About Stem Cell Treatments – Institute for Stem Cell …

A Word of Caution on Stem Cell Clinics

We must caution the consumer to be wary of clinics that promise to deliver curative stem cell therapies, and to exercise extreme caution when considering enrollment in a clinical trial being offered by a stem cell clinic. It falls to the consumer to investigate whether the clinical trial is being conducted with FDA oversight, or whether a therapy accompanied by numerous testimonials has been scientifically proven safe, effective, and FDA-approved.

Fortunately, oversight of stem cell clinics is increasing. On Thursday, March 22, Governor Inslee signed into lawHouse Bill 2356. This legislation will require Washington State stem-cell clinics to post a visible notice that their injection procedures are not FDA-approved and that patients should consult with primary-care providers before undergoing one.

At this point in time only a few FDA-approved stem cell-based treatments are available. One such treatment is the use of blood stem cells and umbilical cord stem cells to treat and even cure individuals with blood cancers such as leukemia.

The methodology used by most of the stem cell clinics currently advertising available therapies is to remove adult stem cells from one part of a persons body, minimally process the cells, and then inject the cells into another part of their body. This use of adult stem cells has never been vigorously tested. It has never been demonstrated to be safe or even effective. These widely-advertised clinics are able to circumvent the FDA because they minimally manipulate the cells, a regulatory loophole that enables them to offer this treatment without regulatory oversight.

A highly publicized article in the New England Journal of Medicine reported cases of severe vision loss in patients with macular degeneration who had received injections of their own adipose stem cells into their eyes. *The injections were conducted by a Florida stem cell clinic under the auspices of a clinical trial that had not been reviewed by the FDA.

Take care of yourself!

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Former U.S. Secretary of Energy and Texas Governor, Rick Perry, Names Two Texas Companies as Leading Innovators in the Fight Against COVID-19 -…

HOUSTON--(BUSINESS WIRE)--Celltex Therapeutics Corporation, a Houston, Texas-based biotechnology company and a leader in Mesenchymal Stem Cell (MSC) banking and technology, recently announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Companys COVID-19 Phase II clinical trial evaluating Celltex-produced autologous (ones own) adipose tissue(fat)-derived Mesenchymal Stem Cells (AdMSCs) to provide immune support and prevent COVID-19. Medistar Corporation, a medical real estate company specializing in healthcare projects, and researchers in Texas have developed an air conditioning system that can catch and kill coronavirus 2 (SARS-CoV-2) in an effort to help both essential workers, schools and the general public combat the COVID-19 pandemic.

Former United States Secretary of Energy and Texas Governor, Rick Perry, recently listed both companies promising technologies during a national cable news broadcast when he discussed potential treatments to protect the public from the coronavirus. As a vaccine can take years to develop, Rick Perry has been paying close attention to treatments and therapies that are both effective and available and wants to ensure that the public is aware that there is hope on the horizon with new medical technology.

With the continued spread of COVID-19, Americans are looking for immediate hope and want to hear a message from leaders that there are opportunities and therapies that are not too far out into the future and that can fight this virus, said Mr. Perry. Celltex Therapeutics clinical trials to demonstrate Celltexs MSCs ability to be a powerful preventative against COVID-19, as well as a development from another company, Medistar Corporation, which worked with researchers to create a biodefense filter that goes into HVAC systems and kills 99.8% of the virus. These are incredible breakthroughs that could help curb the spread of COVID-19 in peoples bodies and their environments. Concerning Medistars biodefense filter in particular, it could represent an opportunity to enable our kids to return to school in September.

Celltexs Phase II multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and prophylactic efficacy of MSCs to prevent COVID-19 was approved to proceed by the FDA based on Celltexs long history of producing its own proprietary MSCs in its cGMP FDA-compliant lab for more than 9,000 therapies administered without any adverse reaction. Celltex is currently enrolling 200 subjects in the study who are classified as at higher risk for contracting COVID-19 (https://www.clinicaltrials.gov/ct2/show/NCT04428801) and who have not been infected. One hundred subjects will receive intravenous infusions of autologous MSCs produced by Celltex while 100 will receive placebo treatments. The primary efficacy endpoint of the study is to evaluate overall safety of Celltexs MSCs. The secondary objective is to demonstrate the efficacy of Celltexs MSCs as a prophylactic therapy for those at a high risk of contracting coronavirus to mitigate respiratory, pulmonary and pneumonia co-morbidities.

Celltex has dedicated years to researching safety and efficacy of using its own proprietary MSCs for those suffering from injuries, pain and maladies associated with autoimmune, vascular and other debilitating diseases, including inflammatory lung conditions, pneumonia and chronic obstructive pulmonary disease (COPD). Global studies utilizing MSCs have shown promising results for combatting symptoms and complications associated with COVID-19, and as a leading commercial MSC banking and technology company, Celltex has the unique ability to transition these initial findings into a clinical trial. I am optimistic that our findings will result in favorable outcomes that will improve lives today and for generations to come, said David G. Eller, Celltex Chairman and Chief Executive Officer.

Medistar Corporation and a team of researchers from University of Houston and Texas A&M University worked together to design and fabricate an efficient air disinfection system based on heated nickel (Ni) foam to catch and kill SARS-CoV-2. Virus test results at the Galveston National Laboratory revealed 99.8% of the aerosolized SARS-CoV-2 was caught and killed by a single pass through a Ni-foam-based filter when heated up to 200 C. Additionally, the same filter was also used to catch and kill 99.9% of Bacillus anthracis, an airborne spore. This study paves the way for preventing transmission of SARS-CoV-2 and other highly infectious airborne agents in closed environments, such as schools, daycares, hotels, restaurants, airplanes, office buildings, churches, cruise ships and more. The peer-reviewed study can be found published in Material Physics Today.

Monzer Houranis technology is the only technology proven to catch and kill actual SARS-CoV-2 on contact, instantaneously. When deployed, this technology will have a dramatic impact in helping decrease indoor transmission of COVID-19 and other biological pathogens, said Dr. Garrett Peel, MD, Executive VP of Medistar Corporation & Founding Partner of Integrated Viral Protection.

ABOUT CELLTEX THERAPEUTICS

Founded in 2011, Celltex Therapeutics Corporation is a Houston, Texas-based biotechnology company and a pioneer in Mesenchymal Stem Cell (MSC) technology. The company is the nations leading commercial MSC banking company and focuses on spearheading breakthroughs in regenerative medicine using MSCs. Celltex uses its own proprietary technology to isolate, cryopreserve and culture hundreds of millions of superior grade MSCs in its state-of-the-art, current Good Manufacturing (cGMP) and FDA-compliant laboratory. Celltex-produced MSCs are used in regenerative therapies for injuries and chronic pain, as well as many other conditions, including vascular, degenerative and autoimmune diseases. Celltexs intellectual property (IP) portfolio encompasses over 1,500 clients, who have received over 9,000 MSC therapies for various diseases without incurring any adverse events. To learn more about Celltex, visit http://www.celltexbank.com.

ABOUT MEDISTAR CORPORATION

Medistar Corporation is a real estate development company headquartered in Houston, Texas. As it has for over 45 years, Medistar specializes in the development, financing and acquisition of real estate across the United States. Complementing its longstanding focus of medical real estate development, Medistar actively develops multifamily, hospitality, entertainment, commercial, and mixed-use projects. In Houston, Medistar is developing the iconic 50-story Innovation Tower to complement its recently completed 35-story, 374-unit LATITUDE Med Center apartment tower and 22-story, 353-key InterContinental Houston Medical Center hotel at the Texas Medical Center. Please visit http://www.medistarcorp.com/ for more information.

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Former U.S. Secretary of Energy and Texas Governor, Rick Perry, Names Two Texas Companies as Leading Innovators in the Fight Against COVID-19 -...

COVID-19 Analysis | Stromal Vascular Fraction Market by Trends, Dynamic Innovation in Technology and 2019 to 2029 Forecasts – 3rd Watch News

Stromal vascular fraction is gaining significant importance in various fields, including internal medicine, orthopaedics, plastic and general surgery,and wound healing.

Ease of harvest, abundant availability, and stable phenotype are some factors increasing the demand for stromal vascular fraction. Also, stromal vascular fraction secretes several soluble factors with anti-inflammatory, immunomodulatory, and analgesic effects, which leads to an alternative treatment option for various diseases, significantly benefitting the growth of thestromal vascular fraction marketduring the forecast period.

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Company Profiles

Delivery of stromal vascular fraction by intra-articular injection has advantages over surgical implantation, such as less invasiveness, better patient compliance, and lower cost.

The global stromal vascular fraction market was valued atUS$ 76 Mnin 2018, and is expected to witness a CAGR of around4%over the forecast period (2019-2029).

Key Takeaways of Stromal Vascular Fraction Market Study

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Stromal vascular fraction has emerged as an efficient alternative in the field of regenerative medication. However, better-structured and significant clinical investigations need to be carried out to demonstrate and define the therapeutic potential of stromal vascular fraction,says a PMR analyst.

Stromal Vascular Fraction Manufacturers Focusing on Innovative Methods to Optimize Tissue Recovery

Consistent up-gradation and innovation in methods to recover adipose tissue-derived mesenchymal stem cells (ATD-MSCs) for autologous use in regenerative medication applications are expected to offer significant opportunities for the stromal vascular fraction market.

For instance, LipoCell from Tissyou, is furnished with a semipermeable film that separates fat tissues from squander components with the assistance of continuous irrigation. The dialysis of the tissue limits the pressure and trauma to the cell and extracellular matrix, evacuating the blood and oil deposits, which are pro-inflammatory.

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More Valuable Insights on Stromal vascular fraction Market

Persistence Market Research brings a comprehensive research report on the forecasted revenue growth at global, regional, and country levels, and provides an analysis of the latest industry trends in each of the segments from 2014 to 2029.

The global stromal vascular fraction market is segmented in detail to cover every aspect of the market and present a complete market intelligence approach to the reader.

The study provide compelling insights on the stromal vascular fraction market on basis of product (SVF isolation products, SVF aspirate purification products, and SVF transfer products), application (cosmetic applications, orthopedic applications, soft tissue applications, and others), and end user (hospitals, ambulatory surgical centers, stem cell laboratories, and others), across six major regions.

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COVID-19 Analysis | Stromal Vascular Fraction Market by Trends, Dynamic Innovation in Technology and 2019 to 2029 Forecasts - 3rd Watch News

Advanced Therapy Medicinal Products Market Break Down By Leading Companies, Countries, Applications, Challenges, Opportunities And Forecast 2020-2026…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Advanced Therapy Medicinal Products market.

Trusted Business Insights presents an updated and Latest Study on Advanced Therapy Medicinal Products Market 2019-2026. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Advanced Therapy Medicinal Products market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

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Industry Insights, Market Size, CAGR, High-Level Analysis: Advanced Therapy Medicinal Products Market

The global advanced therapy medicinal products market size was valued at USD 3.14 billion in 2019 and is projected to expand at a CAGR of 17.4% during the forecast period. Recent advancements in biological therapies have resulted in a gradual shift toward personalized medicine from the conventional one-size fits all approach. The advanced therapy medicinal product (ATMP) landscape is one of the active spaces in this new trend. These products offer solutions for conditions with negligible therapeutic alternatives as well, which is one of the major growth drivers for the market. Although the regulation for ATMPs is currently in its nascent stage, it is a constantly developing area. The number of Investigational New Drug (IND) applications for these therapies continues to increase. Post-approval of Yescarta, Center for Biologics Evaluation and Research has received around 150 INDs in fiscal year 2018. According to the Alliance for Regenerative Medicine (ARM), more than 1,000 clinical trials were carried out for the ATMP designation to the products, by January 2019, globally.

With the approval of Luxturna, Yescarta, and Kymriah, this market has witnessed several acquisitions intended for market entry or expansion in the sector. For example, acquisition of Kite Pharma by Gilead Life Science, Juno Therapeutics by Celgene, and AveXis by Novartis are some of the notable acquisitions that took place in recent times. These acquisitions indicate the rising interest of major pharma companies in advanced therapy medicinal products. Although the companies have successfully secured product approvals in the past years, the high cost of therapies and challenges with respect to financial sustainability are anticipated to slowdown product adoption. Several products have been pulled off from the market as they were not considered financially viable for the developers as well as the payers. Moreover, some companies like Fibrocell have also witnessed the wind-down of their product operations. Despite the above-articulated challenges, this field is constantly expanding owing to the health benefits offered by these new classes of therapies, along with benefitting society and the healthcare system in context to healthcare outcome and resource availability. Considering the efficiency and clinical benefits of advanced therapy medicinal products, various stakeholders of the market are constantly designing strategies to overcome the existing challenges and spur advanced therapy medicinal products usage. Therapy Type Insights of Advanced Therapy Medicinal Products Market

Over the past few years, there has been a notable increase in the clinical development of advanced therapies, including gene therapies, cell therapies, and tissue engineering products. Several products have already secured approval in U.S., China, Europe, South Korea, Japan, Australia, Canada, India, and New Zealand. As a result, a substantial number of well-established as well as start-up pharma companies, universities, and hospitals are shifting their focus from conventional therapies to advanced therapies. Cell therapies held the largest revenue share of the advanced therapy medicinal products market in 2019. Increased funding from governments as well as private organizations to support cell therapy clinical trials, improving the legal framework for cell therapy manufacturing and implementation, and proven efficacy of products are some of the key drivers for the growth of the segment.

Based on cell types, stem cell therapies held the dominant revenue share in 2019 owing to the presence of a substantial number of approved therapies. The entry of new players such as Celularity, Rubius Therapeutics, Century Therapeutics, Fate Therapeutics, ViaCyte, Magenta Therapeutics, ReNeuron, Promethera Biosciences, Frequency Therapeutics, and Cellular Dynamics in the recent years reflects the expanding stem cells business operations. Currently, the number of approved gene therapy is limited, however, a substantial number of products is anticipated to receive regulatory approvals in the forthcoming years. Growing R&D activities in gene therapy trials have resulted in an increase in market activities by the key stakeholders operating in the ATMP market. For instance, in April 2019, Catalent announced to acquire Paragon Bioservices to expand its business footprint in the gene therapy arena.

Regional Insights of Advanced Therapy Medicinal Products Market

The presence of a substantial number of approved ATMPs for use in U.S. has contributed to the large revenue share of this region. The recent approval of products like Kymriah, Yescarta, and Zolgensma has propelled the investment in the U.S. ATMP market. Furthermore, the U.S. FDA has announced that it has over 800 active Investigational New Drug applications on file by 2020 and the agency showed interest to receive more than 200 applications per year. In 2017, an estimated 391 gene therapy companies were operating in the U.S. market. In September 2019, around a hundred more companies including Big Pharma companies had entered the market. These factors are anticipated to accelerate the North America market at a lucrative CAGR in the forthcoming years. Europe is the second-largest pharmaceutical market globally, with Western Europe accounting for the large proportion of drug revenue. In the forthcoming years, cell therapy developers are anticipated to account for a major share of Europes drug revenues. In addition, the presence of a substantial number of academic institutes engaged in conducting early-stage cell therapy research is anticipated to boost the regional revenue growth. Furthermore, global companies are expanding their cell therapy manufacturing capabilities across Europe, thereby driving the regional market growth.

Market Share Insights of Advanced Therapy Medicinal Products Market

Currently, this market is a very active space. Recent approvals of ATMPs have prompted an unprecedented expansion in this area. Conventional drug makers are striving to gain a competitive advantage, considering ATMP as a lucrative source of revenue in the future healthcare systems. Companies are investing enormously in clinical trials of ATMP post the success of approved products. Some major players are Spark Therapeutics, Inc.; Bluebird Bio, Inc.; Novartis AG; UniQure N.V.; Celgene Corporation; Gilead Lifesciences, Inc.; Kolon TissueGene, Inc.; JCR Pharmaceuticals Co., Ltd.; MEDIPOST; Vericel Corporation; PHARMICELL Co., Ltd; and Organogenesis Inc. The companies are adopting various operating models to accelerate the product manufacturing process. While some companies undertake in-house production of therapies, a substantial number of players are preferring third-party service providers, including Contract Manufacturing Organizations (CMOs). The gene therapy contract development market space is driven by the surging demand that stems from the expansion of drug development pipeline and the rise in the number of start-ups that embrace human-testing but lack production capacities. On the other hand, several companies have marked their presence in the space by acquiring small and emerging CAR T-cell therapy developers.

Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Advanced Therapy Medicinal Products Market Research Report This report forecasts revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, this market research report has segmented the global advanced therapy medicinal products market report on the basis of therapy type and region:

Therapy Type Outlook (Revenue, USD Million, 2019 2030)

Cell Therapy

Stem Cell Therapy

Non-stem Cell Therapy

CAR-T Therapy

Gene Therapy

Tissue Engineered Product

Quick Read Table of Contents of this Report @ Advanced Therapy Medicinal Products Market Market Research and Industry Forecast Report, 2026 (Includes Business Impact of COVID-19)

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Advanced Therapy Medicinal Products Market Break Down By Leading Companies, Countries, Applications, Challenges, Opportunities And Forecast 2020-2026...

Critically ill COVID-19 Patient Successfully Treated with Vitro Biopharma’s AlloRx Stem Cells(R) – BioSpace

GOLDEN, CO / ACCESSWIRE / July 14, 2020 / Vitro Diagnostics, Inc. (OTC PINK:VODG), dba Vitro Biopharma, jointly with GIOSTAR - a San Diego, California-based institution headed by Dr. Anand Srivastava, a pioneer in stem cell science - announced the results of treatment of a critically ill COVID-19 patient with its lead clinical product AlloRx Stem Cells.

This patient was admitted to an emergency room with classic COVID-19 symptoms in late April and had several comorbidities prior to admission. While intubated in the intensive care unit (ICU), the patient's condition worsened using the standard of care and treatment with convalescent plasma. The patient's kidney and liver function began to fail, requiring dialysis. Additionally, the patient experienced sepsis and a stroke while in the ICU and was comatose for almost 7 weeks.

Following the treatment with AlloRx Stem Cells, the patient experienced resolution of multiple organ failure, recovery from coma, and restoration of neurological, pulmonary, liver and renal function. The patient was removed from assisted respiration and dialysis. The patient now eats, drinks, speaks, and has regained motor function. Measures of inflammation that were elevated at admission and rose during ICU treatment, returned to normal levels. The patient has recently been discharged from ICU and is currently undergoing physical therapy to recover from the stroke suffered while in the ICU.

This study was authorized by the FDA through an Investigational Drug Application (eIND) for emergency use under expanded access granted to GIOSTAR, Vitro Biopharma's partner in stem cell therapy for COVID-19 using AlloRx Stem Cells as the therapeutic agent. GIOSTAR Medical Director Dr. Prabhat Soni oversaw the clinical management of the patient and all related clinical/regulatory issues. Vitro Biopharma is pleased to partner with GIOSTAR to provide expanded offerings of AlloRx Stem Cell COVID-19 therapy to its expanding global clientele, while at the same time expanding treatment to US COVID-19 patients through eIND and pending INDs.

Dr. Anand Srivastava, MS, PhD, GIOSTAR's Chairman and Chief Scientific Officer said "COVID-19 infection triggers the spectrum of inflammatory cytokines, which results in severe COVID-19 induced pneumonia and acute respiratory distress syndrome (ARDS), followed by multiple organ failure. Utilizing the natural immunomodulatory character of AlloRx Stem Cell (Mesenchymal Stem Cells or MSCs) may be one of the best ways to neutralize COVID-19 induced inflammatory cytokines actions on lung and other organs to rescue the patients suffering from COVID-19 infection."

Dr Jack Zamora, MD, Vitro Biopharma's Chief Medical Advisor said, "The miraculous recovery of our first critically ill COVID-19 patient using AlloRx Stem Cells bring great hope in these troubling times. We continue with our FDA IND application with even greater hope of delivering a promising treatment to US patients, and through GIOSTAR, we have reached out to various Ministries of Health worldwide with this promising news."

"We are pleased to have achieved this milestone that was based on thorough understanding of the science of stem cell biology," said Dr Jim Musick, CEO of Vitro Biopharma. "While regeneration of destroyed cells is a common effect of stem cell therapy, stem cells also regenerate damaged cells by various regenerative processes that restore normal organ function. The results of this case support the further study of AlloRx Stem Cell Therapy for COVID-19 patients and other conditions characterized by acute respiratory distress that are ultimately related to the inflammatory cytokine cascade that is neutralized by AlloRx Stem Cells. Our therapy appears to have significant therapeutic application in treatment of multi-organ failure related to COVID-19 infections."

"The results with this patient are quite remarkable," stated Dr. Soni, Chief Medical Officer, Giostar, Inc. "It is highly likely that the patient would have died without stem cell therapy, because the combination of organ failure and comorbidities yielded a very poor prognosis. We are pleased to partner with Vitro Biopharma and look forward to providing this therapeutic option for slowing the pandemic on a global scale."

About Vitro Biopharma:

Out of years of research, we developed our patent-pending and proprietary line of umbilical cord derived stem cells AlloRx Stem Cells now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands http://www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas http://www.tmp-bahamas.com in Nassau.

Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Chrohn's disease and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.

CONTACT:

Dr. James Musick Chief Executive Officer Vitro Biopharma (303) 550-2778 E-mail: jim@vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/597400/Critically-ill-COVID-19-Patient-Successfully-Treated-with-Vitro-Biopharmas-AlloRx-Stem-CellsR

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Critically ill COVID-19 Patient Successfully Treated with Vitro Biopharma's AlloRx Stem Cells(R) - BioSpace

Global Induced Pluripotent Market 2020 Analysis with COVID-19 Effects|Astellas Pharma Inc.; Thermo Fisher Scientific; Cell Applications, Inc.; Axol…

Few of the major competitors currently working in the induced pluripotent market are Bristol-Myers Squibb Company; CELGENE CORPORATION; Astellas Pharma Inc.; Thermo Fisher Scientific; Cell Applications, Inc.; Axol Bioscience Ltd.; Organogenesis Holdings; Merck KGaA; FUJIFILM Holdings Corporation; Fate Therapeutics; KCI Licensing, Inc.; Japan Tissue Engineering Co., Ltd.; Vericel; ViaCyte, Inc.; STEMCELL Technologies Inc.; Horizon Discovery Group plc; Lonza; Takara Bio Inc.; Promega Corporation and QIAGEN.

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Key questions answered in the Global Induced Pluripotent Market report include:

Market Drivers

Market Restraints

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Segmentation: Global Induced Pluripotent Market

By Product Category

By Cell Type

By Application

By End-User

By Geography

Key Developments in the Market:

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Global Induced Pluripotent Market 2020 Analysis with COVID-19 Effects|Astellas Pharma Inc.; Thermo Fisher Scientific; Cell Applications, Inc.; Axol...

FDA Approves Talaris Therapeutics’ IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderma – Business…

BOSTON & LOUISVILLE, Ky.--(BUSINESS WIRE)--Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, announced that the U.S. Food and Drug Administration (FDA) has approved the companys Investigational New Drug (IND) application for the evaluation of Talaris novel cell therapy FCR001 in the treatment of diffuse systemic sclerosis (SSc), a severe form of the rare autoimmune disease scleroderma. Approval of this IND allows Talaris to initiate a Phase 1/2a trial at sites across the U.S., including Duke University and the University of Michigan.

Were very eager to study the tolerogenic potential of FCR001 for patients with severe autoimmune disease, said Scott Requadt, Chief Executive Officer of Talaris. Individuals with diffuse cutaneous systemic sclerosis, a subset of scleroderma with high morbidity and mortality, are in great need of safe and effective, disease-modifying, treatment options. We believe FCR001 could represent an important new approach to treating this serious condition.

Scleroderma, which derives from the Greek words sclero, meaning hard, and derma, meaning skin, is a rare and potentially fatal chronic autoimmune disease which causes progressive scarring, or fibrosis, of the bodys connective tissues. Scleroderma can either be localized or systemic. Systemic scleroderma, also called systemic sclerosis (SSc), is further divided into the limited cutaneous subset and the diffuse cutaneous subset, depending on the degree of skin involvement. Both types affect the skin and vital internal organs, especially the lungs, kidneys, gut and heart, resulting in organ dysfunction. Patients with the diffuse subset generally have rapidly progressive skin and internal organ involvement and have worse outcomes than the limited subtype.

Based on encouraging data from randomized clinical trials, autologous hematopoietic stem cell transplant (HSCT) is increasingly used to treat severe cases of diffuse cutaneous SSc, where it has been shown to halt organ damage and induce clinical remission. However, because patients are transplanted with their own stem cells, there is a risk of disease recurrence, and patients typically must first undergo full myeloablative conditioning with or without total body irradiation, which is associated with direct organ toxicity and increased risk of future cancers.

Talaris allogeneic cell therapy, FCR001, is a novel, one-time treatment intended to induce immune tolerance in the recipient and which can be used across all levels of donor-recipient HLA mismatch. Treatment with FCR001 is preceded by non-myeloablative conditioning. In a Phase 2 clinical trial in de novo living donor kidney transplant recipients, FCR001 resulted in durable immune tolerance in 70% of the 37 recipients treated; these individuals were able to successfully discontinue their anti-rejection medications and no tolerized patient has had to resume immunosuppression (median follow-up of over 5 years, longest follow-up is over 10 years). Furthermore, seven of the successfully tolerized patients had kidney failure due to an underlying autoimmune disease, and none of these patients has experienced recurrence of their underlying autoimmune disease post-treatment. Based on these encouraging data and its broad therapeutic potential in autoimmune disease, FCR001 will be evaluated in a planned Phase 1/2a trial of patients with diffuse cutaneous SSc.

A safe, allogeneic stem cell transplant treatment using nonmyeloablative conditioning could offer important additional benefits over current autologous HSCT as a treatment for this severe form of systemic sclerosis, said Keith Michael Sullivan, M.D., Professor of Medicine at Duke University Medical School.

The diffuse cutaneous systemic sclerosis subset I see in my practice have very limited treatment options. Autologous stem cell transplant has demonstrated the potential to induce durable remissions in randomized clinical trials, but involves significant risks to the patients, said Dinesh Khanna, M.D., M.Sc., Director of the Scleroderma Program and Professor of Medicine at the University of Michigan Medical School. I am excited to participate in this clinical trial of FCR001, and hopeful that it could result in a safer and more durably effective treatment for these patients.

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients immune tolerance. FCR001 builds on over 30 years of research by the companys founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients, FREEDOM-1, is now enrolling patients; more information can be found at: http://freedom1study.com/

About Talaris Therapeutics

Talaris Therapeutics, Inc. is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe auto-immune and immune-mediated disorders. Talaris was founded on technology discovered and developed by Dr. Suzanne Ildstad and operates its own cell processing facility in Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA and maintains corporate offices in Boston, MA and Louisville, KY. http://www.TalarisTx.com.

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FDA Approves Talaris Therapeutics' IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderma - Business...

New Comprehensive Report on Cell Expansion Technologies Market to Witness an Outstanding Growth during 2020 2025 with Top Players Like ReNeuron,…

Latest Research Report: Cell Expansion Technologies industry

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

Global Cell Expansion Technologies Market documents a detailed study of different aspects of the Global Market. It shows the steady growth in market in spite of the fluctuations and changing market trends. The report is based on certain important parameters.

Depending upon the type of cell, the global cell expansion market can be broadly split into human cells and animal cells. The human cell can be further divided into stem cells and differentiated cells. Revenue-wise, the human stem cell segment accounts for a dominant share in the market on account of the rising prevalence of various chronic diseases and support provided by the government. In 2016, it held a substantial 58.1% share in the overall revenue in the global cell expansion market.

Geographically, the key segments of the market are Asia Pacific, Europe, North America, Latin America, and the Middle East and Africa. Among them, North America is the leading market on account of the concentration of many key players in the region and the increasing research and development in the field. Going forward, North America is slated to slightly pare its market share to hold a 37.7% share in it by 2024. It will still, however, remain the dominant market.

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Cell Expansion Technologies Market competition by top manufacturers as follow: , Becton, Dickinson, GE Healthcare, Thermo Fisher Scientific Inc., Corning Inc, Danaher Corp, Merck Millipore, Terumo BCT, STEMCELL Technologies, Sigma-Aldrich Corp, Miltenyi Biotec, Life Technologies, Replicell, Neximmune, TC Biopharm, Pluristem Therapeutics, ReNeuron, Voria Biomaterials, CellProthera, Cytomatrix

The risingtechnology in Cell Expansion Technologiesmarketis also depicted in thisresearchreport. Factors that are boosting the growth of the market, and giving a positive push to thrive in the global market is explained in detail. It includes a meticulous analysis of market trends, market shares and revenue growth patterns and the volume and value of the market. It is also based on a meticulously structured methodology. These methods help to analyze markets on the basis of thorough research and analysis.

The Type Coverage in the Market are: Reagents Media Sera Disposables

Market Segment by Applications, covers: Clinical diagnostics Drug discovery and development Regenerative medicine Others

The research report summarizes companies from different industries. This Cell Expansion Technologies Market report has been combined with a variety of market segments such as applications, end users and sales. Focus on existing market analysis and future innovation to provide better insight into your business. This study includes sophisticated technology for the market and diverse perspectives of various industry professionals.

Cell Expansion Technologies is the arena of accounting worried with the summary, analysis and reporting of financial dealings pertaining to a business. This includes the training of financial statements available for public ingesting. The service involves brief, studying, checking and reporting of the financial contacts to tax collection activities and objects. It also involves checking and making financial declarations, scheming accounting systems, emerging finances and accounting advisory.

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Market segment by Regions/Countries, this report covers North America Europe China Rest of Asia Pacific Central & South America Middle East & Africa

Report Highlights: Detailed overview of parent market Changing market dynamics in the industry In-depth market segmentation Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape Strategies of key players and products offered Potential and niche segments, geographical regions exhibiting promising growth A neutral perspective on market performance Must-have information for market players to sustain and enhance their market footprint

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New Comprehensive Report on Cell Expansion Technologies Market to Witness an Outstanding Growth during 2020 2025 with Top Players Like ReNeuron,...

Why are scientists trying to manufacture organs in space? – TNW

Gravity can be a real downer when you are trying to grow organs.

Thats why experiments in space are so valuable. They have revealed a new perspective into biological sciences, including insights into making human tissues.

Gravity influences cellular behavior by impacting how protein and genes interact inside the cells, creating tissue that is polarized, a fundamental step for natural organ development. Unfortunately, gravity is against us when we try to reproduce complex three dimensional tissues in the lab for medical transplantation. This is difficult because of the intrinsic limitations of bio-reactors used on Earth.

I am a stem cell biologist and interested on brain health and evolution. My lab studies how the human brain is formed inside the womb and how alterations in this process might have lifelong consequences to human behavior, such as in autism or schizophrenia. Part of that work includes growing brain cells in space.

To build organized tissues in the lab, scientists use scaffolds to provide a surface for cells to attach based on a predetermined rigid shape. For example, an artificial kidney needs a structure, or scaffold, of a certain shape for kidney cells to grow on. Indeed, this strategy helps the tissue to organize in the early stages but creates problems in the long run, such as eventual immune reactions to these synthetic scaffolds or inaccurate structures.

By contrast, in weightless conditions, cells can freely self-organize into their correct three-dimensional structure without the need for a scaffold substrate. By removing gravity from the equation, we researchers might learn new ways of building human tissues, such as cartilage and blood vessels that are scaffold-free, mimicking their natural cellular arrangement in an artificial setting. While this is not exactly what happens in the womb (after all the womb is also subject to gravity), weightless conditions does give us an advantage.

And this is precisely what is happening at the International Space Station.

These experiments help researchers optimize tissue growth for use in basic science, personalized medicine and organ transplantation.

But there are other reasons why we should manufacture organs in space. Long-term space missions create a series of physiological alterations in the body of astronauts. While some of these alterations are reversible with time, others are not, compromising future human spaceflights.

Studying astronauts bodies before and after their mission can reveal what goes wrong on their organs, but provides little insights on the mechanisms responsible for the observed alterations. Thus, growing human tissues in space can complement this type of investigation and reveal ways to counteract it.

Finally, all forms of life that we know about have evolved in the presence of microgravity. Without gravity, our brains might have evolved in a different trajectory, or our livers might not filter liquids as it does on Earth.

By recreating embryonic organ formation in space, we can anticipate how the human body in the womb would develop. There are several research initiatives going on in my lab with human brain organoids at ISS, designed to learn the impact of zero gravity on the developing human brain. These projects will have profound implications for future human colonization (can humans successfully reproduce in space?). These studies will also improve the generation of artificial organs that are used for testing drugs and treatments on Earth. Will better treatments for neurodevelopmental and neurodegenerative conditions that affects millions of people come from research in space?

This article is republished from The ConversationbyAlysson R. Muotri, Professor of Pediatrics and Cellular and Molecular Medicine, University of California San Diegounder a Creative Commons license. Read the original article.

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Why are scientists trying to manufacture organs in space? - TNW

Biobanks Market Analysis Trends, Growth Opportunities, Size, Type, Dynamic Demand and Drives with Forecast to 2025 – Daily Research Chronicles

The global biobanks market owes its conception to the rising need for replacement organs and the steady advancement in the replacement and transfusion technologies regarding a number of bodily substances. Though the technology and need to store organs and other bio-entities had been available for a long time, the global biobanks market took on a more important role in the healthcare sector following the increasing research in genomics. In the new millennium, the development of the personalized medicine field has been the vital driver for the global biobanks market. The likely advancement of the latter, thanks to helpful government regulations, is likely to make the crucial difference for the global biobanks market in the near future.

The steady technological advancement in the healthcare sector in the last few decades has now led to a scenario where the full potential of biobanks can be harnessed. As a result, the global biobanks market is projected to exhibit steady growth over the coming years.

Global Biobanks Market: Key Trends

The rising interest in personalized medicine is the prime driver for the global biobanks market. Personalized medicine has only become a viable branch of modern medicine after steady research in genomics and the way various patients react to various medicines. The biobanks market has thus come into the spotlight thanks to their role as a steady supplier of human biomaterials for research as well as direct application. The increasing research in genomics following the findings of the Human Genome Project is thus likely to remain a key driver for the global biobanks market in the coming years.

The utilization of biobanks in stem cell research has been hampered in several regions by ethical concerns regarding the origin of stem cells. Nevertheless, the potential of stem cells in the healthcare sector is immense, and is likely to have a decisive impact on the trajectory of the global biobanks market in the coming years. Many countries have, in recent years, adopted a supportive stance towards stem cell research, aiding the growth of the biobanks market. Continued government support is thus likely to remain vital for the global biobanks market in the coming years.

Global Biobanks Market: Market Potential

The leading role of the U.S. in the global biobanks market is unlikely to change in the coming years. The easy availability of government-supported healthcare infrastructure and the presence of several industry giants in the region has driven the biobanks market in the U.S.

Northwell Health, the largest healthcare provider in New York State, earlier in 2017 initiated a new biobank aimed at creating precision therapies against various types of cancer. Launched in collaboration with Indivumed, the biobank will provide catalogued biomaterials for research into lung, colorectal, breast, and pancreatic cancer. This would enable targeted, gene-specific studies of a variety of cancer samples, leading to a more comprehensive understanding of cancer. Such well-funded collaboration efforts are crucial for the developing biobanks market.

Global Biobanks Market: Geographical Dynamics

Led by the fertile healthcare research scenario in the U.S., North America is likely to retain a dominant share in the global biobanks market in the coming years. Steady support from institutes such as the NIH is likely to be vital for the North America biobanks market.

Emerging Asia Pacific economies such as India and China could emerge with a significant share in the global biobanks market in the coming years. The healthcare sector in both countries has received steady public or private funding in the last few years. India is also a global leader in medical tourism and is likely to receive an increasing number of patients in the coming years, leading to promising prospects for the global biobanks market in the region.

Global Biobanks Market: Competitive Dynamics

Due to the dynamic nature of the global biobanks market, with advancements in diagnostic fields often determining the direction of the market, the market is heavily fragmented. It is likely to retain a significant degree of fragmentation in the coming years thanks to the diversity in the application segments of the biobanks market. The leading players in the global biobanks market includeBioCision, Tecan Group, VWR, Beckman Coulter Inc., and Thermo Fisher Scientific.

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Biobanks Market Analysis Trends, Growth Opportunities, Size, Type, Dynamic Demand and Drives with Forecast to 2025 - Daily Research Chronicles