Mesoblast’s remestemcel-L receives FDA IND clearance for treating COVID-19 patients with acute respiratory distress – Small Caps

Regenerative medicine company Mesoblast (ASX: MSB) has received US Food and Drug Administration Investigational New Drug (IND) clearance for its remestemcel-L treatment to be used in COVID-19 patients presenting with acute respiratory distress syndrome.

According to Mesoblast chief medical officer Dr Fred Grossman, the FDA IND approval now enables US-based COVID-19 patients with poor prognosis to be treated with remestemcel-L under compassionate usage grounds and in a planned randomised controlled trial.

Remestemcel-L is an anti-inflammatory treatment that has been developed for use in various inflammatory conditions including steroid-refractory acute graft versus host disease.

Mesoblast claims the drug works by counteracting the inflammatory processes in these diseases by down-regulating the production of pro-inflammatory cytokines, while boosting production of anti-inflammatory cytokines and enabling recruitment of the ant-inflammatory cells to the involved tissues.

To-date, the safety and therapeutic impact of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in clinical trials.

In a phase 3 trial, remestemcel-L was found useful in treating acute graft versus host disease, which Mesoblast claims produces a similar cytokine storm process as seen in COVID-19 patients with acute respiratory distress syndrome.

Additionally, post hoc analysis of a previous study involving 60 patients with chronic obstructive pulmonary demonstrated remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also seen in COVID-19 acute respiratory distress syndrome patients.

COVID-19 patients most at risk of developing acute respiratory distress syndrome include the elderly and those with co-morbidities such as diabetes.

According to Mesoblast, patients with COVID-19 that have developed acute respiratory distress syndrome have an almost 50% fatality rate.

Remestemcel-L is an allogeneic mesenchymal stem cell product, with preliminary data from China indicating allogeneic mesenchymal stem cells have either cured or significantly improved functional outcomes for seven patients with COVID-19 in the small trial.

By mid-morning trade, Mesoblasts shares were up almost 30% to $1.74.

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Mesoblast's remestemcel-L receives FDA IND clearance for treating COVID-19 patients with acute respiratory distress - Small Caps

Stem Cell Therapy for Colon Cancer – The Ritz Herald

An article published in Experimental Biology and Medicine(Volume 245, Issue 6, March 2020)examines the safety of stem cell therapy for the treatment of colon cancer.The study, led by Dr. J. Liu in the State Key Laboratory of Bioreactor Engineering and Shanghai Key Laboratory of New Drug Design at the East China University of Science and Technology in Shanghai (China), reports that mesenchymal stem cells from a variety of sources promote the growth and metastasis of colon cancer cells in an animal model.

Mesenchymal stem (MSCs), a category of adult stem cells, are being evaluated as a therapy for numerous cancers.MSCs are excellent carriers for tumor treatment because they migrate to tumor tissues, can be genetically modified to secrete anticancer molecules and do not elicit immune responses.Clinical trials have shown that MSCs carrying modified genes can be used to treat colon cancer as well as ulcerative colitis. However, some studies have demonstrated MSCs can differentiate into cancer-associated fibroblasts and promote tumor growth.Therefore, additional studies are needed to evaluate the safety of MSCs for targeted treatment of colon cancer.

In the current study, Dr. Liu and colleagues examined the effects of mesenchymal stem cells (MSCs) from three sources (bone marrow, adipose, and placenta) on colon cancer cells.MSCs from all three sources promoted tumor growth and metastasis in vivo. In vitro studies demonstrated that MSCs promote colon cancer cell stemness and epithelial to mesenchymal transition, which would enhance tumor growth and metastasis respectively.Finally, the detrimental effects of MSCs could be reversed by blocking IL-8 signaling pathways. Dr. Ma, a co-author of the study, said that Mesenchymal stem cells have a dual role: promoting and/or suppressing cancer. Which effect is dominant depends on the type of tumor cell, the tissue source of the MSC and the interaction between the MSC and the cancer cell. This is the major issue in the clinical application research of MSCs, and additional preclinical experimental data will be needed to evaluate the safety of MSCs for colon cancer treatment.

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said: Lui and colleagues have performed elegant studies on the impact of mesenchymal stem cells (MSCs), from various sources, upon the proliferation, stemness, and metastasis of colon cancer stem cells (CSCs) in vitro and in vivo. They further demonstrate that IL-8 stimulates the interaction between colon CSCs and MSCs, and activates the MAPK signaling pathway in colon CSCs.This provides a basis for the further study of MSCs as a biologic therapy for colon cancer.

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit sebm.org.

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Symtomax: the science behind producing high quality medical cannabis – Health Europa

Indeed, such research has enabled consumers to look beyond the assumption that all forms of cannabis will make them high an assumption attributed to tetrahydrocannabinol (THC), the psychoactive compound within the cannabis plant. Now, non-psychoactive compounds such as Cannabidiol (CBD) are starting to enter consumer markets in a variety of products such as vapes, edibles, and dietary supplements.

However, the cannabis plant (Cannabis Sativa), has not solely been used for recreational purposes. For thousands of years, cannabis has been used in ancient medicine for its pain-relieving qualities. At the present time, medical research has suggested that cannabinoids can be used by a large number of patients worldwide to lessen the symptoms of conditions as wide-ranging as anxiety and Parkinsons disease, to migraines and multiple sclerosis.

With the prevalence of medicinal cannabis on the up, the cannabis industry is changing, which begs the question how is it produced, and what should we as an industry be doing to ensure that the manufacture of medicinal cannabis is always of the highest possible quality?

Many would point towards cultivation as an important factor in the production of high-quality medicinal cannabis.

In order for medical cannabis to thrive, certain environmental conditions are required for optimal growth; these include overall air quality, genetics, adequate light, temperature, humidity, soil and water quality.

There is a reason that California in particular is hailed as a hub for the medical cannabis industry; its greatest asset is its warm climate, rich soil and abundant sunlight all which make the outdoor production of high-quality cannabis a viable prospect. This of course is a very similar climate to Portugal, where Symtomax have started the development of their medical cannabis cultivation facility, an enormous 105-hectare site in the Alentejo region of the country.

Of course, similar conditions can be replicated using greenhouses, where ventilation then becomes the most crucial factor. The right ventilation prevents the growth of mildew, or mould, and overheating, so an intake and outtake fan on the ceiling or the top of the grow room are required for adequate ventilation.

Likewise, temperature is also a crucial factor. The ideal temperature for a medical cannabis plant to grow tends to be between 20 and -30 degrees Celsius; such conditions mean they are able to grow stronger and thicker stems, with denser buds. At temperatures below 15 degrees Celsius, plant growth begins to slow, so it is crucial that this is monitored closely.

Indeed, more and more companies are understanding the benefits in investing in state-of-the-art greenhouses, to create the best conditions for cannabis growth. For example, Symtomax has recently begun work on new greenhouses with advanced engineering work to ensure all cannabis plants receive optimal growing conditions.

However, producing the highest quality medicinal cannabis doesnt stop at the growing stage. Indeed, given the vast array of potential health benefits, experts are always in the process of conducting new studies into the cannabis plant itself, so that manufacturers and health professionals alike can better understand its properties. In particular, research into lesser known cannabinoids and the qualities they possess are key drivers in the improvement of medicinal cannabis quality.

CBD (cannabidiol) is one of the most common compounds (also known as a cannabinoid), and has been found to possess anti-inflammatory, calming and pain-relieving properties due to its interactions with the serotonin receptors on the brain. As it stands, there is insufficient evidence for CBD to be formally recognised as medicine; that said new studies are emerging every day and consequently, more consumers are experimenting with various CBD products, including oil or edible supplements to relieve ailments.

However, there is more to the cannabis plant than CBD. In recent years, the focus of research is shifting towards other compounds, such as CBG (cannabigerol) and TCHV (tetrahydrocannabivarin). CBG in particular has shown promise as an antibacterial agent and its anti-inflammatory properties. Known widely as the stem cell of cannabis, but despite its vast medical appeal and health benefits, the compound is notoriously expensive to produce.

Consequently, CBG is not readily available for the consumer market, meaning that the majority are largely unaware of its potential benefits. That said, with more research being conducted into this cannabinoid, the tides could change over the coming years.

Increasingly, formulation technologies, which act as a bridge between the active components (such as CBD or THC) and the finished products (like CBD oil), are playing an important role in the development of cannabinoid products. Proper formulation strategies lead to products with increased efficacy, better dose control, decreased variability, and increased patient acceptance.

So, knowing the best extraction processes for the right cannabinoids is vital in ensuring the high quality of a product. Likewise, a solid grounding in how different combinations of compounds will most benefit consumers is fundamental to new innovations and discoveries within the industry.

Already, expertise surrounding different formulation technologies have resulted in some exciting innovations. For example, the Symtomax CBD oral tab, which is built on a thin film and adheres to the inside of the cheek. The proprietary technology releases cannabinoids in a controlled, timed manner through the lining of the mouth. Oral Tab can be developed to release doses at different times, so that this method is a practical option for both those needing an instant dose, and those requiring a slower release, over a longer timeframe. The flexibility of time release is therefore improved, as is the quantity of CBD available to enter the blood stream, therefore contributing to better efficiency and systemic absorption rate than any other delivery methods available at present.

All in all, although medicinal cannabis is still a young industry in the western world, and naturally, there is still much research to be done in order to dispel pre-existing taboos and prove its efficacy, there is a lot to be said for its increasing popularity. I look forward to seeing how the industry, and indeed the products, advance over the coming years.

Paul Segal is the Chairman & co-founder of Symtomax. Symtomax have been approved by Infarmed to start the development of Europes largest medical cannabis facility. The organisation is dedicated to the production, research, cultivation, processing and distribution of medicinal cannabis oil to pharmaceutical companies worldwide.

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Global Stem Cell Reconstructive Market- Industry Analysis and Forecast (2020-2027) – Publicist360

Global Stem Cell Reconstructive Market was valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 24.5% during a forecast period.

Global Stem Cell Reconstructive Market

Market Dynamics

The Research Report gives an in-depth account of the drivers and restraints in the stem cell reconstructive market. Stem cell reconstructive surgery includes the treatment of injured or dented part of body. Stem cells are undifferentiated biological cells, which divide to produce more stem cells. Growing reconstructive surgeries led by the rising number of limbs elimination and implants and accidents are boosting the growth in the stem cell reconstructive market. Additionally, rising number of aged population, number of patients suffering from chronic diseases, and unceasing development in the technology, these are factors which promoting the growth of the stem cell reconstructive market. Stem cell reconstructive is a procedure containing the use of a patients own adipose tissue to rise the fat volume in the area of reconstruction and therefore helping 3Dimentional reconstruction in patients who have experienced a trauma or in a post-surgical event such as a mastectomy or lumpectomy, brain surgery, or reconstructive surgery as a result of an accident or injury. Stem cell reconstructive surgeries are also used in plastic or cosmetic surgeries as well. Stem cell and regenerative therapies gives many opportunities for development in the practice of medicine and the possibility of an array of novel treatment options for patients experiencing a variety of symptoms and conditions. Stem cell therapy, also recognised as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.

The common guarantee of all the undifferentiated embryonic stem cells (ESCs), foetal, amniotic, UCB, and adult stem cell types is their indefinite self-renewal capacity and high multilineage differentiation potential that confer them a primitive and dynamic role throughout the developmental process and the lifespan in adult mammal.However, the high expenditure of stem cell reconstructive surgeries and strict regulatory approvals are restraining the market growth.

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Global Stem Cell Reconstructive Market Segment analysis

Based on Cell Type, the embryonic stem cells segment is expected to grow at a CAGR of XX% during the forecast period. Embryonic stem cells (ESCs), derived from the blastocyst stage of early mammalian embryos, are distinguished by their capability to distinguish into any embryonic cell type and by their ability to self-renew. Owing to their plasticity and potentially limitless capacity for self-renewal, embryonic stem cell therapies have been suggested for regenerative medicine and tissue replacement after injury or disease. Additionally, their potential in regenerative medicine, embryonic stem cells provide a possible another source of tissue/organs which serves as a possible solution to the donor shortage dilemma. Researchers have differentiated ESCs into dopamine-producing cells with the hope that these neurons could be used in the treatment of Parkinsons disease. Upsurge occurrence of cardiac and malignant diseases is promoting the segment growth. Rapid developments in this vertical contain protocols for directed differentiation, defined culture systems, demonstration of applications in drug screening, establishment of several disease models, and evaluation of therapeutic potential in treating incurable diseases.

Global Stem Cell Reconstructive Market Regional analysis

The North American region has dominated the market with US$ XX Mn. America accounts for the largest and fastest-growing market of stem cell reconstructive because of the huge patient population and well-built healthcare sector. Americas stem cell reconstructive market is segmented into two major regions such as North America and South America. More than 80% of the market is shared by North America due to the presence of the US and Canada.

Europe accounts for the second-largest market which is followed by the Asia Pacific. Germany and UK account for the major share in the European market due to government support for research and development, well-developed technology and high healthcare expenditure have fuelled the growth of the market. This growing occurrence of cancer and diabetes in America is the main boosting factor for the growth of this market.

The objective of the report is to present a comprehensive analysis of the Global Stem Cell Reconstructive Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.

The report also helps in understanding Global Stem Cell Reconstructive Market dynamics, structure by analysing the market segments and projects the Global Stem Cell Reconstructive Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Stem Cell Reconstructive Market make the report investors guide.Scope of the Global Stem Cell Reconstructive Market

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Global Stem Cell Reconstructive Market, By Sources

Allogeneic Autologouso Bone Marrowo Adipose Tissueo Blood Syngeneic OtherGlobal Stem Cell Reconstructive Market, By Cell Type

Embryonic Stem Cell Adult Stem CellGlobal Stem Cell Reconstructive Market, By Application

Cancer Diabetes Traumatic Skin Defect Severe Burn OtherGlobal Stem Cell Reconstructive Market, By End-User

Hospitals Research Institute OthersGlobal Stem Cell Reconstructive Market, By Regions

North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Stem Cell Reconstructive Market

Osiris Therapeutics NuVasives Cytori Therapeutics Takeda (TiGenix) Cynata Celyad Medi-post Anterogen Molmed Baxter Eleveflow Mesoblast Ltd. Micronit Microfluidics TAKARA BIO INC. Tigenix Capricor Therapeutics Astellas Pharma US, Inc. Pfizer Inc. STEMCELL Technologies Inc.

MAJOR TOC OF THE REPORT

Chapter One: Stem Cell Reconstructive Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Stem Cell Reconstructive Market Competition, by Players

Chapter Four: Global Stem Cell Reconstructive Market Size by Regions

Chapter Five: North America Stem Cell Reconstructive Revenue by Countries

Chapter Six: Europe Stem Cell Reconstructive Revenue by Countries

Chapter Seven: Asia-Pacific Stem Cell Reconstructive Revenue by Countries

Chapter Eight: South America Stem Cell Reconstructive Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Stem Cell Reconstructive by Countries

Chapter Ten: Global Stem Cell Reconstructive Market Segment by Type

Chapter Eleven: Global Stem Cell Reconstructive Market Segment by Application

Chapter Twelve: Global Stem Cell Reconstructive Market Size Forecast (2019-2026)

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Dr. Bart Rademaker Offers Free Classes On Stem Cell Therapy And The Coronavirus – PR Web

Dr. Bart Rademaker Stem Cell Therapy Info, Coronavirus

TAMPA, Fla. (PRWEB) April 02, 2020

Dr. Bart Rademaker, the long-time plastic surgeon who has branched out into stem cell therapy, is offering online classes to patients and doctors who are interested in learning more about regenerative medicine and the potential benefits on health in particular during this time with the coronavirus or COVID-19. Rademaker, has offered the therapy in his office for years and has been contacted by physicians and patients who wish to find out more information on the benefits it could have for those combating the virus as clinical trials are proceeding in many parts of the world.. The classes will be available beginning in April 2020 and include podcasts, blogs and other forms of information that are available online.

The coronavirus has turned the world upside down and people are trying to gather any information they can. Ive heard medical experts tell people to drink warm tea or water every 20 minutes. Ive heard patients say they read that you can kill the virus with stem cell therapy. There is too much information going out there right now and I want to help patients and medical professionals get the facts on it. Based on my experience and my communication with experts in the field of regenerative medicine, I feel that I can offer some assistance. Dr. Bart Rademaker

One of the main things the doctor wishes to stress to people who are unsure how to minimize exposure is that they need to follow the guidelines put in place by their government and information provided on personal hygiene and safety. This includes washing hands thoroughly with water and soap rather than rely on hand soap. Trying to avoid contact with your eyes and mouth unless youve recently washed your hands. Taking vitamins to strengthen your immune system. Staying away from people and avoiding areas like grocery stores as long as possible are other good recommendations provided that people should follow.

People are not sure what to do because the information comes at them so quickly. Even doctors are not sure when their patient asks them if stem cell therapy is a safe option to prevent or treat the coronavirus. When I have doctors calling me just because they saw that I offer regenerative medicine information online, I knew it was time to start getting aggressive with these classes and offer my assistance to everyone.

For more information you can call our team at: 727-748-7389

About Dr. Bart Rademaker

Dr. Bart Rademaker is based in Tampa, Florida and has over 20 years of experience as a well-respected medical professional. He has affiliations with several hospitals including Morton Plant and Mease Countryside. His degree is from Erasmus University Rotterdam Faculty of Medicine and added regenerative medicine to his practice four years ago.

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BioIVT Opens New Blood Donor Center to Support Boston-area Research into COVID-19 Therapies, Vaccines and Diagnostics – PRNewswire

WESTBURY, N.Y., April 6, 2020 /PRNewswire/ --BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the opening of its new blood donor center on the Tufts University campus in Medford, MA to support academic and pharmaceutical researchers involved in COVID-19, cell and gene therapy research.

"BioIVT wants to play a leading role in supporting COVID-19 research efforts and blood donations are a vital resource for the research and development of new therapies, vaccines, and diagnostics. We have many years' experience developing blood products, including blood-derived immune cells for cell and gene therapy research, and we want to make that expertise count," said BioIVT CEO Jeff Gatz. "Researchers recognize and appreciate BioIVT's rapid response and commitment to high quality, fresh blood products and this new donor center will allow us to offer those attributes and services to additional US clients."

BioIVT's new Boston blood donor center is its seventh. The company has similar facilities located in California, Tennessee and Pennsylvania to serve US clients and in London, UK for EU-based clients.

"While the initial focus at our Boston donor center will be on delivering fresh blood, leukopaks and buffy coats within hours of collection, we plan to add more capabilities and donors over time," said Jeff Widdoss, Vice President of Donor Center Operations at BioIVT.

Leukopaks, which contain concentrated white blood cells, are used to help identify promising new drug candidates, assess toxicity levels, and conduct stem cell and gene therapy research. They are particularly useful for researchers who need to obtain large numbers of leukocytes from a single donor.

BioIVT blood products can be supplied with specific clinical data, such as the donor age, ethnicity, gender, BMI and smoking status. Its leukopaks are also human leukocyte antigen (HLA), FC receptor and cytomegalovirus typed. HLA typing is used to match patients and donors for bone marrow or cord blood transplants. FC receptors play an important role in antibody-dependent immune responses.

COVID-19-related Precautions Blood donor centers are considered essential businesses and will remain open during the COVID-19 quarantine. BioIVT is taking additional safety measures to protect both blood donors and its staff during this difficult time. It has instituted several social distancing measures, including increasing the space between chairs in the waiting room and between donor beds, and limiting the entrance of non-essential personnel. The screening rooms are disinfected between donors and all areas of the center continue to be cleaned at regular intervals.

As soon as each blood donor signs their informed consent form, their temperature is taken. If they have a fever, their appointment is postponed, and they are referred to their physician. Any donor who develops COVID-19 symptoms after donating blood is required to inform the center immediately.

All BioIVT blood collections are conducted under institutional review board (IRB) oversight and according to US Food and Drug Administration (FDA) regulations and American Association of Blood Banks (AABB) guidelines.

Those who would like to donate blood at BioIVT's new Boston-area donor center should call 1-833-GO-4-CURE or visit http://www.biospecialty.com to make an appointment.

Further information about the products available from BioIVT's new donor center can be found at https://info.bioivt.com/ma-donor-ctr-req.

About BioIVTBioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit http://www.bioivt.com or follow the company on Twitter @BioIVT.

BioIVT Contact: Courtney Noah, SVP, Marketing & Client Services, 516-483-1196Media Contact: Lisa Osborne, Rana Healthcare Solutions, 206-992-5245, [emailprotected]

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Stem Cell Assay Industry – Market Demand | Recent Trends and Developments Analys – News by aeresearch

Latest Report Stem Cell Assay Industry Market size |Industry Segment by Applications (Regenerative Medicine andClinical Research), by Type (Viability,Purification andIdentification), Regional Outlook, Market Demand, Latest Trends, Stem Cell Assay Industry Industry Share & Revenue by Manufacturers, Company Profiles, Growth Forecasts 2025. Analyze current market size and upcoming 5 years growth of this industry.

This detailed market study on Stem Cell Assay Industry market is a collection of the specifics related to the industry vertical. The evaluation has been considered from a dual perspective with respect to production as well as consumption.

Considering the production aspect, the report incorporates details regarding the product renumeration, manufacturing of the product along with the gross margins of the firms manufacturing the product. While speaking of consumption, the research includes data about the product consumption value and the product consumption volume. It also describes about the import as well as export of the products.

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