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

By daniellenierenberg

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

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

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

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

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

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

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June 17th, 2020

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

By daniellenierenberg

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

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

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

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Market Dynamics:

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

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

Global Human Embryonic Stem Cell Research Methodology

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

Major Drivers and Restraints of the Human Embryonic Stem Cell Industry

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

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

By Type

By Application

By End User

Top Players in the Market are:

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

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

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

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

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

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Some of the Major Highlights of TOC covers:

Chapter 1: Methodology & Scope

Definition and forecast parameters

Methodology and forecast parameters

Data Sources

Chapter 2: Executive Summary

Business trends

Regional trends

Product trends

End-use trends

Chapter 3: Human Embryonic Stem Cell Industry Insights

Industry segmentation

Industry landscape

Vendor matrix

Technological and innovation landscape

Chapter 4: Human Embryonic Stem Cell Market, By Region

Chapter 5: Company Profile

Business Overview

Financial Data

Product Landscape

Strategic Outlook

SWOT Analysis

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

About Data Bridge Market Research:

An absolute way to forecast what future holds is to comprehend the trend today!Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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

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June 17th, 2020

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

By daniellenierenberg

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

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

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

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

Development of Advanced Treatment Method Augmenting Market Growth

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

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

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

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

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

Dermatology Segment Holds Prominence in Stem Cell Therapy Market

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

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

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

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

About TMR Research

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

Contact:TMR Research,3739 Balboa St # 1097,San Francisco, CA 94121United StatesTel: +1-415-520-1050Visit Site: https://www.tmrresearch.com/

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June 16th, 2020

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

By daniellenierenberg

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

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

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

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

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

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

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

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

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June 15th, 2020

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

By daniellenierenberg

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

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

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

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Segmental Analysis

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

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

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

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

, Medical care, Hospital, Laboratory

Competitive Landscape

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

Key questions answered in the report:

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TOC

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

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June 14th, 2020

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

By daniellenierenberg

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Development of Advanced Treatment Method Augmenting Market Growth

Dermatology Segment Holds Prominence in Stem Cell Therapy Market

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

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June 13th, 2020

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

By daniellenierenberg

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

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

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

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

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

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

HGB-206: Group C Updated Efficacy Results

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

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

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

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

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

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

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

HGB-206: Group C Safety Results

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

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

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

About HGB-206

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

LentiGlobin for Sickle Cell Disease Regulatory Status

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

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

About LentiGlobin for Sickle Cell Disease

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

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

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

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

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

About bluebird bio, Inc.

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

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

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

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

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

bluebird bio Forward-Looking Statements

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

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June 13th, 2020

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

By daniellenierenberg

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

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

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

Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

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

Allogeneic Stem Cells Autologous Stem cells

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

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June 13th, 2020

The Country Is Reopening. Im Still on Lockdown – WIRED

By daniellenierenberg

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

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

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

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

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

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

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

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

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

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

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

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

By daniellenierenberg

Progenitor Cell Product Market Global and Outlook (2016 2026)

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

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

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

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

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

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

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Progenitor Cell Product Market Regional Analysis

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

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

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

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

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

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

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

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

The main questions given in the report include:

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

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

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

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June 13th, 2020

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

By daniellenierenberg

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

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

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

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

Parent Indicators Healthcare

Research Methodology

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

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

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

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

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

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

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Market Taxonomy

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

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

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June 12th, 2020

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

By daniellenierenberg

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

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

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

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

Michael Schumacher. Photo skysports.com

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

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

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June 10th, 2020

Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients…

By daniellenierenberg

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-361 trial evaluating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with advanced or metastatic urothelial carcinoma (bladder cancer) did not meet its pre-specified dual primary endpoints of overall survival (OS) or progression-free survival (PFS), compared with standard of care chemotherapy. In the final analysis of the study, there was an improvement in OS and PFS for patients treated with KEYTRUDA in combination with chemotherapy (cisplatin or carboplatin plus gemcitabine) compared to chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The monotherapy arm of the study was not formally tested, since superiority was not reached for OS or PFS in the KEYTRUDA combination arm. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies, and no new safety signals were identified. Results will be presented at an upcoming medical meeting and will be discussed with regulatory authorities.

In this study, KEYTRUDA in combination with chemotherapy in previously untreated patients with advanced or metastatic bladder cancer was rigorously tested against an active control of the current standard of care chemotherapy combination regimen, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. While we are disappointed in these study results, KEYTRUDA has been established as an important option in the treatment of metastatic bladder cancer, and we are committed to continuing our research to help more patients with this disease. We are grateful to the patients and investigators for their participation in this study.

KEYTRUDA has three FDA-approved bladder cancer indications across multiple types and stages of bladder cancer. Additionally, Merck has an extensive clinical development program in bladder cancer and is continuing to evaluate KEYTRUDA as monotherapy and in combination with other anti-cancer therapies across several disease settings (i.e., metastatic, muscle invasive bladder cancer, and non-muscle invasive bladder cancer).

About KEYNOTE-361

KEYNOTE-361 (ClinicalTrials.gov, NCT02853305) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma. The dual primary endpoints are OS and PFS. Secondary endpoints include duration of response, disease control rate, overall response rate and safety. The study enrolled 1,010 patients who were randomized to receive:

About Bladder Cancer

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumor and spread to other areas of the body. Urothelial carcinoma, the most common type of bladder cancer, starts in the urothelial cells that line the inside of the bladder. It is estimated there were more than 549,000 new cases of bladder cancer and nearly 200,000 deaths from the disease globally in 2018. In the United States, it is estimated there will be more than 81,000 new cases of bladder cancer and nearly 18,000 deaths from the disease in 2020. The five-year survival rate for advanced or metastatic bladder cancer (stage IV) is estimated to be approximately 5%.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

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

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

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

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

Head and Neck Squamous Cell Cancer

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

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

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

Classical Hodgkin Lymphoma

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

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Carcinoma

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

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

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

Microsatellite Instability-High (MSI-H) Cancer

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

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

Gastric Cancer

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

Esophageal Cancer

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

Cervical Cancer

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

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

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

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

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

Other Immune-Mediated Adverse Reactions

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

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

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

Infusion-Related Reactions

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

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

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

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

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

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

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Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients...

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June 10th, 2020

Nanion Technologies and Nexel Partner to Open a New Reference Demonstration Laboratory in South Korea – Labmate Online

By daniellenierenberg

Nanion Technologies and Nexel are pleased to announce a partnership, focused on combining Nanions CardioExcyte 96 and FLEXcyte 96 cell monitoring technology with Nexels hiPSC-derived cells for demonstration purposes. Bringing together the two companies infrastructure and expertise serves to meet the growing demand for a reliable, high throughput cell monitoring technology in Asia.

The Nanion- Nexel partnership brings together profound skills in comprehensivein vitroelectrophysiology technology and development of human induced pluripotent stem cells (hiPSCs), with focus on cardiomyocytes. Under the partnership, Nexel opens a reference demonstration laboratory for Nanions systems at Nexels headquarters in Seoul, whereby both companies aim to significantly upscale support of their clients in Asia.

Dr Choong-Seong Han, CEO of Nexel, said: Nexel is proud to start this partnership with Nanion Technologies. We believe it will further build on the excellent relationship we have developed together in the last year. The Cardiosight-S cardiomyocytes have been fully validated on the CardioExcyte 96 and FLEXcyte 96 systems and our expert scientists are dedicated to provide the best demo settings as well as product experience for customers, as part of the collaboration. We hope interest in both Nanions and Nexels offerings will increase with our collaborative efforts.

Frank Henrichsen, Director of Global Sales of Nanion Technologies added: We are very eager to strengthen our position in the Asian market and especially in Korea. In Nexel, we see a valuable partner to help us develop our presence, in this case through opening their laboratories and enabling the use Nanions technology for demo purposes at their premises. Combining Nexels hiPSC-derived cardiomyocytes and cardiacin vitroassays with Nanions CardioExcyte 96 and FLEXcyte 96 systems, we are confident that our customers will get an excellent package solution for use in safety pharmacology and toxicology assays. We are also very happy that Nexel has already implemented the systems into their quality control procedure of Cardiosight-S cardiomyocytes.

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June 10th, 2020

Who’s to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal – Science Magazine

By daniellenierenberg

By Charles PillerJun. 8, 2020 , 7:00 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

Three unlikely collaborators are at the heart of the fast-moving COVID-19 research scandal, which led to retractions last week by The Lancet and The New England Journal of Medicine (NEJM), and the withdrawal of an online preprint, after the trove of patient data they all relied on was challenged. The three physician-scientists never were at the same institution nor had they ever before written together, but they are the only authors in common on the disputed papers, and the other co-authors all have ties to at least one of them. Their partnership, which seized a high-impact role during a global public health crisis, has now ended disastrously.

The first author for both retracted papers was cardiac surgeon Mandeep Mehra, an eminent Harvard University professor who works at Brigham and Womens Hospital (BWH) and is known internationally for cardiovascular medicine and heart transplants. He provided the kind of gravitas that can fast-track papers to leading journals. In a statement provided by BWH, Mehra said he had met another of the trio, cardiac surgeon Amit Patel, in academic and medical circles, and that Patel had introduced him to Sapan Desai, a vascular surgeon and founder of Surgisphere, the tiny company that supplied the data. Journal disclosures, however, also indicate Mehra received compensation from Triple-Gene, a gene therapy company Patel co-founded to develop cardiovascular treatments.

Desai publicly aspired to combine big data and artificial intelligence (AI) in ways that he said can replace randomized controlled clinical trials. For a brief moment, it seemed that Surgispheres enticing data set, said to include nearly 100,000 detailed patient records from about 700 hospitals on six continents, would settle questions about the possible benefits of various drugsincluding the controversial antimalarial hydroxychloroquinefor COVID-19 patients.

Patel once apparently headed cardiac surgery at the University of Miami Miller School of Medicine. A university press release announcing his arrival in 2016 is no longer posted on the university website, however, and the school has not confirmed his job duties there. More recently, he has been a volunteer adjunct professor at the University of Utah. But, as STAT first reported yesterday, Patel tweeted on Friday that he had severed his relationship with the university, which a school spokesperson confirmed. In recent years Patel has developed and commercialized experimental stem cell therapies purported to cure heart problems, reverse aging, or treat sexual dysfunction. He is also part of a network of physicians that just launched a trial to use stem cells from umbilical cord blood to treat COVID-19 patients.

Normally co-authors of high-profile papers share subject area expertise or have clear professional ties, says Jerome Kassirer, chief editor ofNEJMduring the 1990s. He calls the collaboration of the apparently disparate individuals completely bizarre, and a red flag that the studies warranted intensive scrutiny that the journals failed to provide.

None of the three co-authors responded to requests for comment. Patel spoke with aSciencereporter initially but said he wanted to wait for audits of the Surgisphere data to comment, and Desais spokesperson stopped communicating after the retractions. Still, interviews with former colleagues and a long paper trail shed some light on each of them.

Desai had a history of convincing respected researchers of his skill and integrity. One of them, Gilbert Upchurch, department of surgery chair at the University of Florida, wrote last year in a journal commentary that he had never met Desai but had nonetheless mentored him remotely and developed an online friendship with him. Upchurch placed the scientist in a group of amazing and talented young vascular surgeons.

Illinois court records show Desai is facing two medical malpractice lawsuits filed last year. He told The Scientist that he deems any lawsuit naming him to be unfounded.

Desai has a history of big aspirations and entrepreneurial venturessome short-lived. His science-fiction blog, corewardfront.com, was meant to find the most parsimonious route for mankind to establish a meaningful presence in space. In 2009, he wrote that the site would publish fiction grounded in facts and reality, adding, the scientific method must be followed religiously. The blog is no longer published.

As a student, Desai won several small National Institutes of Health (NIH) grants for studies of the vestibular system. He started Surgisphere in 2007, when he was a medical resident at Duke University. Surgispheres initial products were medical guides and textbooks, although Desai has said he was working on big data projects for the company from its birth. In 2010, under the firms auspices, he founded the Journal of Surgical Radiologywhose editors included researchers with well-established publishing records. It folded in January 2013. Articles from the journal were cited only 29 times in its history, according to Scimago, a journal rating service. Yet an undated Surgisphere web page, no longer accessible online, said the online-only publication had 50,000 subscribers and nearly 1 million page views monthlywhich would have placed it in elite company in academic publishing.

Surgisphere appears over time to have shifted its efforts into developing a database of hospital records that could be used for research. When the pandemic erupted, Desai declared that his data set could answer key questions about the efficacy and safety of treatments. Speaking about the finding that hydroxychloroquine increases mortality in COVID-19 patients, the main finding from the now retracted Lancet paper, he told a Turkish TV reporter, with data like this, do we even need a randomized controlled trial? Soon after, the World Health Organization temporarily suspended enrolling patients for its COVID-19 trial of the drug.

Immediately after the Lancet and NEJM studies appeared, however, critics identified anomalies in the data. And they doubted that a tiny firmwith a scant public track record in AI, few employees, and no publicly named scientific boardcould convince hundreds of unidentified hospitals in dozens of nations to share complex, protected, and legally fraught patient data. Ultimately, despite Desai promising repeatedly to allow an independent audit of Surgisphere, the firm refused to release the raw patient data and agreements with hospitals for an audit, so no one could validate the authenticity of its database.

No hospitals have come forward to acknowledge working with Surgisphere. Indeed, NHS Scotland, which is mentioned as a case study on the companys website, says none of its hospitals worked with Surgisphere and that it would ask the firm to remove an image of a Glasgow hospital from its website.

Science contacted several of Desais current or former employees or colleagues. Most would not comment. But Fred Rahimi, an Illinois podiatrist and co-author of a paper with Desai, praises the surgeon as highly capable for salvaging limbs, and easy to work with. Through his publicist, Desai cited Mark Melin, a University of Minnesota, Twin Cities, vascular surgeon, as a supporter. Before the retractions, Melin called Desai a gentleman of the highest integrity who has nothing to cover up.

But one physician-scientist who worked closely with Desai several years ago, says, Just about everyone who knew him would say: I just didnt have a good feeling about him. After theyd been with him, most people dissociated themselves from him, the scientist says, declining to be named to avoid personal and institutional embarrassment.

In the decade since completing his medical residency, Desai moved from job to jobat Duke, the University of Texas, Southern Illinois University, and two private Illinois hospitals, according to his LinkedIn profile. You might say we should have stopped him, which now seems obvious, Desais former colleague says. We should have found a way to get together and say, Whats going on here? rather than allowing him to move from place to place. We should have done better as a medical community. We looked the other way.

Before and after his stint at the University of Miami, which appears to have started in late 2016 or early 2017, Patels academic home was the University of Utah. He started as a full-time faculty member at Utah in 2008 and kept that position until he left for Miami. The website for Foldax, a heart valve company that he serves as medical adviser, describes him as a Tenured Professor of Surgery in the Division of Cardiothoracic Surgery at the University of Utah School of Medicine and Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah.

The university confirmed Patel had tenure there, but says the directorship was an unofficial title. And among more than 100 publications listed on his University of Utah profile, nearly two-thirds were actually co-authored by other scientists who share the same surname. The page was removed from the university website after inquiries from Science.

According to the NIH database, Patel has never received funding from the agency. Before the recent COVID-19 papers, one of his most notable publications was a 2016 paper in The Lancet, which reported that extracting stem cells from the bone marrow of a person with end-stage heart failure and then reinjecting them could reduce the number of cardiac events that produced deaths or hospital admissions by 37%. The 126 patient, 31-site, phase II trial was billed in a press release, now not available on the University of Utah website but stored elsewhere, as the largest cell therapy trial for heart failure to date. Despite the apparent positive results, the sponsoring company Vericel no longer is developing stem cells for heart disease and, according to its webpage, is focused on advanced cell therapies for the sports medicine and severe burn care markets.

Patel left Miami under unclear circumstances, but has retained ties with Camillo Ricordi, an influential stem cell researcher at the University of Miami School of Medicine who is also the founder of a nonprofit called the Cure Alliance. The alliance previously focused on testing whether stem cells derived from umbilical cord blood could treat diabetes or Alzheimers, but has now pivoted to fighting COVID-19, according to its website. Ricordi is the principal investigator on a multisite trial to see whether the stem cells can treat lung inflammation in severe COVID-19 patients and Patel is listed in various references to the trial as a key contributor or coprincipal investigator. Ricordi did not reply to requests for comments on his relationship with Patel.

Patel recently tweeted that he is related to Dr. Desai by marriage but called that old news and added, Despite this I still do not have the information of what happened at Surgisphere. In addition to apparently connecting Mehra and Desai, Patel had prior connections with other authors of the NEJM paper and the preprint. David Grainger, co-author of the preprint, is a professor of biomedical engineering at the University of Utah and also works with Foldax. Grainger declined to comment.

Timothy Henry, a cardiovascular clinician and scientist at the Christ Hospital in Cincinnati and a co-author on the NEJM article, has written several scholarly articles with Patel, including the 2016 Lancet paper. Henry, who also declined to comment, advises Patels Triple-Gene, which develops cardiovascular gene therapy treatments. Henry and Patel adviseand Patel is a board member ofCreative Medical Technology Holdings, a Phoenix company that develops and markets stem cell therapies, including treatments purported to reverse aging and cure sexual disfunction.

Creative Medicals CaverStem and FemCelz kits are distributed to physicians who use them to extract stem cells from a patients bone marrow, then inject the cells into the penis or clitoral area to stimulate blood flow, according to a statement filed with the U.S. Securities and Exchange Commission. (As of the market close Friday, the publicly traded firms shares were valued at one-third of 1 cent.) The CaverStem treatments are advertised by the company as successful in more than 80% of patients, based on a 40-person phase I clinical trial that was not randomized or controlled, and on observations of 100 other patients. Phase I trials typically measure safety, not health benefits of a potential treatment.

Science contacted multiple colleagues or co-authors of Patel. None would comment. Before the retractions, two high-profile researchersDeepak Bhatt, who directs interventional cardiovascular programs at BWH; and Peter Gruber, a pediatric cardiothoracic surgeon at Yale Universityendorsed Patel on his LinkedIn page. Bhatt says he doesnt know Patel and attempted to remove his endorsement after being contacted by Science. Gruber says he overlapped with Patel at the University of Utah about a decade ago, but doesnt know his work in detail.

In contrast, Mehraauthor of more than 200 scholarly articles, editor of The Journal of Heart and Lung Transplantation, and head of the cardiology division of theUniversity of Maryland before moving to BWH in 2012enjoys considerable support even after the unraveling of the recent studies. Obviously, you dont rise to the position hes risen to without being ambitious, but Ive never had any indication whatsoever that he would do anything unethical, says Keith Aaronson, a cardiologist at the University of Michigan, Ann Arbor, who collaborated with Mehra on several studies, including a clinical trial of a mechanical pump for heart failure patients.

Mehra, the first author on both retracted papers, was the only one to issue a personal statement of apology, for failing to ensure that the data source was appropriate for this use. BWH and Harvard declined to say whether further investigation of Mehras roles in the papers would occur. (Mehra has written papers recently with another co-author of the Lancet paper, Frank Ruschitzka of University Hospital Zrich.)

I think he just fell into thisperhaps a little navely, says another former collaborator, cardiothoracic surgeon Daniel Goldstein of the Albert Einstein College of Medicine. Given the amount of data that was in the [Surgisphere] database, its just hard to believe someone would [fabricate] something like this.

Kassirer offers a harsher view: If youre a scientist and youre going to sign on to a project, by God you should know what the data are.

With reporting by Kelly Servick and John Travis.

This story was supported by theScienceFund for Investigative Reporting.

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June 9th, 2020

3D Cardiac Mapping Systems Market Segmentation Analysis and Global Industry Trends Forecast 2028 – Cole of Duty

By daniellenierenberg

Global 3D Cardiac Mapping Systems Market: Overview

Cardiac mapping is a special type of technique which helps in gathering and displaying the information from cardiac electrograms. Such technique is mainly used in the diagnosis of heart rhythms. Therefore, cardiac mapping technique has gained immense popularity in case of arrhythmia. The cardiac mapping procedure involves the percutaneous insertion of catheter into the heart chamber and recording the cardiac electrograms sequentially. Such procedure helps in correlating the cardiac anatomy with the electrograms. The latest 3D cardiac mapping systems provide the three dimensional model of hearts chamber, which further helps in tracking the exact location of the catheter. Such advantages are majorly driving the global 3D cardiac mapping systems market.

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From the perspective of technology, the global 3D cardiac mapping systems market is segmented into basket catheter mapping, electroanatomical mapping, and real-time positional management (Cardiac pathways) EP system. Among these segments, electroanatomical mapping segment accounts for the maximum share in the global 3D cardiac mapping systems market. This mapping are extensively used in several healthcare industry due to its potential in increasing the safety, accuracy, and efficiency of catheter. A research report by TMR Research (TMR) thoroughly explains the new growth opportunities in the global 3D cardiac mapping systems market. Additionally, the report also provides a comprehensive analysis of the markets competitive landscape.

Global 3D Cardiac Mapping Systems Market: Notable Developments

Some of the recent developments are contouring the shape of the global 3D cardiac mapping systems market in a big way:

Key players operating in the global 3D cardiac mapping systems market include BioScience Webster, Boston Scientific Corporation, and Abbott.

Global 3D Cardiac Mapping Systems Market: Key Growth Drivers

Rising Number of Patients with Cardiac Disorders and Arrhythmia Fillips Market

The global 3D cardiac mapping systems market has grown steadily over the years, owing to the convenience it provides to the patients with heart problem. Growing number of people with cardiovascular diseases and rising cases of arrhythmia are the major factors fueling growth in the global 3D cardiac mapping systems market. Along with this, increasing pressure for reducing diagnosis errors and rapidly rising healthcare expenditure are also responsible for boosting the global 3D cardiac mapping systems market. However, above all such factors, the global 3D cardiac mapping systems market is majorly fueled by the accuracy and patient safety provided through real-time monitoring. Such 3D cardiac mapping systems are mainly designed to improve the resolution. This system also helps in gaining prompt of cardiac activation maps. All such advantages are also providing impetus to the growth of the global 3D cardiac mapping systems market.

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Furthermore, rising ageing population who are prone to heart-attack and several chronic heart disorders and increasing diagnosis rate of cardiac illness are the factors stoking demand in the global 3D cardiac mapping systems market. Moreover, this 3D cardiac mapping helps in reducing the diagnosis time. Such factor is also contributing to the growth of the global 3D cardiac mapping systems market.

Global 3D Cardiac Mapping Systems Market: Regional Outlook

On the regional front, North America is leading the global 3D cardiac mapping systems market as the region has seen rapid growth in healthcare industry. Along with this, increasing prevalence of heart attacks, rising healthcare expenditure, and burgeoning population is also responsible for fueling growth in the 3D cardiac mapping systems market in this region.

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3D Cardiac Mapping Systems Market Segmentation Analysis and Global Industry Trends Forecast 2028 - Cole of Duty

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June 5th, 2020

CSL Behring and Seattle Children’s Research Institute to Advance Gene Therapy Treatments for Primary Immunodeficiency Diseases | DNA RNA and Cells |…

By daniellenierenberg

DetailsCategory: DNA RNA and CellsPublished on Wednesday, 03 June 2020 09:39Hits: 306

Initially, the alliance will develop treatment options for patients with two rare, life-threatening primary immunodeficiency diseases -- Wiskott-Aldrich Syndrome (WAS) and X-linked Agammaglobulinemia (XLA)

SEATTLE, WA and KING of PRUSSIA, PA, USA I June 2, 2020 I Seattle Children's Research Institute, one of the top pediatric research institutions in the world, and global biotechnology leader CSL Behring announced a strategic alliance to develop stem cell gene therapies for primary immunodeficiency diseases.

Initially, the alliance will focus on the development of treatment options for patients with two rare, life-threatening primary immunodeficiency diseases -- Wiskott-Aldrich Syndrome and X-linked Agammaglobulinemia. These are two of more than 400 identified primary immunodeficiency diseases in which a part of the body's immune system is missing or functions improperly.

"CSL Behring will collaborate with Seattle Children's experts to apply our novel gene therapy technology to their research pipeline, with an aim to address unmet needs for people living with certain rare primary immunodeficiency diseases," said Bill Mezzanotte, MD, Executive Vice President, Head of Research and Development for CSL Behring. "Expanding our gene therapy portfolio into an area of immunology well known to CSL exemplifies how we are strategically growing our capabilities in this strategic scientific platform and are collaborating with world class institutions to access innovation with the potential to vastly improve patients' lives."

"Stem cell gene therapies that correct the genetic abnormality driving a child's disease will transform the therapeutic options for children with Wiskott-Aldrich Syndrome, X-Linked Agammaglobulinemia and other immunodeficiency diseases,"said David J. Rawlings, MD, director of the Center for Immunity and Immunotherapies and division chief of immunology at Seattle Children's, and a professor of pediatrics and immunology at the University of Washington School of Medicine."The collaboration with CSL Behring supports our longstanding research programs for pediatric immunodeficiency diseases and will accelerate this research toward clinical trials, helping get these innovations to the children who need them."

CSL Behring researchers, working with researchers from Seattle Children's Research Institute, will investigate applying the proprietary platform technologies, Select+ and Cytegrity, to several pre-clinical gene therapy programs. These technologies, which have broad applications in ex vivo stem cell gene therapy, are designed to address some of the major challenges associated with the commercialization of stem cell therapy, including the ability to manufacture consistent, high-quality products, and to improve engraftment, efficacy and tolerability.

Wiskott-Aldrich Syndrome (WAS) has an estimated incidence between one and 10 cases per million males worldwide, according to the National Institutes of Health. WAS patients' immune systems function abnormally, making them susceptible to infections. They also experience eczema, autoimmunity and difficulty forming blood clots, leaving them vulnerable to life threatening bleeding complications. Today the only knowncurefor WAS is a stem cell transplant, if a suitable donor can be found.

X-linked Agammaglobulinemia (XLA) is another rare primary immunodeficiency in which patients have low levels of immunoglobulins (also known as antibodies), which are key proteins made by the immune system to help fight infections. Like WAS, XLA affects males almost exclusively, although females can be genetic carriers of the condition. While no cure exists for XLA, the goal of treatment is to boost the immune system by replacing missing antibodies and preventing or aggressively treating infections that occur, according to the Immune Deficiency Foundation.

About Seattle Children's

Seattle Children's mission is to provide hope, care and cures to help every child live the healthiest and most fulfilling life possible. Together, Seattle Children's Hospital, Research Institute and Foundation deliver superior patient care, identify new discoveries and treatments through pediatric research, and raise funds to create better futures for patients.

Ranked as one of the top children's hospitals in the country by U.S. News & World Report, Seattle Children's serves as the pediatric and adolescent academic medical center for Washington, Alaska, Montana and Idaho the largest region of any children's hospital in the country. As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is internationally recognized for its work in neurosciences, immunology, cancer, infectious disease, injury prevention and much more. Seattle Children's Hospital and Research Foundation works with the Seattle Children's Guild Association, the largest all-volunteer fundraising network for any hospital in the country, to gather community support and raise funds for uncompensated care and research. Join Seattle Children's bold initiative It Starts With Yes: The Campaign for Seattle Children's to transform children's health for generations to come.

For more information, visit seattlechildrens.org or follow us on Twitter, Facebook, Instagram or on our On the Pulse blog.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 70 countries. For more information, visit http://www.cslbehring.com and for inspiring stories about the promise of biotechnology, visit Vita http://www.cslbehring.com/Vita.

SOURCE: CSL Behring

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June 3rd, 2020

Hesperos demonstrates innovative Human-on-a-Chip approach to modeling innate immune system response following tissue damage and acute inflammation -…

By daniellenierenberg

ORLANDO, Fla.--(BUSINESS WIRE)--Hesperos Inc., pioneers of the Human-on-a-Chip in vitro system, today announced the publication of a new peer-reviewed publication that describes how the companys technology can be used to investigate immune responses following treatment with biological therapeutics for multi-organ systemic diseases, including cancer, infectious diseases and inflammatory disorders. The study was part of a collaboration between Hesperos, Hoffman-La Roche Pharmaceuticals and the University of Central Florida. The manuscript, titled Differential Monocyte Actuation in a Three-Organ Functional Innate Immune System-on-a-Chip, was published today in the prestigious journal Advanced Science. Click here to view a multimedia version of the press release, including media-ready images, downloadable resources, and more.

The immune system plays an important role in coordinating with other organ systems to combat infection, eliminate damaged cells and repair tissue. However, modeling immune response following drug treatment in preclinical studies is challenging due to poor predictability, especially for the innate portion of the system. As the scientific community begins to turn more towards using multi-organ, human-on-a-chip systems as a cost-effective way to increase efficiency and lower toxicity, many of these models lack a systemic immune component.

Hesperos, in collaboration with Hoffmann-La Roche Pharmaceuticals, describe an in vitro, pumpless, three-organ system containing functional human cardiomyocytes, skeletal muscle and hepatocytes in a serum-free medium, along with recirculating human monocyte THP-1 immune cells. Monocytes are a vital immune system cells involved in wound healing, pathogen clearance and activation of the innate immune response, but are also responsible for the cytokine storm found in conditions such as sepsis.

One application where the immune-system-on-a-chip can be immediately useful is for uncovering how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) directly affects multi-organ systems by activating the cytokine storm from inflammatory macrophages and to support the rapid development of therapeutics. As the global pandemic of COVID-19 continues to grow, this system has the potential to quickly evaluate antiviral and repurposed drugs to help combat this devastating disease, said Michael L. Shuler, Ph.D., Chief Executive Officer of Hesperos.

In the study, the researchers evaluated two different innate immune responses: 1) targeted immune response following tissue-specific damage, which simulates indirect activation of THP-1 cells and, 2) pro-inflammatory immune response following direct activation of immune cells, mimicking acute inflammation and the cytokine storm. Though not reported in this study, Hesperos has also shown that peripheral blood mononuclear cells (PBMCs) and T-cells are sustainable in these multi-organs systems, which would allow some aspects of adaptive immunity to also be modeled.

In the targeted immune response experiments, the cardiotoxic compound amiodarone was used to selectively damage cardiac cells to evaluate how THP-1 immune cells affect the three-organ system. The presence of both amiodarone and THP-1 immune cells led to a more pronounced reduction in cardiac force, conduction velocity and beat frequency compared to amiodarone alone. THP-1 cells were also found to infiltrate the damaged cardiomyocytes and induce significantly increased cytokine IL-6 expression, indicating an M2 macrophage phenotype. No immune-activated damage was reported in the skeletal muscle or liver cells.

The most striking features of our immune-system-on-a-chip is that it emulates different immune reactions for direct tissue-damage and acute inflammation, as well as distinguishes between M1 vs. M2 macrophage phenotypes, said James Hickman, Ph.D., Chief Scientist at Hesperos and Professor at the University of Central Florida.

The study was initially funded by Roche Pharmaceuticals and completed under an NIH grant from National Center for Advancing Translational Sciences (NCATS) Small Business Innovation Research program, which supports studies to advance tissue chip technology toward commercialization.

Tissue chips are a promising technology for accelerating the preclinical timeline and getting treatments to patients more efficiently, said Danilo A. Tagle, Ph.D., associate director for special initiatives at NCATS. Finding improved ways to study immune responses has tremendous implications for drug discovery and the development of more effective personalized medicines in diseases that affect multiple organ systems.

In the pro-inflammatory response experiments, the three-organ system was exposed to lipopolysaccharide (LPS) and interferon gamma (IFN-) to stimulate acute inflammation/cytokine storm and provoke monocyte differentiation and activation. In the absence of THP-1 immune cells, LPS/IFN- treatment had no significant effect on function of the three-organ system. However, with the addition of THP-1 immune cells, LPS/IFN- treatment caused cellular damage to all three-organ components, including THP-1 cell infiltration in liver tissue, and led to significant alterations in cardiac force and beat frequency, as well as skeletal muscle force. Additionally, there was an upregulation of pro-inflammatory cytokines, including TNF-, IL-6 and IL-10, indicating an M1 macrophage phenotype, which is analogous to the cytokine storm found during certain reactions to biologic therapeutics and emulates what occurs during sepsis.

To read the full manuscript, please visit https://doi.org/10.1002/advs.202000323.

About Hesperos

Hesperos, Inc. is a leader in efforts to characterize an individuals biology with Human-on-a-Chip microfluidic systems. Founders Michael L. Shuler and James J. Hickman have been at the forefront of every major scientific discovery in this realm, from individual organ-on-a-chip constructs to fully functional, interconnected multi-organ systems. With a mission to revolutionize toxicology testing as well as efficacy evaluation for drug discovery, the company has created pumpless platforms with serum-free cellular mediums that allow multi-organ system communication and integrated computational PKPD modeling of live physiological responses utilizing functional readouts from neurons, cardiac, muscle, barrier tissues and neuromuscular junctions as well as responses from liver, pancreas and barrier tissues. Created from human stem cells, the fully human systems are the first in vitro solutions that accurately utilize these platforms to predict in vivo functions without the use of animal models, as featured in Science. More information is available at https://hesperosinc.com

Hesperos and Human-on-a-Chip are trademarks of Hesperos Inc. All other brands may be trademarks of their respective holders.

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Hesperos demonstrates innovative Human-on-a-Chip approach to modeling innate immune system response following tissue damage and acute inflammation -...

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June 2nd, 2020

Canine Stem Cell Therapy Market Will Make a Huge Impact in Near Future – Cole of Duty

By daniellenierenberg

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

Parent Indicators Healthcare Current expenditure on health, % of gross domestic product Current expenditure on health, per capita, US$ purchasing power parities (current prices, current PPPs) Annual growth rate of current expenditure on health, per capita, in real terms Out-of-pocket expenditure, % of current expenditure on health Out-of-pocket expenditure, per capita, US$ purchasing power parity (current prices, current PPPs) Physicians, Density per 1000 population (head counts) Nurses, Density per 1000 population (head counts) Total hospital beds, per 1000 population Curative (acute) care beds, per 1000 population Medical technology, Magnetic Resonance Imaging units, total, per million population Medical technology, Computed Tomography scanners, total, per million population

Research Methodology

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Standard Report Structure Executive Summary Market Definition Macro-economic analysis Parent Market Analysis Market Overview Forecast Factors Segmental Analysis and Forecast Regional Analysis Competition Analysis

Target Audience Production Companies Suppliers Channel Partners Marketing Authorities Subject Matter Experts Research Institutions Financial Institutions Market Consultants Government Authorities

Market Taxonomy

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

Product Type: Allogeneic Stem Cells Autologous Stem cells

Application: Arthritis Dysplasia Tendonitis Lameness Others

End User: Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

Region: North America Latin America Europe Asia Pacific Japan Middle East & Africa

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Canine Stem Cell Therapy Market Will Make a Huge Impact in Near Future - Cole of Duty

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June 2nd, 2020

Photoaged Skin Therapy with Adipose-Derived Stem Cells – MedicalResearch.com

By daniellenierenberg

MedicalResearch.com Interview with:

Charles-de-SM.D., Ph.D.Rio de Janeiro, Brazil

MedicalResearch.com: What is the background for this study?

Response: Our clinical trial was based on our clinical skin observations in areas submitted to a lipotransfer previously, an ordinary practice in plastic surgery. These clinical observations lead us to investigate what will be the key element played in these findings. Our scientific support investigation addressed the Dardick1and Zuk, P2 studies, that demonstrated fibroblastic-like cells in adipose tissue with regenerative ability. Our clinical trial proposal is to investigate the adipose-derived stem cell (ADSC) role in the photoaged skin. The direct endpoint of the study was to assess the histological benefits provided by the subdermal ADSC injection. Mesenchymal stem cells were obtained from lipoaspirates, expanded in vitro, and introduced into the facial skin of 20 patients submitted after three to four months to a face-lifting surgery. In the retrieved skin, immunocytochemical and ultrastructural analysis quantified elastic matrix components, cathepsin-K, metalloprotease MMP-12, and the macrophage M2 markers: CD68, CD206 and heme-oxygenase-1.An overview of the trial steps is described in the infographic.

MedicalResearch.com: What are the main findings?

Response:A full de novo formation of oxytalan and elaunin fibers was observed in the subepidermal region, with a reconstitution of the papillary structure of the dermal-epidermal junction. Elastotic deposits in the deep dermis were substituted by a normal elastin fiber network. The coordinated removal of the pathologic deposits of old elastic fibers and their substitution by the normal ones was concomitant with activation of cathepsin-K and MPP12, and with expansion of the M2 macrophage infiltration.

MedicalResearch.com: What should readers take away from your report?

Response: This study has demonstrated ADSC to remodeling the skin extra cellular matrix, mainly in the elastic system.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Based on these findings, the future of thisresearch line aims to create new possibilities in regenerative cell therapy not only in skin diseases, but also in other clinical applicability in the case of organs and tissues with reduction and / or alteration in the elastic system (ex: aneurysms, cardiac valve disease and others), with a better understanding of the mechanisms involved and the control of these processes.

MedicalResearch.com: Is there anything else you would like to add? Any disclosures?

Response: It is interesting to be able, in future studies, to evaluate other mechanisms involved and the duration of effects regenerative effects on skin treated with ADSC. Another question could be considered: optimized ADSC (quantity) / area with the tissue effect found. We have not any to disclosure. This study was developed by federal university of Rio de Janeiro-Brasil and Verona University-Italy

Citation:

Charles-de-S, Luiz M.D., Ph.D.; Gontijo-de-Amorim, Natale Ferreira M.D., Ph.D.; Rigotti, Gino M.D., Ph.D.; Sbarbati, Andrea M.D., Ph.D.; Bernardi, Paolo Ph.D.; Benati, Donatella Ph.D.; Bizon Vieira Carias, Rosana Ph.D.; Maeda Takiya, Christina M.D., Ph.D.; Borojevic, Radovan Ph.D. Photoaged Skin Therapy with Adipose-Derived Stem Cells, Plastic and Reconstructive Surgery: June 2020 Volume 145 Issue 6 p 1037e-1049e doi: 10.1097/PRS.0000000000006867

References:

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

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Photoaged Skin Therapy with Adipose-Derived Stem Cells - MedicalResearch.com

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