3 laboratory abnormalities reported in 5% of patients who received TUKYSA were: decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.
Drug Interactions
Use in Specific Populations
For more information, please see the full Prescribing Information for TUKYSA here.
About KEYTRUDA (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA (pembrolizumab) Indications
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Selected Important Safety Information for KEYTRUDA
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.
Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)
Immune-Mediated Hepatitis
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hepatotoxicity in Combination With Axitinib
KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.
Immune-Mediated Endocrinopathies
KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.
Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.
Immune-Mediated Nephritis and Renal Dysfunction
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.
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Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations - BioSpace
Exosome Therapeutic Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 – Good…
By daniellenierenberg
Global Exosome Therapeutic Market By Type (Natural Exosomes, Hybrid Exosomes), Source (Dendritic Cells, Mesenchymal Stem Cells, Blood, Milk, Body Fluids, Saliva, Urine Others), Therapy (Immunotherapy, Gene Therapy, Chemotherapy), Transporting Capacity (Bio Macromolecules, Small Molecules), Application (Oncology, Neurology, Metabolic Disorders, Cardiac Disorders, Blood Disorders, Inflammatory Disorders, Gynecology Disorders, Organ Transplantation, Others), Route of administration (Oral, Parenteral), End User (Hospitals, Diagnostic Centers, Research & Academic Institutes), Geography (North America, Europe, Asia-Pacific and Latin America)
Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.
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Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.
This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for an Analyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.
Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.
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Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process.
The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.
The major players covered in the report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.
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Covid-19 Impact On Induced Pluripotent Stem Cells (iPSCs) Market 2020 Is Thriving Globally With Horizon Discovery Ltd., Takara Bio Inc, Cell…
By daniellenierenberg
Induced pluripotent stem cells (iPSCs) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 2,442.97 million by 2027 growing at a CAGR of 7.5% in the above-mentioned forecast period. Increasing R&D investment activities is expected to create new opportunity for the market.
This induced pluripotent stem cells (iPSCs) market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market.
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Increasing demand for personalized regenerative cell therapies among medical researchers & healthcare is expected to enhance the market growth. Some of the other factors such as increasing cases of chronic diseases, growing awareness among patient, rising funding by government & private sectors and rising number of clinical trials is expected to drive the induced pluripotent stem cells (iPSCs) market in the forecast period of 2020 to 2027.
Global Induced Pluripotent Stem Cells (iPSCs) Market Scope and Market Size
Induced pluripotent stem cells (iPSCs) market is segmented of the basis of derived cell type, application and end- user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.
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The countries covered in the induced pluripotent stem cells (iPSCs) market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.
The country section of the induced pluripotent stem cells (iPSCs) market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.
The major players covered in the induced pluripotent stem cells (iPSCs) market report are Thermo Fisher Scientific Inc., FUJIFILM Corporation, Horizon Discovery Ltd., Takara Bio Inc, Cell Applications, Inc., Lonza Group AG, Evotec A.G., ViaCyte, Inc., CELGENE CORPORATION, Fate Therapeutics, Astellas Pharma Inc., among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.
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Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) – Kewaskum Statesman News Journal
By daniellenierenberg
Global Stem Cell Reconstructive Marketwas valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 24.5% during a forecast period.
Market Dynamics
The Research Report gives an in-depth account of the drivers and restraints in the stem cell reconstructive market. Stem cell reconstructive surgery includes the treatment of injured or dented part of body. Stem cells are undifferentiated biological cells, which divide to produce more stem cells. Growing reconstructive surgeries led by the rising number of limbs elimination and implants and accidents are boosting the growth in the stem cell reconstructive market. Additionally, rising number of aged population, number of patients suffering from chronic diseases, and unceasing development in the technology, these are factors which promoting the growth of the stem cell reconstructive market. Stem cell reconstructive is a procedure containing the use of a patients own adipose tissue to rise the fat volume in the area of reconstruction and therefore helping 3Dimentional reconstruction in patients who have experienced a trauma or in a post-surgical event such as a mastectomy or lumpectomy, brain surgery, or reconstructive surgery as a result of an accident or injury. Stem cell reconstructive surgeries are also used in plastic or cosmetic surgeries as well. Stem cell and regenerative therapies gives many opportunities for development in the practice of medicine and the possibility of an array of novel treatment options for patients experiencing a variety of symptoms and conditions. Stem cell therapy, also recognised as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.
The common guarantee of all the undifferentiated embryonic stem cells (ESCs), foetal, amniotic, UCB, and adult stem cell types is their indefinite self-renewal capacity and high multilineage differentiation potential that confer them a primitive and dynamic role throughout the developmental process and the lifespan in adult mammal.However, the high expenditure of stem cell reconstructive surgeries and strict regulatory approvals are restraining the market growth.
The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.
Global Stem Cell Reconstructive Market Segment analysis
Based on Cell Type, the embryonic stem cells segment is expected to grow at a CAGR of XX% during the forecast period. Embryonic stem cells (ESCs), derived from the blastocyst stage of early mammalian embryos, are distinguished by their capability to distinguish into any embryonic cell type and by their ability to self-renew. Owing to their plasticity and potentially limitless capacity for self-renewal, embryonic stem cell therapies have been suggested for regenerative medicine and tissue replacement after injury or disease. Additionally, their potential in regenerative medicine, embryonic stem cells provide a possible another source of tissue/organs which serves as a possible solution to the donor shortage dilemma. Researchers have differentiated ESCs into dopamine-producing cells with the hope that these neurons could be used in the treatment of Parkinsons disease. Upsurge occurrence of cardiac and malignant diseases is promoting the segment growth. Rapid developments in this vertical contain protocols for directed differentiation, defined culture systems, demonstration of applications in drug screening, establishment of several disease models, and evaluation of therapeutic potential in treating incurable diseases.
Global Stem Cell Reconstructive Market Regional analysis
The North American region has dominated the market with US$ XX Mn. America accounts for the largest and fastest-growing market of stem cell reconstructive because of the huge patient population and well-built healthcare sector. Americas stem cell reconstructive market is segmented into two major regions such as North America and South America. More than 80% of the market is shared by North America due to the presence of the US and Canada.
Europe accounts for the second-largest market which is followed by the Asia Pacific. Germany and UK account for the major share in the European market due to government support for research and development, well-developed technology and high healthcare expenditure have fuelled the growth of the market. This growing occurrence of cancer and diabetes in America is the main boosting factor for the growth of this market.
The objective of the report is to present a comprehensive analysis of the Global Stem Cell Reconstructive Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.
The report also helps in understanding Global Stem Cell Reconstructive Market dynamics, structure by analysing the market segments and projects the Global Stem Cell Reconstructive Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Stem Cell Reconstructive Market make the report investors guide.Scope of the Global Stem Cell Reconstructive Market
Global Stem Cell Reconstructive Market, By Sources
Allogeneic Autologouso Bone Marrowo Adipose Tissueo Blood Syngeneic OtherGlobal Stem Cell Reconstructive Market, By Cell Type
Embryonic Stem Cell Adult Stem CellGlobal Stem Cell Reconstructive Market, By Application
Cancer Diabetes Traumatic Skin Defect Severe Burn OtherGlobal Stem Cell Reconstructive Market, By End-User
Hospitals Research Institute OthersGlobal Stem Cell Reconstructive Market, By Regions
North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Stem Cell Reconstructive Market
Osiris Therapeutics NuVasives Cytori Therapeutics Takeda (TiGenix) Cynata Celyad Medi-post Anterogen Molmed Baxter Eleveflow Mesoblast Ltd. Micronit Microfluidics TAKARA BIO INC. Tigenix Capricor Therapeutics Astellas Pharma US, Inc. Pfizer Inc. STEMCELL Technologies Inc.
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Could COVID-19 have long-term effect on athletes’ health? – The Japan Times
By daniellenierenberg
While the sports world has attempted to prevent infections of COVID-19 and reduce its spread, some have raised concerns over the potential long-term consequences for athletes who have already been infected.
The virus has hit a number of star athletes. In Japan alone, Shintaro Fujinami of the Hanshin Tigers, Hayato Sakamoto of the Yomiuri Giants and Gotoku Sakai of the J. Leagues Vissel Kobe are among those who have tested positive.
Australian Mitch Langerak, a goalkeeper for Nagoya Grampus, became one of the J. Leagues first positive cases in early June. Fortunately he was asymptomatic and subsequently returned to the pitch when the leagues top flight resumed its season on July 4.
For me, it was a bit of a shock it was a major shock, Langerak told the Japan Times last month. (But) I didnt feel anything. I didnt feel any different. But I guess Im part of the exceptions, not the rule. I was very lucky.
As soon as I got out I tested negative twice, so I was OK to leave the hospital I was straight into training and within two days I was feeling strong and feeling back into it.
But in actuality, Langeraks experience is common among athletes in Japan who have tested positive for COVID-19, leaving some local medical officials optimistic about a lower risk of long-term effects. Yet the potential threat of reduced respiratory or pulmonary function looms large for those whose careers rely on being able to physically compete at the highest level.
Kentaro Iwata, professor of infectious disease at Kobe University, believes that athletes do not have to worry about whether the virus could severely affect their athletic performances after recovery.
Its evident if you look at the data: Athletes have been infected around the world, but the virus has barely caused any impact (on their post-recovery performances), Iwata said. In most cases, regardless of the sport, symptoms are mild and athletes recover naturally and return to their competitions. From the medical standpoint, there isnt much to be afraid of as far as athlete infections are concerned.
Iwata even described the virus as nearly harmless for healthy, young people, which can be used to describe most professional-level athletes, too.
Because the disease presents symptoms when the virus reaches a persons respiratory tract, it poses a possible risk to an athletes performance if their lungs are damaged as a result.
Iwata did not exclude the possibility, but described it as unlikely and said most people would face few or no symptoms during their recovery.
Vissel Kobes Gotoku Sakai has been infected with it, said Iwata, who is a fan of the Kansai-based soccer team. But after he received medical treatment and recovered, hes been running around at his highest level possible, playing twice a week or so.
There arent almost any problems with cardiopulmonary functions thats how its viewed generally. Im not going to deny that (a problem) could happen, though.
Kentaro Iwata, professor of infectious disease at Kobe University, believes athletes shouldnt fear long-term effects after recovering from the virus. | KAZ NAGATSUKA
Haruo Nakayama, a neurosurgeon and an infectious disease specialist for Toho University, did not rule out the possibility that the virus could affect respiratory systems long-term, even though currently available evidence is not yet conclusive.
The effect of the virus on respiratory systems after patients no longer need to be hospitalized has not been scientifically examined, Nakayama said. But when we observe the pictures of those infected and the symptoms that they claim after they are discharged, some of them have claimed to be physically worn out for a while, or it gets harder for them to exert themselves more than usual.
Thats not just older people, but there are some in their 20s and 30s claiming the same things.
Nakayama explained that the coronavirus could cause fibrosis in the lungs, causing the organs to lose flexibility.
If the lungs lose their flexibility, it could affect the cardiopulmonary functions of athletes and I would say the chance of that happening is not zero, he said.
Underlying medical conditions such as Type-1 diabetes, heart failure and respiratory disease can exacerbate the symptoms of the virus. Referring to Hanshin pitcher Minoru Iwata and Vissels Sergi Samper, who both are diabetic, Kentaro Iwata stated that high-risk patients, including those undergoing dialysis or using immunosuppressants or cariostatic drugs could be at risk for more severe symptoms.
To that end, Iwata criticized the participation of swimmer Rikako Ikee, who is recovering from leukemia, in a July event marking one year before the postponed Olympics at the National Stadium.
She had leukemia and (hematopoietic stem cell transplantation) and must have had so many immunosuppressive drugs, which made her weaker to infectious diseases, not just to the coronavirus, Iwata said. Im very angry with the people that brought her out to say something like Lets hope to have a (successful) Olympics next year. I think thats cruel.
While Iwata draws a positive image of athletes post-infection performances, team medical staff working directly with athletes as well as overseas medical officials who have dealt with higher numbers of severe cases have stronger concerns over potential long-term implications.
Nobuhisa Yoshida, a sports science and performance director for the B. Leagues Sunrockers Shibuya, said that athletes with more severe symptoms, if hospitalized for two to three weeks and quarantined further upon release, could require more time to return to their peak condition after experiencing decreases in activity levels and cardiopulmonary functions.
And if (their time away from training) gets longer, it could cause a decline in the volume of muscle and muscle strength as well as slower reflexes, said Yoshida, who previously worked as an athletic performance assistant for the NBAs San Antonio Spurs.
The level of effects from the coronavirus could vary depending on athletes situations as well physical conditions can differ greatly depending on whether they are in or out of season.
If an athlete gets infected during the season, their fatigue level is higher, Yoshida said. So you (as a medical staffer) try to develop the athletes physical condition steadily. If you can check the degree of the athletes physical decline based on data, you can check their readiness and make sure to bring it to where he can finally play, then give him a green light.
Grampus goalkeeper Mitch Langerak (right) made a quick return to training after recovering from COVID-19 in June. | KYODO
Overseas, an increase in residual damage to coronavirus patients hearts and lungs have spurred studies on the viruss potential long-term consequences.
John Swartzberg, a clinical professor emeritus of infectious diseases and vaccinology at the University of California, Berkeley, told the schools news portal in July that the virus seems to accelerate a great deal of scarring in the lungs.
Swartzberg also said that COVID-19 can directly attack heart muscle cells, and that the cytokine storm an excessive release of molecules that trigger an inflammatory response by the body caused by the coronavirus can hurt the heart as well as the lungs. He stated that there is evidence both for and against long-term damage.
We dont know what the long-term effects of that may be, Swartzberg said. But it could be that we will have a population of people who survive COVID-19 only to go on and have chronic cardiac problems.
Swartzberg referred to the central nervous system and the kidneys as other organs that could potentially be damaged by the virus.
Myocarditis inflammation of the heart muscle has been linked to the coronavirus in reports in the United States and Europe.
Some athletes in the U.S. and Europe have reported persistent and residual symptoms, such as coughs, tachycardia and fatigue, many weeks to months after initial coronavirus infections.
These potential post-COVID-19 effects do not seem to have been discussed widely in Japan, where the focus has been on the number of infections and the death toll. In the U.S. and Europe, officials have debated the necessities of pathways for athletes to return to intensive practices and competitions, including heart and lung screenings.
Nakayama admitted that the lack of such discussion within the Japanese sports community was in part due to a lack of sufficient evidence.
But Nakayama who serves as the executive adviser of the B. Leagues anti-coronavirus team said that the group has internally discussed the potential damage athletes face, although it has not been able to specify them in the leagues guidelines.
He said that if two-thirds of an infected athletes lungs are damaged when they are hospitalized, it can easily be inferred that their performance post-recovery will be infected.
And whether the athletes performance would get back to normal after working on rehab and all that, half a year or nine months later? Thats something we are going to find out later, Nakayama said. We dont know yet.
Staff writer Dan Orlowitz contributed to this story.
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Could COVID-19 have long-term effect on athletes' health? - The Japan Times
Post-COVID heart damage alarms researchers: ‘There was a black hole’ in infected cells – Yahoo Sports
By daniellenierenberg
Shelby Hedgecock contracted the coronavirus in April and thought she had fought through the worst of it the intense headaches, severe gastrointestinal distress and debilitating fatigue but early last month she started experiencing chest pain and a pounding heartbeat. Her doctor put her on a cardiac monitor and ordered blood tests, which indicated that the previously healthy 29-year-old had sustained heart damage, likely from her bout with COVID-19.
I never thought I would have to worry about a heart attack at 29 years old, Hedgecock told Yahoo News in an interview. I didnt have any complications before COVID-19 no preexisting conditions, no heart issues. I can deal with my taste and smell being dull, I can fight through the debilitating fatigue, but your heart has to last you a really long time.
Hedgecocks primary-care physician has referred her to a cardiologist she will see this week; the heart monitor revealed that Hedgecocks pulse rate is wildly irregular, ranging from 49 to 189 beats per minute, and she has elevated inflammatory markers and platelet counts. She was told to go to the emergency room if her chest pain intensifies before she can see the specialist. A former personal trainer who is now out of breath just from walking around the room, Hedgecock is worried about what the future holds.
She is far from alone in her struggle. Dr. Ossama Samuel is a cardiologist at New Yorks Mount Sinai Hospital, where he routinely sees coronavirus survivors who are contending with cardiac complications. Samuel said his team has treated three young and otherwise healthy coronavirus patients who have developed myocarditis an inflammation of the heart muscle weeks to months after recovering from the virus.
Shelby Hedgecock in a hospital bed. (Shelby Hedgecock)
Myocarditis can affect how the heart pumps blood and trigger rapid or abnormal heart rhythms. It is particularly dangerous for athletes, doctors say, because it can go undetected and can result in a heart attack during strenuous exercise. In recent weeks, some collegiate athletes have reported cardiac complications from the coronavirus, underscoring the seriousness of the condition.
Last month, former Florida State basketball center Michael Ojo died from a heart attack in Serbia; Ojo had recovered from the coronavirus before he collapsed on the basketball court. An Ohio State University cardiologist found that between 10 and 13 percent of university athletes who had recovered from COVID-19 had myocarditis.When the Big Ten athletic conference announced the cancellation of its season last month, Commissioner Kevin Warren cited the risk of heart failure in athletes. Researchers have estimated that up to 20 percent of people who get the coronavirus sustain heart damage.
Samuel said he feels an obligation to warn people, particularly since some of the patients he and Mount Sinai colleagues have seen with myocarditis had only mild cases of the coronavirus months ago.
We are now seeing people three months after COVID who have pericarditis [inflammation of the sac around the heart] or myocarditis, Samuel said. He said he believes a small fraction of coronavirus survivors are sustaining heart damage, but when a disease is so widespread it is concerning that a tiny fraction is still sizable.
Samuel said he worries particularly about athletes participating in team sports, since many live together and spend time in close quarters. Teammates may all get the coronavirus and recover together, Samuel said, but the one who really gets that crazy myocarditis could be at risk of dying through exercise or training.
Story continues
Its a concern about what do you do: Should we do sports in general, should we do it in schools, should we do it in college, should we just do it for professionals who understand the risk and they're getting paid? Samuel asked. I hope we dont scare the public, but we should make people aware.
Samuel is recommending that patients recovering from COVID-19 with myocarditis avoid workouts for three to six months.
Todd McDevitt, who runs a stem-cell lab at Gladstone Institutes, which is affiliated with the University of California at San Francisco, recently published images that show how the coronavirus can directly invade the heart muscle. McDevitt said he was so alarmed when he saw a sample of heart muscle cells in a petri dish get diced by the coronavirus that he had trouble sleeping for nights afterward.
Todd McDevitt. (Facebook)
McDevitt said his teams research was spurred by their desire to understand if the coronavirus is entering heart cells and how it is affecting them. He was surprised to see the heart muscle samples he was studying react to a very small amount of the coronavirus, usually within 24 to 48 hours. He said the virus decimated the heart cells in his petri dishes.
Cell nuclei the hubs of all the genetic information, all of the nuclear DNA in many of the cells were gone, McDevitt said. There was a black hole literally where we would normally see the nuclear DNA. Thats also pretty bizarre.
While McDevitts study has not yet been peer-reviewed it is still in pre-print he said he felt compelled to share the findings as soon as possible. He said his team also sampled tissues from three COVID-19 patient autopsies and found similar damage in the heart muscles of those patients, none of whom had been flagged for myocarditis or heart problems while they were alive.
This is probably not the whole story yet, but we think we have insights into the beginning of when the virus would get into some of these people and what it might be doing that is concerning enough that we should probably let people know, because clinicians need to be thinking about this, McDevitt said in an interview. We dont have any means of bringing heart muscle back. ... This virus is [causing] a very different type of injury, and one we haven't seen before.
McDevitt said the chopped-up heart muscles he and his colleagues saw are so concerning because when the microfibers in the muscle are damaged, the heart cant properly contract.
If heart muscle cells are damaged and they cant regenerate themselves, then what youre looking at is someone who could prematurely have heart failure or heart disease due to the virus, McDevitt said. This could be a warning sign for a potential wave of heart disease that we could see in the future, and its in the survivors thats the concern.
McDevitt said he believes the risk of heart disease is serious and one people should consider as they assess their own risk of getting the coronavirus.
I am more scared today of contracting the virus, by far, than I was four months ago, he said.
In lab experiments, infection of heart muscle cells with SARS-CoV-2 caused long fibers to break apart into small pieces, shown above. (Gladstone)
The medical journal the Lancet recently reported that an 11-year-old child had died of myocarditis and heart failure after a bout of COVID-induced multisystem inflammatory syndrome (MIS-C). An autopsy showed coronavirus embedded in the childs cardiac tissue.
A recent study from Germany found that 78 percent of patients who had recovered from the coronavirus and who had only mild to moderate symptoms while ill with the disease had indications of cardiac involvement on MRIs conducted more than two months after their initial infection.Lead investigator Eike Nagel said it is concerning to see such widespread cardiac impact; six in 10 of the patients Nagels team studied experienced ongoing myocardial inflammation.
We found an astonishingly high level of cardiac involvement approximately two months after COVID infection, Nagel said in an email. These changes are much milder than observed in patients with severe acute myocarditis.
The scale of the cardiac impact on relatively healthy, young patients surprised many doctors. Nagel said the findings are significant on a population basis, and that the impact of COVID-19 on the heart must be studied more.
Dr. Gregg Fonarow. (UCLA)
Dr. Gregg Fonarow, chief of UCLAs Division of Cardiology and director of the Ahmanson-UCLA Cardiomyopathy Center, said the picture is evolving, but the new studies showing cardiac impact in even young people with mild cases of COVID-19 have raised troubling new questions.
We really do need to take seriously individuals that have had the infection and are having continued symptoms, [and] not just dismiss those symptoms, Fonarow said. There could be, in those who had milder or even asymptomatic cases, the potential for cardiac risk.
Fonarow said it is important to understand whether a more proactive screening and treatment approach is needed to better address the needs of patients who have recovered from the coronavirus and who may still have weakened heart function. Fonarow said he found McDevitts research to be potentially significant because it proves from a mechanistic standpoint that there can be direct cardiac injury from the virus itself.
Even if it were going to impact, say, 2 percent of the people that had COVID-19, when you think of the millions that have been infected, that ends up in absolute terms being a very large number of individuals, Fonarow said in an interview. You dont want people to be unduly alarmed, but on the other hand you dont want individuals to be complacent about, Oh, the mortality rate is so low with COVID-19, I dont really care if Im infected because the chances that it will immediately or in the next few weeks kill me is small enough, I dont need to be concerned. There are other consequences.
_____
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Post-COVID heart damage alarms researchers: 'There was a black hole' in infected cells - Yahoo Sports
Covid-19 Impact on Global Progenitor Cell Product Market 2020 Industry Opportunities And Development Analysis 2026: NeuroNova AB,R&D Systems,Asterias…
By daniellenierenberg
The aim of this detailed market research report on Progenitor Cell Product market is to offer readers, with ample competitive edge in the context of market dynamics such as challenges, barriers, threats and opportunities that orchestrate high end growth amidst stringent competition in global Progenitor Cell Product market.
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Global Progenitor Cell Product Market: Understanding Scope:
The aforementioned Progenitor Cell Product market has been evaluated to register a thumping growth of xx million USD in 2020 and is anticipated to further attain a growth valuation of xx million USD through the forecast tenure till 2027, growing at a CAGR of xx% throughout the forecast span.For utmost reader convenience this elaborate research report on global Progenitor Cell Product market identifies 2019 as the base year and 2020-27 constitutes the overall forecast tenure, allowing precise market estimation about growth probabilities in the Progenitor Cell Product market.
Major Company Profiles operating in the Progenitor Cell Product Market:
NeuroNova ABR&D SystemsAsterias BiotherapeuticsStemCellsAxol BioReNeuron LimitedATCCSTEMCELL TechnologiesThermo Fisher ScientificLonzaIrvine ScientificCDI
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Unravelling Report Offerings Market:
1. A thorough and detailed analytical review of the Progenitor Cell Product market2. Brief about evident changes and market developments affecting market dynamics3. A clear understanding of market segmentation related to Progenitor Cell Product market4. A critical synopsis of all historical, real time as well as forecast developments likely to impact growth5. A systematic review of the diverse market developments and potent alterations that steer growth in the global Progenitor Cell Product market6. A reference of all the successful growth rendering developments
By the product type, the market is primarily split into:
Pancreatic progenitor cellsCardiac Progenitor CellsIntermediate progenitor cellsNeural progenitor cells (NPCs)Endothelial progenitor cells (EPC)Others
By the application, this report covers the following segments:
Medical careHospitalLaboratory
Owing to the sudden onset of global pandemic with the COVID-19 outrage in place, Orbis Pharma Reports analysts and dedicated research personnel have assigned a specific section evaluating the various implications and explaining the aftermath of the pandemic affecting diverse trends, developments as well as also categorically focusing on various opportunities emerging during the pandemic. The section is aimed at allowing market players to devise winning growth plans to secure profit even amidst the pandemic in Progenitor Cell Product market.
We are a team of young, mindful, agile research experts who pursue a fact-based approach to decode all relevant market specific information, required to harness superlative reader understanding about various marker facets that lead towards unhindered growth prognosis. Our flagship expertise in scavenging through various facets of market development and key perspectives are in place to unleash industry patterns to design and develop a future-ready market study that unravels information based on which report readers can well devise profit oriented business decisions that fetch highly profitable investment returns, favoring market participants.At Orbis Pharma Reports we categorically offer expert market research-oriented services across a heterogenous range of industrial participants, such as manufacturing companies, corporations, product development companies, who stand in greater need of market specific information.
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Covid-19 Impact on Global Progenitor Cell Product Market 2020 Industry Opportunities And Development Analysis 2026: NeuroNova AB,R&D Systems,Asterias...
David Shavelle, MD, Named Medical Director of Adult Cardiology for the MemorialCare Heart & Vascular Institute at Long Beach Medical Center -…
By daniellenierenberg
Dr. Shavelle, a Millikan High School (Long Beach, Calif.) graduate, is returning to Long Beach with more than 20 years of cardiology practice, research leadership, and teaching experience. He joins Long Beach Medical Center from Keck Medical Center at the University of Southern California, where he served as the Director of Interventional Cardiology while leading a multitude of clinical research trials, including several focused on implanted devices for heart failure. He plans on increasing the availability of clinical research trials for cardiology patients at Long Beach Medical Center.
"The MemorialCare Heart & Vascular Institute has a rich history of research and pioneering new treatment techniques," says Ike Mmeje, chief operating officer, Long Beach Medical Center.
"Dr. Shavelle's passion for research makes him a perfect fit to continue that legacy and find the next cutting-edge treatment for our cardiology patients."
MemorialCare Heart & Vascular Institute facilities are among the most comprehensive centers for diagnosis, treatment and rehabilitation of cardiac disease, providing groundbreaking care for complex heart conditions, including myocardial infarction, heart failure, arrhythmias and peripheral vascular disease. In addition to his hopes to expand research opportunities, Dr. Shavelle plans on expanding the programs for heart failure and structural heart disease.
"I am excited to join the MemorialCare Heart & Vascular Institute at Long Beach Medical Center," says Dr. Shavelle. "My dad was a physician here, and many of my mentors and fellows are at Long Beach Medical Center. I'm looking forward to creating more collaboration among cardiologists, surgeons, residents and the entire team to expand the already comprehensive cardiology care available to the community."
After earning his medical degree from the University of California, Los Angeles (UCLA), Dr. Shavelle completed his internal medicine internship and residency at Harbor-UCLA Medical Center. He completed General Cardiology Fellowship at the University of Washington and Interventional Cardiology Fellowship at Harbor-UCLA Medical Center/Good Samaritan Hospital. Dr. Shavelle served as Associate Professor at both the David Geffen School of Medicine at UCLA and the Keck School of Medicine at the University of Southern California. He alsoserveson the editorial boards for the Journal of Cardiovascular Pharmacology and Therapeutics, Current Medical Research and Opinion and Cardiology Clinics.
The MemorialCare Heart & Vascular Institute delivering nearly 20,000 cardiovascular diagnostic tests and treatments last year continues to push the boundaries of discovery with many "firsts." These began 70 years ago when world-renowned cardiologist, researcher and educator, the late Mervyn Ellestad, M.D., co-invented at Long Beach Medical Center the modern-day maximum stress test to detect heart disease. Today, millions of exercise stress tests performed annually save hundreds of thousands of lives globally.
"It is amazing how the field of cardiology has grown and how many treatment options are available through minimally invasive techniques," says Dr. Shavelle. "Many of these new treatment options have come from research trials, and I'm looking forward to expanding the opportunities for patients in the Long Beach area. The studies we have in the pipeline include trials with stem cells and heart failure devices."
About MemorialCare Long Beach Medical Center:MemorialCare Long Beach Medical Center has been providing the community with compassionate, quality health care for more than 100 years. While leading in specialized care, research and education, Long Beach Medical Center uses the most advanced health care technologies it is the only hospital in L.A. County with the innovative ExactechGPS and ExcelsiusGPS surgical systems. Long Beach Medical Center is ranked no. 7 in the Los Angeles Metro Area by U.S. News & World Report and has earned Magnet recognition for nursing excellence. With leading centers for cancer, heart, rehabilitation, orthopedics, neurology and trauma, physicians and surrounding hospitals continually refer to its accredited programs. For more information, visit memorialcare.org/LongBeach.
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David Shavelle, MD, Named Medical Director of Adult Cardiology for the MemorialCare Heart & Vascular Institute at Long Beach Medical Center -...
Tweet Chat Recap: Evaluating Treatment Approaches for Relapsed/Refractory DLBCL – Targeted Oncology
By daniellenierenberg
Targeted Oncology was joined by Kami J. Maddocks, MD, associate professor of clinical internal medicine, Division of Hematology, The Ohio State University Comprehensive Cancer CenterJames, for the discussion of a 76-year-old man with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in a recent tweet chat. In this case scenario, the patient presented with stage IV high-risk disease and received R-CHOP (Rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, prednisone), and radiotherapy.
Although the treatment appeared well-tolerated, the patient presented with similar symptoms as at diagnosis after completing 6 cycles with complete response to the therapy. According to the work-up, the patient is ineligible for transplant.
The patient was ineligible for stem cell transplantation (SCT), which Maddocks speculates may be due to the patients age, although other considerations could include comorbidities or intolerance to R-CHOP. Eligibility is the first thing she considers for her patients as it is currently the standard of care and the only curative approach for patients to receive salvage chemotherapy followed by consolidation with autologous SCT.
Maddocks told Targeted Oncology, In some patient cases, [the reason for ineligibility] is age even though there's no specific age cutoff, but we know that it's harder on the marrow as patients get older to collect stem cells and get that aggressive salvage chemotherapy. Patient comorbidities [can also impact eligibility], so heart conditions, lung conditions, renal insufficiency can be a problem. Performance status and then lastly, just if the patient had trouble getting to their initial chemotherapy with R-CHOP or had a lot of complications, then it's probably going to be harder for them to tolerate even more aggressive or intensive therapy.
In a twitter poll ahead of the chat, Targeted Oncology asked what the next best line of therapy for this patient might be, with 4 potential different treatment options. The option that drew the most attention, however, was the recently approved regimen of tafasitamab (Monjuvi) and lenalidomide (Revlimid).
Maddocks tweeted, All these options are potential therapeutic choices for this patient, but the combination of tafasitamab/lenalidomide is the only option approved in this setting. The treatment has a promising ORR [overall response rate], and CR [complete response], and the remissions for patients who respond are durable!
During the tweet chat, Maddocks reviewed each of the different treatment options in the poll, and why she selected this combination regimen as the next best line of therapy for this particular patient. Following the chat, she spoke with Targeted Oncology to share further insights on each of these therapeutic approaches and the importance of the FDAs approval of tafasitamab plus lenalidomide in this setting.
The combination of tafasitamab plus lenalidomide held the majority vote, which Maddocks agreed would be the next best line of therapy for this patient.
For patients who are not candidates or considered eligible for a salvage chemotherapy followed by autologous SCT, the tafasitamab/lenalidomide combination was recently approved in the setting of first relapse, and it's the only approved therapy in this setting, Maddocks said. Historically, we would give some sort of palliative chemotherapy approach if patients were candidates and interested in pursuing therapy, or consideration of clinical trial, but this is the only therapy approved in this setting.
The approval of tafasitamab in combination with lenalidomide includes an indication for patients who are not eligible for autologous SCT, as describes the patient in our case. This regimen was approved on the basis of the phase 2 L-MIND (NCT02399085) clinical trial, which explored this use of this regimen in 81 patients with relapsed/refractory DLBCL. Two-year follow-up demonstrated an ORR of 58.5%, which included CRs in 41.3% of patients and partial responses (PRs) in 17.5% of patients. In addition, 15.0% achieved stable disease, and the median duration of response was 34.6 months (95% CI, 26.1-34.6).1
I think this patient case is the perfect example of where this can fit into the treatment landscape, Maddocks explained. For patients who first relapse from the standard R-CHOP therapy, the toxicities were generally manageable, and with the response rate, this is a great option for patients at first relapse who are not going to be candidates for a transplant. I think maybe patients who go on to get palliative chemotherapy or maybe patients who get treatment with plans to go to transplant but just don't tolerate it and dont look like they're going to [undergo] aggressive therapy, this may be an option for those patients too, understanding that there is some role for CAR T in a set of those patients.
This study, which was presented during the 25th Congress of the European Hematology Association (EHA), demonstrated that the majority of toxicities were hematologic, and most were reversible. The most common grade 3 hematologic treatment-emergent adverse events (TEAEs) were neutropenia in 49.4% of patients, thrombocytopenia in 17.3%, and febrile neutropenia in 13.2%.1
These were able to be managed by holding the dose growth factor, and there was a population of patients who had to be dose-reduced on the lenalidomide. The starting dose was 25 mg, so the majority were able to maintain 20 mg if they were dose-reduced, although a few had to be reduced more than once, Maddocks said. The most common grade 3/4 or serious AEs were infection, probably not surprisingly, and overall, that's probably similar to what you see with other options in this setting. There was a small number of infusion reactions, but these were all grade 1 in the trial and were easily managed.
Non-hematologic TEAEs of grade 3 included pneumonia in 8.6% of patients and hypokalemia in 6.2%. Serious AEs reported included pneumonia in 8.6%, febrile neutropenia in 6.2%, and pulmonary embolism in 3.7%, as well as bronchitis, lower respiratory tract infection, atrial fibrillation, and congestive cardiac failure in 2.5% each.1
Given the safety profile of this combination of tafasitamab plus lenalidomide, this regimen is particularly suitable for a large proportion of patients with DLBCL, Gilles Salles, MD, PhD, lead author of L-MIND, toldTargeted Oncology. We do know that the median age of occurrence of DLBCL is in the late 60s, and there are many, many patients that are over 70 and that are not usually transplant eligible. Clearly this is a great opportunity for patients to receive this non-cytotoxic regimen.
Although this regimen is an exciting opportunity for patients with DLBCL and relapsed/refractory disease, 1 challenge that needs to be addressed is the potential use of tafasitamab plus lenalidomide in sequence with CAR T-cell therapy. There is very little experience, if any, of patients receiving the combination regimen after receiving CAR T-cell therapy. The combination and CAR T cells both target the same antigen, CD19, which can be problematic. As its known that some patients will lose CD19 expression on CAR T-cell therapy, the regimen may no longer be an effective treatment option.
For those patients that had failed CAR T-cell therapy, substantial proportions, about 30% of them, may have lost CD19 expression and then may not be eligible anymore for this regimen. There is, however, a substantial proportion of patients that retains CD19 and in whom tafasitamab/lenalidomide can be used as a treatment option, Salles commented.
A large proportion of patients will maintain CD19 expression following CAR T-cell therapy, so tafasitamab plus lenalidomide may still be effective in a percentage of patients.
Its hard to say because we dont have a lot of data, but we do know there are other CD19-directed therapies outside of CAR T cell development, Maddocks told Targeted Oncology. I think in the next few years, were going to see patients treated both pre- and post-CAR T with other CD19-directed therapies, and well have more information on this.
The combination of polatuzumab vedotin (Polivy) plus bendamustine (Bendeka) and rituximab (BR) was approved by the FDA as treatment of patients with relapsed/refractory DLBCL after 2 prior lines of therapy in June 2019 based on the findings from the phase 1b/2 GO29365 (NCT02257567) clinical trial. Although this option is also not FDA-approved for the treatment of patients after first relapse, Maddocks noted that this was the only treatment evaluated in a randomized trial. The study had included patients who were ineligible for transplant.
Significant improvements were observed with polatuzumab vedotin plus BR compared with BR alone in an international, multicenter, open-label study, particularly in regard to the ORR, CRs, progression-free survival (PFS), and overall survival (OS). CRs were observed in 40.0% of the patients with the combination versus 17.5% with BR alone. Survival rates favored the combination as well, with a median PFS of 9.5 months with the combination versus 3.7 months with BR alone (HR, 0.36; 95% CI, 0.21-0.63; P <.001) and a median OS of 12.4 months versus 4.7 months (HR, 0.42; 95% CI, 0.24-0.75; P =.002), respectively.2
The addition of polatuzumab did increase toxicity from the standpoint of cytopenias, but that didn't really translate to increased serious infections. It did add neuropathy as a side effect, but most of that was reversible, so I think this was a regimen that, by the addition of polatuzumab, was something that you could offer patients that did give them somewhat of a better overall response and was more durable than just giving them a palliative chemotherapy alone, Maddocks added. This is also a regimen that's been used in patients who were not able to achieve a remission to bridge them to CAR T or in some patients after CAR T, and so I can understand why this was definitely one of the more favorable choices.
In the study, grade 3/4 neutropenia was observed more frequently in the combination arm (42.6%) compared with the BR alone arm (33.3%), but the occurrence of grade 3/4 infections was comparable between the 2 groups (23.1% vs. 20.5%, respectively). In addition, the study authors noted that although many of the fatal AEs occurred after disease progression, 11 patients in the BR arm experienced fatal AEs compared with 9 in the combination arm, infection being the most common, which was the cause in 4 patients in each arm.2
Although the regimen appeared tolerable in this setting, Maddocks tweeted, it is more attractive than chemotherapy alone and understandable why it was chosen [as the second-best option in the Twitter poll].
Among the treatment options considered in our twitter poll ahead of the tweet chat, selinexor (Xpovio) only caught the attention of 16.7% of voters, similar to CAR T-cell therapy. However, both of these options are currently only approved in patients who have received at least 2 prior lines of therapy, which this case did not.
In regard to selinexor in particular, Maddocks tweeted, Looking at the single arm phase 2 data, it also has the lowest overall response rates of all the options listed with an ORR of 28%.
Selinexor received its approval from the FDA in June 2020, which is indicated for the treatment of adult patients with relapsed/refractory DLBCL, not otherwise specified, who have received at least 2 prior systemic therapies. This is the only oral single-agent therapy approved in this setting, and it is also the only nuclear export inhibitor approved by the FDA for use in hematologic malignancies.
The agent was approved on the basis of the phase 2b SADAL clinical trial, which demonstrated an ORR of 29% with 13% CRs and 16% PRs. The responses achieved in the study were durable, which led to a median duration of response of 9.2 months in the overall population (95% CI, 4.8-23.0) and 13.5 months in those who had achieved a CR (95% CI, 9.3-23.0).3
The most common treatment-related AEs were cytopenias and gastrointestinal/constitutional symptoms, which were generally reversible and manageable with dose modifications and/or standard supportive care approaches. The most common on-hematologic AEs, which were mostly grade 1/2, were nausea (52.8%), fatigue (37.8%), and anorexia (34.6%). The most common grade 3/4 AEs included thrombocytopenia (39.4%), neutropenia (20.5%), and anemia (13.4%). No treatment-related grade 5 AEs were observed.
CAR T-cell therapy, on the other hand, offers a unique option to this patient case even though it is still only approved in patients who have progressed or relapsed after 2 prior therapies or SCT. The TRANSCEND-PILOT-017006 (NCT03483103) study is evaluating the potential for CAR T-cell therapy lisocabtagene maraleucel (liso-cel) as treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma who have received at least 1 prior therapy and are ineligible for SCT. While this does appear promising for introducing CAR T-cell therapy earlier on for patients with DLBCL, the treatment is not available off trial and is not a standard approach.
Maddocks told Targeted Oncology, It's very clear who's eligible for autologous transplant by age and comorbidities, but with CAR T, it's not so clear all the time who is going to be a candidate. There's not as great of data or information on who is going to be a candidate for that or not. Probably more patients are going to be a candidate for transplant, but there is still going to be patients that are comorbidities that they're not going to be a candidate for CAR T cells, and while they're approved in this setting and they can be very effective, there's also logistical issues, including that right now there's only certain centers, most often transplant centers, that are able to administer CAR T cells, so the patient has to have access to a center, they have to be able to get through the time that their leukapheresis cells are sent out and then sent back, and there's still barriers to cost and insurance in some patients, too.
This particular patient case does represent a challenge, Maddocks said. Historically, this is not a patient that's going to be a candidate for an autologous SCT, and that's going to be the only curative approach. CAR T is not approved in this setting, which is the other curative approach we know outside of patients who are unable to get to autologous STC, or at least appears to be likely curative for a percentage of patients.
Overall, CAR T-cell therapy is not a viable treatment option for the patient depicted in our tweet chat discussion, although it can still offer curative opportunities to a select group of patients with DLBCL who are ineligible for transplant.
In conclusion, tafasitamab plus lenalidomide helps fulfill the unmet need of patients who are in first relapse but are ineligible for transplant, which is the only curative option for patients with relapsed/refractory DLBCL. Although CAR T cells appear hopeful in this space, more research needs to be done to further determine their role in the treatment paradigm.
When you look at relapsed DLBCL, in general, and have these options, it's exciting for our patients to be able to have these. All of these have come up in the last 1 to 2 years, CAR T being a little bit longer than the other 3 regimens, but they all have offered patients tolerable therapy in the setting of previously not having these options.
Reference
1. Salles G, Duell J, Gonzlez-Barca E, et al. Long-term outcomes from the phase II L-MIND study of Tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Presented at: Presented at: EHA25 Virtual; June 11-21, 2020. Abstract EP1201.
2. Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma.J Clin Oncol. 2019;38(2):155-165. doi: 10.1200/JCO.19.00172
3. Kalakonda N, Cavallo F, Follows G, et al. A phase 2b study of selinexor in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).Hematol Oncol. 2019;37(S2). doi: 10.1002/hon.31_2629
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Tweet Chat Recap: Evaluating Treatment Approaches for Relapsed/Refractory DLBCL - Targeted Oncology
How the coronavirus causes ‘carnage’ in the heart – The Daily Briefing
By daniellenierenberg
New research shows that the novel coronavirus can essentially dice the muscle fibers of the human heart into pieces, sparking concerns about the potential for heart failure among Covid-19 survivors, Elizabeth Cooney reports for STAT News.
Resources to support your CV telehealth strategy
For the study, which was published preprint on bioRxiv and has not yet been peer reviewed, researchers added the new coronavirus, SARS-CoV-2, to three types of human heart cellscardiomyocytes, cardiac fibroblasts, and endothelial cellsthat were grown in lab dishes from stem cells.
Only the cardiomyocytes, which are muscle cells, showed indication of viral infection that spread to other muscle cells, the researchers said. However, what they found in the infected cells was remarkable: The sarcomeres, which are the long muscle fibers that keep the heart beating, had been sliced into small bits. According to the researchers, the fibers looked as if they had been surgically sliced.
The researchers also found black holes where DNA was supposed to be in the nucleus of the infected cells. The researchers said they found similar, but not identical, changes when they observed autopsy specimens from patients with Covid-19, the disease caused by the novel coronavirus.
It's unclear whether the heart is able to reassemble the sarcomeres after they're severed, but that might be possible after the coronavirus infection clears, the researchers said. However, the researchers said they felt an urgency to share their results as quickly as possible, because their findings may help to further scientists' understanding of how the coronavirus causes heart damagesand possibly how to prevent or treat the injuries.
"When we saw this disruption in those microfibers that was when we made the decision to pull the trigger and put out this preprint," Todd McDevitt, a senior investigator at Gladstone Institutes and a co-author of the study, said. "I'm not a scientist who likes to stoke these things [but] I did not sleep, honestly, while we were finishing this paper and putting it out there."
Bruce Conklin, also a senior investigator at Gladstone and a co-author of the study, said the virus caused "carnage in the human cells" unlike anything seen with other diseases. "Nothing that we see in the published literature is like this in terms of this exact cutting and precise dicing," he explained.
Conklin said the findings should alter the way providers and scientists think about the novel coronavirus and Covid-19. "We should think about this as not only a pulmonary disease, but also potentially a cardiac one."
Gregg Fonarow, interim chief of the UCLA Division of Cardiology and director of the Ahmanson-UCLA Cardiomyopathy Center, said the study is "really important and elegant work, helping to define the potential mechanisms by which SARS-CoV-2 is leading to the observed heart damage and clinical manifestations."
Sahil Parikh, an interventional cardiologist at Columbia University Irving Medical Center, called findings "provocative," but added, "[t]he challenge here is that this paper has not been peer-reviewed by people who are experts in cardiology, who have not had a chance to tear it apart." She said, "I am reluctant to make a lot out of a pre-publication manuscript, no matter how provocative the finding."
The researchers who worked on the study agreed that their work should be reviewed, and they've submitted the study to a leading scientific journal (Cooney, STAT News, 9/4).
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How the coronavirus causes 'carnage' in the heart - The Daily Briefing
COVID-19 Drug Discovery and Development Why Diverse Strategies Are Critical – Technology Networks
By daniellenierenberg
There is no silver bullet at the moment, and there might never be, said World Health Organization Director-General Tedros Adhanom at a virtual press conference at the beginning of August. While it was this bleak sound bite that made the headlines, Tedros also had words of praise for the progress made towards identifying treatments that aid the recovery of COVID-19 patients with the most serious forms of the disease.Research towards treatments for COVID-19 has been developing at a phenomenal speed, even though it feels as though solutions cant come soon enough; the widespread transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has had significant health, economic and social impacts across the globe, and as of September 8th more than 27 million cases and 890,000 deaths have been recorded in 188 countries.
Research groups across the world have set about identifying drugs for the treatment of COVID-19, by screening both novel and existing drugs for their ability to alleviate symptoms and stem viral replication. Here, we provide an update on ongoing global efforts to develop and test drugs for the treatment of COVID-19 and explore the range of strategies being employed.
COVID-19 is a disease which can leave you with anything between a mild sniffle to an unpleasant combination of high fever, heavy fatigue, and lung inflammation and damage. The drivers of clinical symptoms can be roughly divided into two categories: the virus itself and the hyperinflammatory response to the virus that occurs in the most severely ill people. Consequently, efforts to identify appropriate treatments are often focused on one category, and sometimes, a particular patient group or stage of disease. Given the nature of COVID-19, it is highly likely that a combination of drugs (drug cocktail) will be needed to both neutralize the virus and suppress the symptoms of COVID-19. Antiviral treatments may target viral components directly, or other cellular processes involved in viral infection or replication. To date, interventional studies for COVID-19 have attempted to achieve a wide range of goals, including:
Addressing the threat of new and potentially life-threatening pathogens requires deep understanding and accurate, reproducible techniques for developing better tests, vaccines, and treatments. Agilent provides the complete breadth of systems, consumables, software, services, and knowledge you need to support your success.
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Meet the scientists on the frontline with coronavirus. Video credit: Sanford Burnham Prebys Medical Discovery Institute
Of the ~12,000 compounds screened, 100 inhibited SARS-CoV-2 replication in mammalian cells, 21 of which did so in a dose-response fashion. Achieving a sufficiently high dose concentration to elicit antiviral effects in vivo was predicted to be practical and possible for 13 of these compounds based on EC50 values in various cell lines. The most potent of these were evaluated for antiviral activity in human induced pluripotent stems cell (iPSC)-derived pneumocyte-like cells (five candidates) and in an ex vivo lung culture system (one candidate). The latter candidate is called apilimod, a small molecule inhibitor of an enzyme (phosphoinositide 5-kinase or PIKfyve, an endosomal lipid kinase) important to the endocytic pathway in which SARS-CoV-2 travels along during its journey through the cell. Encouragingly, apilimod potently antagonized viral replication in these tissues, and the findings are in agreement with those of another research group. This month, Kang et al. published an article in PNAS, describing the potent inhibition of SARS-CoV-2 by apilimod, providing further evidence to suggest PIKfyve-inhibition as a potential strategy that could limit infection and disease pathogenesis. The authors also noted that apilimod has passed safety tests in previous clinical trials for nonviral indications.
Chanda highlights the incredible pace at which this work was produced. Typically, a project like this would take years, rather than months. He points out that by wanting to do something quickly, there were sacrifices (and not just weekends). For example, they ran with the assay and the cell lines that allowed them to produce results quickly. This is the reason we put the entire dataset out there not one/three/20 molecules, we put all 100 molecules out there. These are the ones we found because of our experimental system, but please keep testing the others because youll probably find other things that work, said Chanda.
To design multiple peptide sequences that can competitively bind to the SARS-CoV-2 receptor binding domain, the University of Michigan research group used a protein design system called EvoDesign.EvoDesign is the first de novo protein design protocol developed in our lab; it performs design simulation by combining the evolution-based information collected from protein databases and an accurate physics- and knowledge-based energy function, namely EvoEF2, for computing atomic interactions such as van der Waals forces, electrostatics, hydrogen bonding, and desolvation energies, said Huang.
Overall, these sophisticated computational tools represent a promising new avenue for the de novo development of drug discovery studies.
Read more:
COVID-19 Drug Discovery and Development Why Diverse Strategies Are Critical - Technology Networks
Global and Asia Pacific Progenitor Cell Product Market to Witness Huge Growth by 2027 Major Manufacturers included in report NeuroNova AB, StemCells,…
By daniellenierenberg
Global Coronavirus pandemic has impacted all industries across the globe, Progenitor Cell Product market being no exception. As Global economy heads towards major recession post 2009 crisis, Cognitive Market Research has published a recent study which meticulously studies impact of this crisis on Global Progenitor Cell Product market and suggests possible measures to curtail them. This press release is a snapshot of research study and further information can be gathered by accessing complete report. To Contact Research Advisor Mail us @ [emailprotected] or call us on +1-312-376-8303.
Report is a detailed study of the Progenitor Cell Product market, which covers all the essential information required by a new market entrant as well as the existing players to gain a deeper understanding of the market. Report has been segmented into Geographical Segmentation, Key players, Key Topics Industry Value and Demand Analysis Forecast to 2027 and provides comprehensive investigation.
Global Progenitor Cell Product Market: Product analysis: Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others
Global Progenitor Cell Product Market: Application analysis: Medical care, Hospital, Laboratory
Major Market Players with an in-depth analysis: NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI
Any query? Enquire Here For Discount (COVID-19 Impact Analysis Updated Sample): Click Here>Download Sample Report of Progenitor Cell Product Market Report 2020 (Coronavirus Impact Analysis on Progenitor Cell Product Market)
The research comprises primary information about the products. Similarly, it includes supply-demand statistics, and segments that constrain the growth of an industry. It also includes raw materials used and manufacturing process of Progenitor Cell Product market. Additionally, report provides market drivers and challenges & opportunities for overall market in the particular provincial sections.
The report gives detailed account on each segment which helps to understand market more effectively. The company profiling of key players include: business overview, product description, research and development investment, key development, business strategy, and SWOT analysis. It also involves sales revenue of each division and geographical coverage for two consecutive years.
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The industry intelligence study of the Progenitor Cell Product market covers the estimation size of the market each in phrases of value (Mn/Bn USD) and volume (x units). Further, report consists of Porters Five Forces and BCG matrix as well as product life cycle to help you in taking wise decisions. Additionally, this report covers the inside and out factual examination and the market elements and requests which give an entire situation of the business.
Regional Analysis for Progenitor Cell Product Market:North America (United States, Canada)Europe (Germany, Spain, France, UK, Russia, and Italy)Asia-Pacific (China, Japan, India, Australia, and South Korea)Latin America (Brazil, Mexico, etc.)The Middle East and Africa (GCC and South Africa)
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Market Growth of Global Stem Cells to Remain Sluggish through 2020 2030 – The News Brok
By daniellenierenberg
The success of approved stem cell therapies has caused a surge in interest of biopharma developers in this field; many innovator companies are currently progressing proprietary leads across different phases of clinical development, with cautious optimism
Roots Analysis has announced the addition of Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent)) report to its list of offerings.
There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.
To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link
Over 280 stem cell therapies are under development, most of which are allogeneic productsMore than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.
70% of pipeline candidates are based on mesenchymal stem cellsIt is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.
Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regionsWithin these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies
Over 1,500 grants were awarded for stem cell research, since 2015More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.
Outsourcing has become indispensable to R&D and manufacturing activity in this domainPresently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.
North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.
To request a sample copy / brochure of this report, please visit this link
The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:
The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:
The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.
For additional details, please visithttps://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html
or email [emailprotected]
You may also be interested in the following titles:
Contact:
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Market Growth of Global Stem Cells to Remain Sluggish through 2020 2030 - The News Brok
New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck’s Commitment to Advancing Cancer Research and Care – The Baytown Sun
By daniellenierenberg
KENILWORTH, N.J.--(BUSINESS WIRE)--Sep 2, 2020--
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its broad and diverse oncology development program will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from Sept. 1921. Data spanning more than 15 types of cancer will be presented at the congress, with new findings from Mercks portfolio of established medicines including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (lenvatinib, in collaboration with Eisai); and LYNPARZA (in collaboration with AstraZeneca). Pivotal Phase 3 data evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer from the KEYNOTE-590 trial (Abstract #LBA8) and LYNPARZA in patients with metastatic castration-resistant prostate cancer (mCRPC) from the PROfound trial (Abstract #610O) were selected for inclusion in ESMO Presidential Symposium sessions. Additionally, new findings will be shared for three of Mercks novel investigational candidates: vibostolimab (MK-7684), an anti-TIGIT antibody; MK-4830, an antibody targeting ILT4; and MK-6482, an oral HIF-2 inhibitor.
At Merck, we are focused on further improving long-term outcomes for more patients living with cancer, and this commitment is reflected in the breadth and diversity of our oncology research program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. At the ESMO Virtual Congress 2020, we look forward to sharing important new results including survival data for KEYTRUDA in esophageal cancer and long-term findings in lung cancer, melanoma, and head and neck cancer, as well as research from our expansive pipeline.
Key data from Mercks portfolio and pipeline to be presented at ESMO include:
KEYTRUDA
KEYTRUDA Plus LENVIMA
LYNPARZA
Pipeline
Merck Investor Event
Merck will hold a virtual investor event in conjunction with the ESMO Virtual Congress 2020 on Tuesday, Sept. 22 from 89 a.m. E.T. Details will be provided at a date closer to the event at https://www.merck.com/investor-relations.
Details on Abstracts Listed Above and Additional Key Abstracts for Merck
KEYTRUDA
Classical Hodgkin Lymphoma
Colorectal Cancer
Diffuse Large B-Cell Lymphoma
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Melanoma
Sarcoma
Solid Tumors
KEYTRUDA Plus LENVIMA (in collaboration with Eisai)
Lung Cancer
Melanoma
Renal Cell Carcinoma
Solid Tumors
LYNPARZA (in collaboration with AstraZeneca)
Ovarian Cancer
Prostate Cancer
Vibostolimab
Lung Cancer
MK-4830
Solid Tumors
MK-6482
Von-Hippel Lindau Disease
About KEYTRUDA (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA (pembrolizumab) Indications
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Small Cell Lung Cancer
KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Endometrial Carcinoma
KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 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 trial.
Tumor Mutational Burden-High
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Selected Important Safety Information for KEYTRUDA
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.
Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)
Immune-Mediated Hepatitis
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hepatotoxicity in Combination With Axitinib
KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.
Immune-Mediated Endocrinopathies
KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.
Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.
Immune-Mediated Nephritis and Renal Dysfunction
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.
Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 – StartupNG
By daniellenierenberg
The Plasma Therapy market research report added by Market Study Report, LLC, is an in-depth analysis of the latest trends persuading the business outlook. The report also offers a concise summary of statistics, market valuation, and profit forecast, along with elucidating paradigms of the evolving competitive environment and business strategies enforced by the behemoths of this industry.
The Plasma Therapy market report provides with a broad perspective of this business space and contains crucial insights such as current and predicted remuneration of the industry, in consort with its size and valuation over the estimated timeframe.
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The study assesses the key factors that are positively affecting the industry landscape based on revenue generated as well as market growth. Additionally, the document analyzes the current trends that define this market while evaluating the challenges & limitations as well as the growth factors of this domain.
Key aspects of Plasma Therapy market report:
Regional analysis of Plasma Therapy market:
Plasma Therapy Market Segmentation:
Product types and application scope of Plasma Therapy market:
Product landscape:
Product types:
Key factors highlighted in the report:
Application Landscape:
Application segmentation:
Details specified in the document:
Additional information enlisted in the document:
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Competitive arena of the Plasma Therapy market:
Key players in the Plasma Therapy market:
Major aspects enlisted in the report:
Report Objectives:
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Plasma Therapy Regional Market Analysis
Plasma Therapy Segment Market Analysis (by Type)
Plasma Therapy Segment Market Analysis (by Application)
Plasma Therapy Major Manufacturers Analysis
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Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 - StartupNG
Stem Cell Therapy Market Scope and Opportunities Analysis 2017 2025 – StartupNG
By daniellenierenberg
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:
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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.
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Stem Cell Therapy Market Scope and Opportunities Analysis 2017 2025 - StartupNG
Keio University gets OK for iPS-based heart cell transplant plan – The Japan Times
By daniellenierenberg
A health ministry panel on Thursday approved a Keio University clinical research project to transplant heart muscle cells made from induced pluripotent stem (iPS) cells into heart disease patients.
The research will be carried out by a team led by Prof. Keiichi Fukuda for three people between 20 and 74 suffering from dilated cardiomyopathy, which lowers the hearts power to pump blood. The first transplant will be conducted by the end of this year at the earliest.
The team will use iPS cells made by Kyoto University from the blood of a person who has a special immunological type with less risk of rejection.
The team will transform the iPS cells into heart muscle cells and inject about 50 million of them into the heart using a special syringe. Immunosuppressive drugs will be used for about half a year, and the team will spend a year checking to see whether the treatment leads to the development of tumors and irregular heartbeat or whether it restores heart function.
In January, Osaka University conducted the worlds first transplant of heart muscle cells made from iPS cells. The heart muscle cells were made into sheets and pasted on the surface of the patients heart so that a substance they emit can help regenerate the heart muscles. The cells themselves, however, disappear quickly.
Meanwhile, Keio University has confirmed in an experiment on monkeys that cells colonize after a transplant and heart function improves.
The university expects that transplanted cells will colonize over a long period also in the upcoming clinical research project.
According to the team, there are about 25,000 dilated cardiomyopathy patients in Japan.
A startup led by Fukuda is planning a clinical trial aimed at commercializing the iPS-derived cells, hoping they will also be used for the treatment of other cardiac diseases.
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Keio University gets OK for iPS-based heart cell transplant plan - The Japan Times
Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) – Galus Australis
By daniellenierenberg
Global Stem Cell Reconstructive Marketwas valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 24.5% during a forecast period.
Market Dynamics
The Research Report gives an in-depth account of the drivers and restraints in the stem cell reconstructive market. Stem cell reconstructive surgery includes the treatment of injured or dented part of body. Stem cells are undifferentiated biological cells, which divide to produce more stem cells. Growing reconstructive surgeries led by the rising number of limbs elimination and implants and accidents are boosting the growth in the stem cell reconstructive market. Additionally, rising number of aged population, number of patients suffering from chronic diseases, and unceasing development in the technology, these are factors which promoting the growth of the stem cell reconstructive market. Stem cell reconstructive is a procedure containing the use of a patients own adipose tissue to rise the fat volume in the area of reconstruction and therefore helping 3Dimentional reconstruction in patients who have experienced a trauma or in a post-surgical event such as a mastectomy or lumpectomy, brain surgery, or reconstructive surgery as a result of an accident or injury. Stem cell reconstructive surgeries are also used in plastic or cosmetic surgeries as well. Stem cell and regenerative therapies gives many opportunities for development in the practice of medicine and the possibility of an array of novel treatment options for patients experiencing a variety of symptoms and conditions. Stem cell therapy, also recognised as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.
The common guarantee of all the undifferentiated embryonic stem cells (ESCs), foetal, amniotic, UCB, and adult stem cell types is their indefinite self-renewal capacity and high multilineage differentiation potential that confer them a primitive and dynamic role throughout the developmental process and the lifespan in adult mammal.However, the high expenditure of stem cell reconstructive surgeries and strict regulatory approvals are restraining the market growth.
The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.
Global Stem Cell Reconstructive Market Segment analysis
Based on Cell Type, the embryonic stem cells segment is expected to grow at a CAGR of XX% during the forecast period. Embryonic stem cells (ESCs), derived from the blastocyst stage of early mammalian embryos, are distinguished by their capability to distinguish into any embryonic cell type and by their ability to self-renew. Owing to their plasticity and potentially limitless capacity for self-renewal, embryonic stem cell therapies have been suggested for regenerative medicine and tissue replacement after injury or disease. Additionally, their potential in regenerative medicine, embryonic stem cells provide a possible another source of tissue/organs which serves as a possible solution to the donor shortage dilemma. Researchers have differentiated ESCs into dopamine-producing cells with the hope that these neurons could be used in the treatment of Parkinsons disease. Upsurge occurrence of cardiac and malignant diseases is promoting the segment growth. Rapid developments in this vertical contain protocols for directed differentiation, defined culture systems, demonstration of applications in drug screening, establishment of several disease models, and evaluation of therapeutic potential in treating incurable diseases.
Global Stem Cell Reconstructive Market Regional analysis
The North American region has dominated the market with US$ XX Mn. America accounts for the largest and fastest-growing market of stem cell reconstructive because of the huge patient population and well-built healthcare sector. Americas stem cell reconstructive market is segmented into two major regions such as North America and South America. More than 80% of the market is shared by North America due to the presence of the US and Canada.
Europe accounts for the second-largest market which is followed by the Asia Pacific. Germany and UK account for the major share in the European market due to government support for research and development, well-developed technology and high healthcare expenditure have fuelled the growth of the market. This growing occurrence of cancer and diabetes in America is the main boosting factor for the growth of this market.
The objective of the report is to present a comprehensive analysis of the Global Stem Cell Reconstructive Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.
The report also helps in understanding Global Stem Cell Reconstructive Market dynamics, structure by analysing the market segments and projects the Global Stem Cell Reconstructive Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Stem Cell Reconstructive Market make the report investors guide.Scope of the Global Stem Cell Reconstructive Market
Global Stem Cell Reconstructive Market, By Sources
Allogeneic Autologouso Bone Marrowo Adipose Tissueo Blood Syngeneic OtherGlobal Stem Cell Reconstructive Market, By Cell Type
Embryonic Stem Cell Adult Stem CellGlobal Stem Cell Reconstructive Market, By Application
Cancer Diabetes Traumatic Skin Defect Severe Burn OtherGlobal Stem Cell Reconstructive Market, By End-User
Hospitals Research Institute OthersGlobal Stem Cell Reconstructive Market, By Regions
North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Stem Cell Reconstructive Market
Osiris Therapeutics NuVasives Cytori Therapeutics Takeda (TiGenix) Cynata Celyad Medi-post Anterogen Molmed Baxter Eleveflow Mesoblast Ltd. Micronit Microfluidics TAKARA BIO INC. Tigenix Capricor Therapeutics Astellas Pharma US, Inc. Pfizer Inc. STEMCELL Technologies Inc.
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Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) - Galus Australis
First lab-made ‘mini-hearts’ mimic the real thing – Futurity: Research News
By daniellenierenberg
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Researchers have created, for the first time, a miniature human heart model in the laboratory.
The mini-hearts are complete with all primary heart cell types and a functioning structure of chambers and vascular tissue.
The organoids are small models of the fetal heart with representative functional and structural features. They are, however, not as perfect as a human heart yet. That is something we are working toward.
These mini-hearts constitute incredibly powerful models in which to study all kinds of cardiac disorders with a degree of precision unseen before, says Aitor Aguirre, assistant professor of biomedical engineering at Michigan State Universitys Institute for Quantitative Health Science and Engineering and senior author of the study on the work on the bioRxiv preprint server. In the United States, heart disease is the leading cause of death.
The researchers created the human heart organoids, or hHOs for short,by way of a novel stem cell framework that mimics the embryonic and fetal developmental environments.
Organoidsmeaning resembling an organare self-assembling 3D cell constructs that recapitulate organ properties and structure to a significant extent, says first author Yonatan Israeli, a graduate student in Aguirres lab.
The innovation deploys a bioengineering process that uses induced pluripotent stem cellsadult cells from a patient to trigger embryonic-like heart development in a dishgenerating a functional mini-heart after a few weeks. The stem cells are obtained from consenting adults and therefore free of ethical concerns.
This process allows the stem cells to develop, basically as they would in an embryo, into the various cell types and structures present in the heart, Aguirre says. We give the cells the instructions and they know what they have to do when all the appropriate conditions are met.
Because the organoids followed the natural cardiac embryonic development process, the researchers studied, in real time, the natural growth of an actual fetal human heart.
This technology allows for the creation of numerous hHOs simultaneously with relative ease, contrasting with existing tissue engineering approaches that are expensive, labor intensive and not readily scalable.
One of the primary issues facing the study of fetal heart development and congenital heart defects is access to a developing heart. Researchers have been confined to the use of mammalian models, donated fetal remains, and in vitro cell research to approximate function and development.
Now we can have the best of both worlds, a precise human model to study these diseasesa tiny human heartwithout using fetal material or violating ethical principles. This constitutes a great step forward, Aguirre says.
Whats next? For Aguirre, the process is twofold. First, the heart organoid represents an unprecedented look into the nuts and bolts of how a fetal heart develops.
In the lab, we are currently using heart organoids to model congenital heart diseasethe most common birth defect in humans affecting nearly 1% of the newborn population, Aguirre says. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.
And second, while the hHO is complex, it is far from perfect. For the team, improving the final organoid is another key avenue of future research.
The organoids are small models of the fetal heart with representative functional and structural features, Israeli says. They are, however, not as perfect as a human heart yet. That is something we are working toward.
The researchers are excited about the wide-ranging applicability of these miniature hearts. They enable an unprecedented ability to study many other cardiovascular-related diseasesincluding chemotherapy-induced cardiotoxicity and the effect of diabetes, during pregnancy, on the developing fetal heart.
Additional researchers from Michigan State and Washington University in St. Louis contributed to the work.
The American Heart Association and the National Institutes of Health funded the study.
Source: Michigan State University
Original Study DOI: 10.1101/2020.06.25.171611
Original post:
First lab-made 'mini-hearts' mimic the real thing - Futurity: Research News
Scientists grow the first functioning mini human heart model – MSUToday
By daniellenierenberg
Michigan State University researchers have created for the first time a miniature human heart model in the laboratory, complete with all primary heart cell types and a functioning structure of chambers and vascular tissue.
Aitor Aguirre, assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering.
These minihearts constitute incredibly powerful models in which to study all kinds of cardiac disorders with a degree of precision unseen before, said Aitor Aguirre, the studys senior author and assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering.
This study, Generation of Heart Organoids Modeling Early Human Cardiac Development Under Defined Conditions, appears on the bioRxiv preprint server and was funded by grants from the American Heart Association and the National Institutes of Health. In the United States, heart disease is the No. 1 cause of death.
The human heart organoids, or hHOs for short, were created by way of a novel stem cell framework that mimics the embryonic and fetal developmental environments.
Organoids meaning resembling an organ are self-assembling 3D cell constructs that recapitulate organ properties and structure to a significant extent, said Yonatan Israeli, a graduate student in the Aguirre Lab and first author of the study.
The innovation deploys a bioengineering process that uses induced pluripotent stem cells adult cells from a patient to trigger embryonic-like heart development in a dish generating a functional mini heart after a few weeks. The stem cells are obtained from consenting adults and therefore free of ethical concerns.
This process allows the stem cells to develop, basically as they would in an embryo, into the various cell types and structures present in the heart, Aguirre said. We give the cells the instructions and they know what they have to do when all the appropriate conditions are met.
Because the organoids followed the natural cardiac embryonic development process, the researchers studied, in real time, the natural growth of an actual fetal human heart.
This technology allows for the creation of numerous hHOs simultaneously with relative ease, contrasting with existing tissue engineering approaches that are expensive, labor intensive and not readily scalable.
One of the primary issues facing the study of fetal heart development and congenital heart defects is access to a developing heart. Researchers have been confined to the use of mammalian models, donated fetal remains and in vitro cell research to approximate function and development.
Now we can have the best of both worlds, a precise human model to study these diseases a tiny human heart without using fetal material or violating ethical principles. This constitutes a great step forward, Aguirre said.
Whats next? For Aguirre, the process is twofold. First, the heart organoid represents an unprecedented look into the nuts and bolts of how a fetal heart develops.
In the lab, we are currently using heart organoids to model congenital heart disease the most common birth defect in humans affecting nearly 1% of the newborn population, Aguirre said. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.
And second, while the hHO is complex, it is far from perfect. For the team, improving the final organoid is another key avenue of future research. The organoids are small models of the fetal heart with representative functional and structural features, Israeli said. They are, however, not as perfect as a human heart yet. That is something we are working toward.
Aguirre and team are excited about the wide-ranging applicability of these miniature hearts. They enable an unprecedented ability to study many other cardiovascular-related diseases from chemotherapy-induced cardiotoxicity to the effect of diabetes, during pregnancy, on the developing fetal heart.
Other researchers involved in this study were Aaron Wasserman, Mitchell Gabalski and Kristen Ball at MSU; and Chao Zhou, Jinyon Zhou and Guangming Ni at Washington University in St. Louis.
(Note for media: Please include a link to the original paper in online coverage: https://www.biorxiv.org/content/10.1101/2020.06.25.171611v2)
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Scientists grow the first functioning mini human heart model - MSUToday