Category Archives: Induced Pluripotent Stem Cells


Proof that the coronavirus can infect lab-grown brain cells might make its effects felt long-term – Health24

Compiled by Gabi Zietsman | Health24

08 Jul 2020, 04:45

How easily can the coronavirus infect the nervous system?

This is a question that could help us find better treatment - and prevent neurological damage that might incur in developing brains.

In Wuhan, 36% of Covid-19 patients showed signs of neurological symptoms, including viral inflammation of the brain. Researchers from Johns Hopkins University wanted to understand these symptoms better, and published their findings inALTEX: Alternatives to Animal Experimentation.

The virus's most popular gateway - ACE2 receptors - are found in certain neurons in the human body, which could make it susceptible to direct infection. Other types of coronaviruses are known to have a neuropathological effect on humans, but until know this hasn't been officially proven with the SARS-CoV-2 strain yet.

The researchers ended up testing their theories on lab-grown mini-brains to see if the virus can attack neural tissue directly.

The virus managed to replicate itself in the mini-brain in 72 hours.

"Virus particles were found in the neuronal cell body extending into apparent neurite structures." This means that the virus is able to invade neural tissue, giving it neurotropic features.

READ: Lab-grown mini-organs reveal the damage inflicted by Covid-19

Protection from the blood-brain-barrier

But the virus doesn't attack the neural system in all positive cases - the blood-brain-barrier normally prevents viral entry, but this can be impaired when the body's immunity is in distress.

This finding could also perhaps explain why the virus seems to cause a loss of taste and smell - a system controlled by our neural networks.

In the limited study time, however, the researchers saw no damage done to the mini-brain - just viral replication - but the lab-grown organ had no immune cells found in real human brains, thus neurological damage might still be possible.

"These experiments require repetition, including varied initial number of virus (MOI), analysis of neural pathology and functionality, inclusion of different donors of induced pluripotent stem cells of different genders, and extended time courses," adds the authors.

ALSO READ: How Covid-19 can affect your brain in 3 stages

What it means for our children

The mini-brain is also a developing organ - much like a child's - and there might be neurological disorders brewing in infected babies and children because their blood-brain-barrier isn't fully developed yet. This could also mark a risk for babies still in the womb if their mother becomes infected.

"Clinical evidence cannot yet be expected, however, as most children at critical phases of embryo and fetal development are yet to be born and more subtle neurodevelopmental disorders often take time to manifest and diagnose after birth.

"It will be important to study whether brain infection occurs also in otherwise asymptomatic patients, especially children with possible long-term consequences."

READ: Headache, dizziness before fever may signal Covid-19 and affect entire nervous system

Rise of organoids

Organoids - as these lab-grown organs are known - have increasingly become a vital method in fast-tracking Covid-19 understanding and possible treatment, especially as it lessens the need for animal testing.

Another recent study used lab-grown heart cells to also show how the coronavirus can infect one of our most vital organs - causing it to slowly stop beating.

It's critical for scientists to better understand how this coronavrius attacks the various functions of the body in order to advise more effective treatment - and watch out for yet unknown consequences lurking in the future.

SEE: Brain scan of 25-year-old Covid-19 patient who suffered mild symptoms

Image credit: iStock

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Proof that the coronavirus can infect lab-grown brain cells might make its effects felt long-term - Health24

Cell Culture Protein Surface Coating Market Global Sales, Revenue, Price and Gross Margin Forecast To 2025 – Owned

UpMarketResearch offers a latest published report on Global Cell Culture Protein Surface Coating Market industry analysis and forecast 20192025 delivering key insights and providing a competitive advantage to clients through a detailed report. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. The report contains XX pages which highly exhibits on current market analysis scenario, upcoming as well as future opportunities, revenue growth, pricing and profitability.

Cell Culture Protein Surface Coating Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report. The report contains basic, secondary and advanced information pertaining to the Cell Culture Protein Surface Coating global status and trend, market size, share, growth, trends analysis, segment and forecasts from 20192025.

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Global Cell Culture Protein Surface Coating Market, by Applications Monoclonal Antibody Protein Therapeutics Induced Pluripotent Stem Cells Research Cryobanking Cell-Based Assays Development Others

The Major Players Reported in the Market Include: Corning EMD Millipore Thermo Fisher Scientific Sigma-Aldrich

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Cell Culture Protein Surface Coating Market Global Sales, Revenue, Price and Gross Margin Forecast To 2025 - Owned

Induced Pluripotent Stem Cells (iPSCs) Market Growth By Manufacturers, Type And Application, Forecast To 2026 – 3rd Watch News

Regenerative Medicine

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The Induced Pluripotent Stem Cells (iPSCs) market report provides successfully marked contemplated policy changes, favorable circumstances, industry news, developments, and trends. This information can help readers fortify their market position. It packs various parts of information gathered from secondary sources, including press releases, web, magazines, and journals as numbers, tables, pie-charts, and graphs. The information is verified and validated through primary interviews and questionnaires. The data on growth and trends focuses on new technologies, market capacities, raw materials, CAPEX cycle, and the dynamic structure of the Induced Pluripotent Stem Cells (iPSCs) market.

This study analyzes the growth of Induced Pluripotent Stem Cells (iPSCs) based on the present, past and futuristic data and will render complete information about the Induced Pluripotent Stem Cells (iPSCs) industry to the market-leading industry players that will guide the direction of the Induced Pluripotent Stem Cells (iPSCs) market through the forecast period. All of these players are analyzed in detail so as to get details concerning their recent announcements and partnerships, product/services, and investment strategies, among others.

Sales Forecast:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Induced Pluripotent Stem Cells (iPSCs) market. Additionally, it includes a share of each segment of the Induced Pluripotent Stem Cells (iPSCs) market, giving methodical information about types and applications of the market.

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In the end, the Induced Pluripotent Stem Cells (iPSCs) market is analyzed for revenue, sales, price, and gross margin. These points are examined for companies, types, applications, and regions.

To summarize, the global Induced Pluripotent Stem Cells (iPSCs) market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Induced Pluripotent Stem Cells (iPSCs) Market Growth By Manufacturers, Type And Application, Forecast To 2026 - 3rd Watch News

In Vitro Toxicology Testing Market to Exhibit Rapid Surge in Consumption in the COVID-19 Crisis 2024 – 3rd Watch News

[112 Report Pages] This market research report identifies Laboratory Corporation of America Holdings, Charles River Laboratories, Inc, Thermo Fisher Scientific, Eurofins Scientific, Agilent Technologies, Inc., as the major vendors operating in the global in vitro toxicology testing market. This report also provides a detailed analysis of the market by toxicology end points (systemic toxicity, cytotoxicity testing, genotoxicity testing, ocular toxicity, organ toxicity, dermal toxicity, neurotoxicity, and others), industry type (pharmaceutical and biopharmaceutical, cosmetics, chemical, diagnostics, and food industry), and region (North America, Europe, Asia Pacific, and Rest of the World).

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Infoholicsmarket research report predicts that theglobalin vitro toxicology testingmarketwill grow at a CAGR of8.2%during the forecast period 20182024.The market for in vitro toxicology testing is driven by high opposition to animal testing, increased cost related to animal-based toxicity testing, and increasing R&D expenditure for early stage toxicity testing. Whereas, the lack of in vitro models and decreased adoption rate are limiting the growth of the in vitro toxicology testingmarket to an extent.

According to the in vitro toxicology testingmarket analysis, Europe accounted for the largest share of the global in vitro toxicology testingmarket followed by North America in 2017. The reason is the upsurge in the investments by the European Commission in R&D to develop substitute methods to in vitro testing is driving the demand in this region. Asia Pacific is expected to grow at a high CAGR during the forecast period due to increasing number of contract research organizations offering testing services, advancements in healthcare infrastructure, increasing investments in the biopharmaceutical sector, and upward economic conditions in the region.

Competitive Analysis and Key Vendors:

There is an increase in collaborations between companies on in vitro testing of compounds. For instance, in December 2016, Evotec and Celgene entered into a drug discovery collaboration for neurodegenerative diseases. According to agreement terms, Celgene will use Evotecs unique induced pluripotent stem cell (iPSC) platform that enables systematic drug screening in patient-derived disease models. In June 2017, Censo Biotechnologies Ltd. collaborated with Evotec AG to source and provide patient-derived induced pluripotent stem cells to support Evotecs drug discovery iPSC platform. In addition, the companies are also coming up with new products for in vitro testing. For instance, in January 2018, STEMCELL Technologies Inc. released two product lines for organoid research that will enable scientists to create powerful models for studying human disease in the laboratory.

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Some of the In Vitro Toxicology Testing Market key vendorsare:

Other prominent vendors in the global in vitro toxicology testing market are Bio-Rad Laboratories, GE Healthcare, SGS SA, BioIVT, Abbott Laboratories, Gentronix Limited, Promega Corporation, MB Research Laboratories, Evotec AG (Cyprotex plc), Catalent, Inc., Qiagen N.V., and niche players.

In Vitro Toxicology Testing Market by Toxicology End Points:

In 2017, the systemic toxicity accounted for the highest market share due to the availability of a wide range of sub-studies, which ensure total analysis of toxicity and safety margin of the testing compounds.

In Vitro Toxicology Testing Market by Industry type:

In 2017, the pharmaceutical and biopharmaceutical industry occupied significant market share and the cosmetics industry is expected to hold a high percentage during the forecast period. Increased support of regulatory authorities to use in vitro and in silico methods instead of animal testing to check toxicology is driving the growth of the cosmetic industry.

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The report provides detailed information about the services offered by in vitro toxicology testingin various therapeutic verticals and regions. With that, key stakeholders can find out the major trends, drivers, investments, and vertical players initiatives. Moreover, the report provides details about the major challenges that are going to have an impact on market growth. Additionally, the report gives complete details about the business opportunities to key stakeholders to expand their business and capture revenues in the specific verticals. The report will help companies interested or established in this market to analyze the various aspects of this domain before investing or expanding their business in the in vitro toxicology testingmarket.

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Global Stem Cells Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By MRE – Cole of Duty

This report will definitely help you make well informed decisions related to the stem cell market. The stem cell therapy market includes large number of players that are involved in development of stem cell therapies of the treatment of various diseases. Mesoblast Ltd. (Australia), Aastrom Biosciences, Inc. (U.S.), Celgene Corporation (U.S.), and StemCells, Inc. (U.S.) are the key players involved in the development of stem cell therapies across the globe.

The global stem cells market is expected to grow at an incredible CAGR of 25.5% from 2018to 2024and reach a market value of US$ 586 billion by 2025. The emergence of Induced Pluripotent Stem (iPS) cells as an alternative to ESCs (embryonic stem cells), growth of developing markets, and evolution of new stem cell therapies represent promising growth opportunities for leading players in this sector.

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Due to the increased funding from Government and Private sector and rising global awareness about stem cell therapies and research are the main factors which are driving this market. A surge in therapeutic research activities funded by governments across the world has immensely propelled the global stem cells market. However, the high cost of stem cell treatment and stringent government regulations against the harvesting of stem cells are expected to restrain the growth of the global stem cells market.

The stem cell therapy market includes large number of players that are involved in development of stem cell therapies of the treatment of various diseases. Mesoblast Ltd. (Australia), Aastrom Biosciences, Inc. (U.S.), Celgene Corporation (U.S.), and StemCells, Inc. (U.S.) are the key players involved in the development of stem cell therapies across the globe.

This market research report categorizes the stem cell therapy market into the following segments and sub-segments:

The Global Stem Cell Market this market is segmented on the basis of Mode of Therapy, Therapeutic Applications and Geography.

By Mode of Therapy this market is segmented on the basis of Allogeneic Stem Cell Therapy Market and Autologous Stem Cell Therapy Market. Allogeneic Stem Cell Therapy Market this market is segmented on the basis of CVS Diseases, CNS Diseases, GIT diseases, Eye Diseases, Musculoskeletal Disorders, Metabolic Diseases, Immune System Diseases, Wounds and Injuries and Others. Autologous Stem Cell Therapy Market this market is segmented on the basis of GIT Diseases, Musculoskeletal Disorders, CVS Diseases, CNS Diseases, Wounds and Injuries and Others. By Therapeutic Applications this market is segmented on the basis of Musculoskeletal Disorders, Metabolic Diseases, Immune System Diseases, GIT Diseases, Eye Diseases, CVS Diseases, CNS Diseases, Wounds and Injuries and Others.

By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

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Table of Contents

1 INTRODUCTION

2 Research Methodology

2.1 Research Data 2.1.1 Secondary Data 2.1.1.1 Key Data From Secondary Sources 2.1.2 Primary Data 2.1.2.1 Key Data From Primary Sources 2.1.2.2 Breakdown of Primaries 2.2 Market Size Estimation 2.2.1 Bottom-Up Approach 2.2.2 Top-Down Approach 2.3 Market Breakdown and Data Triangulation 2.4 Research Assumptions

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Industry Insights

7 Global Stem Cell Therapy Market, By Type

8 Global Stem Cell Therapy Market, By Therapeutic Application

9 Global Stem Cell Therapy Market, By Cell Source

10 Stem Cell Therapy Market, By Region

11 Competitive Landscape

12 Company Profiles

12.1 Introduction

12.1.1 Geographic Benchmarking

12.2 Osiris Therapeutics, Inc.

12.3 Medipost Co., Ltd.

12.4 Anterogen Co., Ltd.

12.5 Pharmicell Co., Ltd.

12.6 Holostem Terapie Avanzate Srl

12.7 JCR Pharmaceuticals Co., Ltd.

12.8 Nuvasive, Inc.

12.9 RTI Surgical, Inc.

12.10 Allosource

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2020-2024 Global Regenerative Medicine Market with Impact Analysis of COVID-19, Production, Revenue, Demand & Applications – Apsters News

Scope of the Report

The report titled Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024), provides an in-depth analysis of the global regenerative medicine market with description of market sizing and growth. The analysis includes market by value, by product, by material and by region. Furthermore, the report also provides detailed product analysis, material analysis and regional analysis.

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Moreover, the report also assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall global regenerative medicine market has also been forecasted for the years 2020-2024, taking into consideration the previous growth patterns, the growth drivers and the current and future trends.

Some of the major players operating in the global regenerative medicine market are Novartis AG, Medtronic Plc, Bristol Myers Squibb (Celgene Corporation) and Smith+Nephew (Osiris Therapeutics, Inc.), whose company profiling has been done in the report. Furthermore, in this segment of the report, business overview, financial overview and business strategies of the respective companies are also provided.

Region Coverage

North America Europe Asia Pacific ROW

Company Coverage

Novartis AG Medtronic Plc Bristol Myers Squibb (Celgene Corporation) Smith+Nephew (Osiris Therapeutics, Inc.)

Executive Summary

Regenerative medicines emphasis on regeneration or replacement of tissues, cells or organs of human body to cure the problem caused by disease or injury. The treatment fortify human cells to heal up or transplant stem cells into the body to regenerate lost tissues or organs or to recover impaired functionality. There are three types of stem cells that can be used in regenerative medicine: somatic stem cells, embryonic stem cells (ES cells) and induced pluripotent stem cells (iPS cells).

The regenerative medicine also has the capability to treat chronic diseases and conditions, including Alzheimers, diabetes, Parkinsons, heart disease, osteoporosis, renal failure, spinal cord injuries, etc. Regenerative medicines can be bifurcated into different product type i.e., cell therapy, tissue engineering, gene therapy and small molecules and biologics. In addition, on the basis of material regenerative medicine can be segmented into biologically derived material, synthetic material, genetically engineered materials and pharmaceuticals.

The global regenerative medicine market has surged at a progressive rate over the years and the market is further anticipated to augment during the forecasted years 2020 to 2024. The market would propel owing to numerous growth drivers like growth in geriatric population, rising global healthcare expenditure, increasing diabetic population, escalating number of cancer patients, rising prevalence of cardiovascular disease and surging obese population.

Though, the market faces some challenges which are hindering the growth of the market. Some of the major challenges faced by the industry are: legal obligation and high cost of treatment. Whereas, the market growth would be further supported by various market trends like three dimensional bioprinting , artificial intelligence to advance regenerative medicine, etc.

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Table of Contents

1. Executive Summary

2. Introduction

2.1 Regenerative Medicine: An Overview 2.2 Regeneration in Humans: An Overview 2.3 Expansion in Peripheral Industries of Regenerative Medicine 2.4 Approval System for Regenerative Medicine Products 2.5 Regenerative Medicine Segmentation

3. Global Market Analysis

3.1 Global Regenerative Medicine Market: An Analysis

3.1.1 Global Regenerative Medicine Market by Value 3.1.2 Global Regenerative Medicine Market by Products (Cell Therapy, Tissue Engineering, Gene Therapy and Small Molecules and Biologics) 3.1.3 Global Regenerative Medicine Market by Material (Biologically Derived Material, Synthetic Material, Genetically Engineered Materials and Pharmaceuticals) 3.1.4 Global Regenerative Medicine Market by Region (North America, Europe, Asia Pacific and ROW)

3.2 Global Regenerative Medicine Market: Product Analysis

3.2.1 Global Cell Therapy Regenerative Medicine Market by Value 3.2.2 Global Tissue Engineering Regenerative Medicine Market by Value 3.2.3 Global Gene Therapy Regenerative Medicine Market by Value 3.2.4 Global Small Molecules and Biologics Regenerative Medicine Market by Value

3.3 Global Regenerative Medicine Market: Material Analysis

3.3.1 Global Biologically Derived Material Market by Value 3.3.2 Global Synthetic Material Market by Value 3.3.3 Global Genetically Engineered Materials Market by Value 3.3.4 Global Regenerative Medicine Pharmaceuticals Market by Value

4. Regional Market Analysis

4.1 North America Regenerative Medicine Market: An Analysis 4.1.1 North America Regenerative Medicine Market by Value

4.2 Europe Regenerative Medicine Market: An Analysis 4.2.1 Europe Regenerative Medicine Market by Value

4.3 Asia Pacific Regenerative Medicine Market: An Analysis 4.3.1 Asia Pacific Regenerative Medicine Market by Value

4.4 ROW Regenerative Medicine Market: An Analysis 4.4.1 ROW Regenerative Medicine Market by Value

5. COVID-19

5.1 Impact of Covid-19 5.2 Response of Industry to Covid-19 5.3 Variation in Organic Traffic 5.4 Regional Impact of COVID-19

6. Market Dynamics

6.1 Growth Drivers 6.1.1 Growth in Geriatric Population 6.1.2 Rising Global Healthcare Expenditure 6.1.3 Increasing Diabetic Population 6.1.4 Escalating Number of Cancer Patients 6.1.5 Rising Prevalence of Cardiovascular Disease 6.1.6 Surging Obese Population

6.2 Challenges 6.2.1 Legal Obligation 6.2.2 High Cost of Treatment

6.3 Market Trends 6.3.1 3D Bio-Printing 6.3.2 Artificial Intelligence to Advance Regenerative Medicine

7. Competitive Landscape

7.1 Global Regenerative Medicine Market Players: A Financial Comparison 7.2 Global Regenerative Medicine Market Players by Research & Development Expenditure

8. Company Profiles

8.1 Bristol Myers Squibb (Celgene Corporation) 8.1.1 Business Overview 8.1.2 Financial Overview 8.1.3 Business Strategy

8.2 Medtronic Plc 8.2.1 Business Overview 8.2.2 Financial Overview 8.2.3 Business Strategy

8.3 Smith+Nephew (Osiris Therapeutics, Inc.) 8.3.1 Business Overview 8.3.2 Financial Overview 8.3.3 Business Strategy

8.4 Novartis AG 8.4.1 Business Overview 8.4.2 Financial Overview 8.4.3 Business Strategy

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2020-2024 Global Regenerative Medicine Market with Impact Analysis of COVID-19, Production, Revenue, Demand & Applications - Apsters News

Stem Cell Therapy Market Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2020 2025 – Owned

A report on Stem Cell Therapy market compiled by Brand Essence Market Research provides a succinct analysis regarding the values and trends existing in the current business scenario. The study also offers a brief summary of market valuation, market size, regional outlook and profit estimations of the industry. Furthermore, the report examines the competitive sphere and growth strategies of leading players in the Stem Cell Therapy market.

In 2018, the GlobalStem Cell Therapy Marketsize was xx million US$ and it is expected to reach xx million US$ by the end of 2025, with a CAGR of xx% during 2019-2025.

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Key playersof the Stem Cell Therapy market are Gilead, Novartis, Organogenesis, Vericel, Others

Stem Cell Therapy Market Segmentation:

Reports include the following segmentation: By Product TypeAdult Stem CellsHuman Embryonic Stem Cells (hESC)Induced Pluripotent Stem CellsVery Small Embryonic Like Stem CellsBy Applications TypeRegenerative MedicineDrug Discovery and DevelopmentBy TechnologyCell AcquisitionCell ProductionCryopreservationExpansion and Sub-CultureBy Cell TherapyAutologousAllogeneicBy RegionNorth Americao U.S.o Canadao MexicoEuropeo UKo Franceo Germanyo Russiao Rest of EuropeAsia-Pacifico Chinao South Koreao Indiao Japano Rest of Asia-PacificLAMEAo Latin Americao Middle Easto Africa

Region Coverage (Regional Production, Demand & Forecast by Countries etc.): North America (U.S., Canada, Mexico) Europe (Germany, U.K., France, Italy, Russia, Spain etc.) Asia-Pacific (China, India, Japan, Southeast Asia etc.) South America (Brazil, Argentina etc.) Middle East & Africa (Saudi Arabia, South Africa etc.)

Table of Contents

1 Report Overview 1.1 Study Scope 1.2 Key Market Segments 1.3 Players Covered 1.4 Market Analysis by Type 1.4.1 Global Stem Cell Therapy Market Size Growth Rate by Type (2014-2025) 1.4.2 Topical Products 1.4.3 Botulinum 1.4.4 Dermal Fillers 1.4.5 Chemical Peels 1.4.6 Microabrasion Equipment 1.4.7 Laser Surfacing Treatments 1.5 Market by Application 1.5.1 Global Stem Cell Therapy Market Share by Application (2014-2025) 1.5.2 Hospitals 1.5.3 Dermatology Clinics 1.6 Study Objectives 1.7 Years Considered

2 Global Growth Trends 2.1 Stem Cell Therapy Market Size 2.2 Stem Cell Therapy Growth Trends by Regions 2.2.1 Stem Cell Therapy Market Size by Regions (2014-2025) 2.2.2 Stem Cell Therapy Market Share by Regions (2014-2019) 2.3 Industry Trends 2.3.1 Market Top Trends 2.3.2 Market Drivers 2.3.3 Market Opportunities

3 Market Share by Key Players 3.1 Stem Cell Therapy Market Size by Manufacturers 3.1.1 Global Stem Cell Therapy Revenue by Manufacturers (2014-2019) 3.1.2 Global Stem Cell Therapy Revenue Market Share by Manufacturers (2014-2019) 3.1.3 Global Stem Cell Therapy Market Concentration Ratio (CR5 and HHI) 3.2 Stem Cell Therapy Key Players Head office and Area Served 3.3 Key Players Stem Cell Therapy Product/Solution/Service 3.4 Date of Enter into Stem Cell Therapy Market 3.5 Mergers & Acquisitions, Expansion Plans

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Stem Cell Therapy Market Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2020 2025 - Owned

Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute…

CRANFORD, N.J., June 26, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of acute respiratory distress syndrome (ARDS) in patients with COVID-19.

The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials. The Company plans to initiate actions on the FDA's recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the Coronavirus Treatment Acceleration Program (CTAP).

Myron Holubiak, Chief Executive Officer of Citius, commented, "We appreciate the FDA's thoughtful guidance on our unique, allogenic mesenchymal stem cells derived from induced pluripotent stem cells (iPSCs). We understand that iPSC-derived stem cells are not the same as adult-donor derived cells and, therefore, would require different proof of concept studies. Since we believe in the advantages of iPSC MSCs over donor-derived cells, we intend to develop assays recommended by the FDA and demonstrate the safety of these MSCs in our preclinical studies. We are committed to the successful completion of the required clinical trials to provide an effective and safe therapy for ARDS due to COVID-19."

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visitwww.citiuspharma.com.

About Citius iMSCCitius's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Coronavirus Treatment Acceleration Program (CTAP)In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 would benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement for a potential ARDS therapy with Novellus, Inc. within the option period; the ability to access the FDA's CTAP program for our planned ARDS therapy; risks associated with developing our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:

Andrew Scott Vice President, Corporate Development (O) 908-967-6677 x105 [emailprotected]

SOURCE Citius Pharmaceuticals, Inc.

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Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute...

Induced Pluripotent Stem Cells Market 2020 Global Industry …

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Jun 18, 2020 (The Expresswire) -- Induced Pluripotent Stem Cells Market 2020 Global Industry Trends, Size, Share Analysis Report. According to this report Global Induced Pluripotent Stem Cells Market will rise from Covid-19 crisis at moderate growth rate during 2020 to 2026. Induced Pluripotent Stem Cells Market includes comprehensive information derived from depth study on Induced Pluripotent Stem Cells Industry historical and forecast market data. Global Induced Pluripotent Stem Cells Market Size To Expand moderately as the new developments in Induced Pluripotent Stem Cells and Impact of COVID19 over the forecast period 2020 to 2026.

Induced Pluripotent Stem Cells Market report provides depth analysis of the market impact and new opportunities created by the COVID19/CORONA Virus pandemic. Report covers Induced Pluripotent Stem Cells Market report is helpful for strategists, marketers and senior management, And Key Players in Induced Pluripotent Stem Cells Industry.

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Global Induced Pluripotent Stem Cells Market Insights:

Report Analyzes Global Induced Pluripotent Stem Cells Market Growth Size, Share And Trends By Derived Cell Type (Amniotic cells, Fibroblasts, Keratinocytes, Hepatocytes, Others), By Application (Regenerative medicines, Drug development, Toxicity testing, Reprogramming technology, Academic research, Others), By End-user (Hospitals, Education and research institutes, Biotechnological companies) and Geography Forecast till 2026.

Key players are involved in mergers and acquisition to strengthen their market position. Owing to increasing competition frequent innovations are taking place in the market. Some of the companies operating the industry are: Astellas Pharma, Ncardia, Applied StemCell, FUJIFILM Cellular Dynamics, Axol Bioscience, Bristol-Myers Squibb Company, RandD Systems, Fate Therapeutics, Evotec AG, ViaCyte Inc.

STEMCELL Technologies Inc., a global biotechnology company launched mTeSR Plus, an enhanced version of mTeSR1, a widely published feeder-free human pluripotent stem cell (hPSC) maintenance medium. mTeSR Plus will be used to prevent onset acidosis. The launch of mTeSR Plus is likely to encourage global induced pluripotent stem cells growth owing to the design of the mTeSR Plus, which offers more consistent cell culture environment through sustained medium pH and stabilized components including FGF2. Furthermore, warning by FDA for marketing dangerous unapproved stem cells products is expected to alert pharmaceutical companies to market FDA approved products. This factor will, in turn, enable growth of the global induced pluripotent stem cells. For instance, the U.S Food and Drug Administration (FDA) sent a warning to Genetech, Inc. for marketing stem cell therapy without the U.S FDA approval and nonconformity of Good Manufacturing Practice (CGMP).

Active government support for RandD activities through research grants is driving the global induced pluripotent stem cells. Increasing private funding and rising shift towards regenerative medicines are predicted to favor induced pluripotent stem cells revenue. Further, induced pluripotent stem cells have created new avenues in clinical research, regenerative medicines, and disease modeling. This has also paved the way to numerous mergers and acquisitions and potential pipeline products and patents. In addition, the diversity of donor candidates is a factor predicted to aid induced pluripotent stem cells growth. Moreover, increasing accessibility towards the cell of origin is also expected to boost the global induced pluripotent stem cells market in the forthcoming year. However, ethical issues related to the donors and potential risk of tumors are factors predicted to hamper the growth of the global induced pluripotent stem cells.

Regional Market Overview:

Regional analysis is another highly comprehensive part of the research and analysis study of the global market presented in the report. This section sheds light on the sales growth of different regional and country-level markets. For the historical and forecast period to 2024, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global market.

Geographically, the global induced pluripotent stem cells market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. North America is expected to dominate the global induced pluripotent stem cells market during the forecast period due to the increasing RandD investment by key players for potential pipeline products. In Europe, the global induced pluripotent stem cells market is anticipated to grow significantly during the forecast period. The active government support and product launches are predicted to favor growth in the region. For instance, in 2018, Ncardia, a company working for drug discovery using stem cell, launched Xpress.4U LightPace Cor.4U, a kit for improving and simplifying the use of optical pacing of cardiomyocytes, a human induced pluripotent stem cell. The aforementioned factors together are enabling growth in Europe.

Intended Audience:

Competitive Analysis:

The Induced Pluripotent Stem Cells Market report examines competitive scenario by analyzing key players in the market. The company profiling of leading market players is included this report with Porter's five forces analysis and Value Chain analysis. Further, the strategies exercised by the companies for expansion of business through mergers, acquisitions, and other business development measures are discussed in the report. The financial parameters which are assessed include the sales, profits and the overall revenue generated by the key players of Market.

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Report Highlights:

In-depth information about the latest Induced Pluripotent Stem Cells Industry trends, opportunities, and challenges.

Extensive analysis of the growth drivers And barriers.

Competitive landscape consisting of investments, agreements, contracts, novel product launches, strategic collaborations, and mergers and acquisitions.

List of the segments and the niche areas.

Comprehensive details about the strategies that are being adopted by key players.

Table of Content:

1.1. Research Scope

1.2. Market Segmentation

1.3. Research Methodology

1.4. Definitions and Assumptions

3.1. Market Drivers

3.2. Market Restraints

3.3. Market Opportunities

4.1. Prevalence of Key Indications, 2017 (Key Countries)

4.2. Economic (Key Countries)

4.3. Key Mergers and Acquisitions

4.4. Pricing Analysis, Key Players, 2017

4.5. Overview: New Developments in Induced Pluripotent Stem Cells

5.1. Key Findings / Summary

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Induced Pluripotent Stem Cells Market 2020 Global Industry ...

Induced Pluripotent Stem Cells Market Analysis, Top Manufacturers, Share, Growth, Statistics, Opportunities and Forecast To 2026 – Cole of Duty

Reprocell

Induced Pluripotent Stem Cells Market Competitive Landscape & Company Profiles

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 Induced Pluripotent Stem Cells market.

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 Induced Pluripotent Stem Cells 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.

Induced Pluripotent Stem Cells Market, By Product

Regions Covered in these Report:

Asia Pacific (China, Japan, India, and Rest of Asia Pacific) Europe (Germany, the UK, France, and Rest of Europe) North America (the US, Mexico, and Canada) Latin America (Brazil and Rest of Latin America) Middle East & Africa (GCC Countries and Rest of Middle East & Africa)

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Induced Pluripotent Stem Cells Market Research Methodology

The research methodology adopted for the analysis of the market involves the consolidation of various research considerations such as subject matter expert advice, primary and secondary research. Primary research involves the extraction of information through various aspects such as numerous telephonic interviews, industry experts, questionnaires and in some cases face-to-face interactions. Primary interviews are usually carried out on a continuous basis with industry experts in order to acquire a topical understanding of the market as well as to be able to substantiate the existing analysis of the data.

Subject matter expertise involves the validation of the key research findings that were attained from primary and secondary research. The subject matter experts that are consulted have extensive experience in the market research industry and the specific requirements of the clients are reviewed by the experts to check for completion of the market study. Secondary research used for the Induced Pluripotent Stem Cells market report includes sources such as press releases, company annual reports, and research papers that are related to the industry. Other sources can include government websites, industry magazines and associations for gathering more meticulous data. These multiple channels of research help to find as well as substantiate research findings.

Table of Content

1 Introduction of Induced Pluripotent Stem Cells Market

1.1 Overview of the Market 1.2 Scope of Report 1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining 3.2 Validation 3.3 Primary Interviews 3.4 List of Data Sources

4 Induced Pluripotent Stem Cells Market Outlook

4.1 Overview 4.2 Market Dynamics 4.2.1 Drivers 4.2.2 Restraints 4.2.3 Opportunities 4.3 Porters Five Force Model 4.4 Value Chain Analysis

5 Induced Pluripotent Stem Cells Market, By Deployment Model

5.1 Overview

6 Induced Pluripotent Stem Cells Market, By Solution

6.1 Overview

7 Induced Pluripotent Stem Cells Market, By Vertical

7.1 Overview

8 Induced Pluripotent Stem Cells Market, By Geography

8.1 Overview 8.2 North America 8.2.1 U.S. 8.2.2 Canada 8.2.3 Mexico 8.3 Europe 8.3.1 Germany 8.3.2 U.K. 8.3.3 France 8.3.4 Rest of Europe 8.4 Asia Pacific 8.4.1 China 8.4.2 Japan 8.4.3 India 8.4.4 Rest of Asia Pacific 8.5 Rest of the World 8.5.1 Latin America 8.5.2 Middle East

9 Induced Pluripotent Stem Cells Market Competitive Landscape

9.1 Overview 9.2 Company Market Ranking 9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview 10.1.2 Financial Performance 10.1.3 Product Outlook 10.1.4 Key Developments

11 Appendix

11.1 Related Research

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