On Monday, it was announced thatNSW public schools will return to the classroom full time from next Monday, two months after COVID-19 restrictions forced around 800,000 children to study remotely.

Its a normal school week from next week and they need to be attending. Rolls will be marked as normal and unexplained absences will be followed up, NSW Education Minister Sarah Mitchell said on Tuesday.

However, many teachers are not pleased with how they discovered the return to full-time schooling, withNSW Teachers Federation president Angelo Gavrielatos saying the union had not been consulted before the governments decision.

He said teachers had already planned for the previously announced staggered return to school, with face-to-face learning gradually scaled up throughout term two.

This caused a lot of concern, frustration and anger among teachers and principals across the state. They turned themselves inside out not once, not twice, but repeatedly, trying to come to terms with this crisis, Gavrielatos told ABC television.

This is a pandemic that we find ourselves in thats what makes what happened last night even more important and more disrespectful.

Listen: The risk And reality of a COVID19 second wave in Australia. Post continues below audio.

Mamamiaspoke to five teachers about how they discovered the news of the return to full-time schooling, and how they feel about it. Heres what they had to say.

I went on Facebook last night and saw an article and was shocked! I checked my staff emails and there was no information. I messaged every other teacher I knew and no one had any idea except for seeing it on Facebook.

We all found this out through Facebook, except for those who dont seem to have social media, who found out when Gladys Berejeklian announced it this morning. The principals were not informed so they were unable to inform us!

There has still been no official communication from the department or our union. It was infuriating to find out on Facebook! But I dont blame any principals or teachers or the Department of Education, as they all found out at the same time as I did, in the same way. Which is disgusting!

I think its been a really hard time to navigate. I have been frustrated by the way weve been treated, but I dont blame anyone.

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'I found out on Facebook.' 5 teachers share how they feel about returning to school full-time. - Mamamia

Skin Stem Cells Comments Off on ‘I found out on Facebook.’ 5 teachers share how they feel about returning to school full-time. – Mamamia | May 21st, 2020

Latest Patent Further Strengthens Intellectual Property Portfolio Covering Novel Platform for Precisely Controlling Core Cell Migration Mechanisms

Decelerator Technology Has Key Potential Applications in Treatment of Cancer and Fibrosis and Serves as Key Complement to Companys Cell Motility Accelerator Platform for Enhanced Tissue Repair

NEW YORK, May 20, 2020 (GLOBE NEWSWIRE) -- MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced the issuance of a new European patent providing broad protection for the companys first-of-its-kind cell movement decelerator technology, which has potential therapeutic applications in combating cancer metastases and fibrosis. The companys decelerator technology is being developed alongside MicroCures accelerator technology, which is designed to enhance repair of tissue, nerves, and organs following trauma. With the newly issued patent in the European Union (#3052117), the companys global patent estate now includes eight issued and 12 pending patents covering its underlying technology, as well as the therapeutic programs that have emerged from the platform.

Our proprietary platform technology represents a fundamentally new way of thinking about how to harness the bodys natural cell movement processes to drive therapeutic outcomes in response to a range of medical challenges. Whether it is removing the brakes from cells to accelerate their migration and drive tissue, nerve and organ repair, or putting the brakes on cell movement to combat tumor metastases and fibrosis, we are pioneering an entirely new treatment paradigm, said Derek Proudian, co-founder and chief executive officer of MicroCures. While we clearly recognize the importance of the development work we are undertaking in support of this platform, it is equally important to build a strong, wide-reaching intellectual property portfolio to protect it. This latest patent issuance provides us yet another key piece of intellectual property, bringing our total number of issued and pending patents to 20.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins.

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. Additionally, the company is developing a decelerator technology based on the same foundational science. Instead of accelerating cell movement for therapeutic repair and regeneration, this technology is designed to slow or halt the movement of cells, potentially offering a unique, natural approach to preventing cancer metastases and fibrosis.

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to accelerate and improve recovery after traumatic injury. MicroCures has developed a first-of-its-kind therapeutic platform that precisely controls the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve repair/regeneration, spinal cord repair/regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued patents, as well as 12 pending patent applications.

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For more information please visit: http://www.microcures.com

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MicroCures Announces Issuance of New European Patent Providing Broad Protection for First-of-its-Kind Cell Movement Decelerator Technology - Yahoo...

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Aggressive public health measures tostem the tidal wave of coronavirus infections have left people isolated,unemployed and wondering when it will all end. Life probably wont gocompletely back to normal until vaccines against the virus are available,experts warn.

Researchers are working hard on thatfront. At least six vaccines are currently being tested in people, says EstherKrofah, chief executive of the FasterCures center at the Milken Institute in Washington,D.C. We expect about two dozen more toenter clinical trials by this summer and early fall. That is a huge number,Krofah said at an April 17 briefing. Dozens more are in earlier stages oftesting.

In unpublished, preliminary results of a test of one vaccine, inoculated people made as many antibodies against the coronavirus as people who have recovered from COVID-19 (SN: 5/18/20). The mRNA-based vaccine induces human cells to make one of the viruss proteins, which the immune system then builds antibodies to attack. That study was small, only eight people, but a second phase of safety testing has begun.

But vaccinestake time to test thoroughly (SN: 2/21/20). Even with acceleratedtimelines and talk of emergency use of promising vaccines for health care workersand others at high risk of catching the virus, the general public will likelywait a year or more to be vaccinated.

In the meantime, new treatments may helpsave lives or lessen the severity of disease in people who become ill.Researchers around the world are experimenting with more than 130 drugs to findout if any can help COVID-19 patients, according to atracker maintained by the Milken Institute.

Some of those drugs are aimed atstopping the virus, while others may help calm overactive immune responses thatdamage lungs and other organs. Although researchers are testing a battery ofrepurposed drugs and devising new ones, there is still a great deal ofuncertainty over whether the drugs help, or maybe even hurt.

The wait is frustrating, but theres still much doctors and scientists dont know about how this new coronavirus affects the body. Getting answers will take time, and finding measures to counter the virus that are both safe and effective will take even more. Early results suggest that the antiviral drug remdesivir can modestly speed recovery from COVID-19 (SN: 5/13/20). It is not a cure, but the drug may become the new standard of care as researchers continue to test other therapies.

Scientists and journalists share a core belief in questioning, observing and verifying to reach the truth. Science News reports on crucial research and discovery across science disciplines. We need your financial support to make it happen every contribution makes a difference.

Antiviral drugs interfere with a viruss ability to replicate itself, though such drugs are difficult to create. Remdesivir is being tested in half a dozen clinical trials worldwide. The drug mimics a building block of RNA, the genetic material of the coronavirus (SN: 3/10/20). When the virus copies its RNA, remdesivir replaces some of the building blocks, preventing new virus copies from being produced, laboratory studies have shown.

Early results in COVID-19 patients given the drug outside of a clinical trial showed that 68 percent needed less oxygen support after treatment, as reported online April 10 in the New England Journal of Medicine (SN: 4/29/20). The drug went to very sick patients, including those who needed oxygen from a ventilator or through tubes in the nose. Other researchers have disputed those results, questioning the study methods and statistical analyses, which may have given an exaggerated impression of good outcomes. The studys authors say they have reanalyzed the data and still conclude that remdesivir has benefits.

Soon after, the U.S. National Instituteof Allergy and Infectious Diseases announced that hospitalized patients withCOVID-19 who got intravenous remdesivir recoveredmore quickly than those on a placebo: in 11 days versus 15. Those findingshad not been reviewed by other scientists at the time of the announcement. Thedug provides researchers with a baseline for comparing other treatments. Wethink its really opening the door to the fact that we now have the capabilityof treating, Anthony Fauci, director of the NIAID said April 29 in a newsbriefing at the White House.

Antiviral medications used against HIV are also being tested against COVID-19. The combination of lopinavir and ritonavir stops an HIV enzyme called the M protease from cutting viral proteins so that the virus can replicate itself. The SARS-CoV-2 virus produces a similar enzyme. But early results from a small study in China showed that the combination didnt stop viral replication or improve symptoms (SN: 3/19/20), and there were side effects.

For now, the Society of Critical CareMedicine recommendsagainst using the drugs, and the Infectious Diseases Society of Americasays patients should get the drugs onlyas part of a clinical trial. Several large trials may report results soon.

The HIV drugs may not work well against SARS-CoV-2, even though the viruses have similar M proteases: The coronaviruss enzyme lacks a pocket where the drugs fit in the HIV version of the enzyme.

This illustrates why antiviral drugs areso difficult to develop. Designing a drug requires knowing the 3-D structure ofthe viruss proteins, which can take months to years. But researchers arealready getting some close-up views of the new coronavirus. A team in Chinaexamined the structure of the coronaviruss M protease and designed smallmolecules that could block a part of the protein necessary to do its job. Theteam describedtwo such molecules, dubbed 11a and 11b, April 22 in Science.

In test tubes, both molecules stopped the virus from replicating in monkey cells. In mice, 11a stuck around longer in the blood than 11b, so the researchers tested 11a further and found it seemed safe in rats and beagles. More animal tests will probably be needed to show whether it stops the virus, then multiple stages of human tests will have to follow. The drug development and testing process often takes on average 10 years or more, and can fail at any point along the way.

Meanwhile, hundreds of thousands of people worldwide have already recovered from COVID-19, and many are donating blood that might contain virus-fighting antibodies. Clinical trials are under way to test whether antibodies from recovered patients blood plasma can help people fight off the virus (SN: 4/25/20, p. 6). More such trials are planned.

Stopping the virus is only half the problem. In some people seriously ill with COVID-19, their immune system becomes the enemy, unleashing storms of immune chemicals called cytokines. Those cytokines trigger immune cells to join the fight against the virus, but sometimes the cells go too far, causing damaging inflammation.

Some of the drugs used to calm cytokines in cancer patients (SN: 6/27/18, p. 22) may also help people with COVID-19 ride out the storm, says cancer researcher Lee Greenberger, chief scientific officer of Leukemia and Lymphoma Society. Several of those drugs are being tested against the coronavirus now.

Hydroxychloroquine, a drug approved totreat autoimmune disorders such as lupus and rheumatoid arthritis, became ahousehold word after President Trump touted it as a possible COVID-19treatment.

The drug is being tested in numerouslarge clinical trials around the world to see if it might help calm cytokinestorms in COVID-19 patients as well. But so far, there is no solid evidence thatit works either to prevent infection in people or to treat people who alreadyhave the disease.

And in some studies the drug has caused serious side effects, including causing irregular heartbeats, says Raymond Woosley, a pharmacologist at the University of Arizona College of Medicine in Phoenix. People with heart problems, low potassium or low oxygen levels in their blood are at higher risk of these side effects, he says. And those are exactly the kinds of patients who are most vulnerable to COVID-19. So, the very sickest COVID patients are those at most risk for these life-threatening arrhythmias and cardiac effects.

Results of some rigorous clinical trialsof hydroxychloroquine are expected this summer. Meanwhile, the U.S. Food andDrug Administration allows the drug to be used when no other treatment isavailable and patients cant join a clinical trial.

Todays enthusiasm for any drug thatseems promising feels familiar, says Woosley. He remembers the excitement overAZT, the first drug used to fight HIV in the 1980s. It wasnt the best drug tocombat the AIDS epidemic, and better ones came later. Likewise, the firsttreatments for COVID-19 might be better than nothing, but not the best we willultimately get.

Meanwhile, we wait.

With hundreds of clinical trials going on around the world, some answers may come soon. But for now, keeping the coronavirus contained will probably require aggressive testing, tracing and isolating contacts of people who have the virus and continued social distancing.

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As we wait for a vaccine, heres a snapshot of potential COVID-19 treatments - Science News

Cardiac Stem Cells Comments Off on As we wait for a vaccine, heres a snapshot of potential COVID-19 treatments – Science News | May 21st, 2020

Coronavirus and Mesenchymal Stem Cells

Therapy for Pneumonia Patients infected by 2019 Novel Coronavirus

Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)

Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus

On the website of the Harvard Stem Cell Institute you will find the following news release about the ongoing clinical trial conducted by our daughter company RHEACELLin patients suffering from limbal stem cell deficiency: Restoring vision: A stem cell therapy for cornea regeneration reaches the clinical-trial stage.

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and several European competent national regulatory authorities. The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) for the treatment of EB.

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the German regulatory authority (Paul Ehrlich Institute). The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of LSCD.

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).

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TICEBA >< Advantages of Skin Stem Cells

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New treatment for baldness has shown its effectiveness: for its realization has been applied proteins derived from stem cells of adipose tissue means. The experiment was carried out by scientists from South Korea.

The scientific staff of the Busan University as part of the experience tested the ability to cure the most familiar type of baldness androgenic alopecia, utilizing extract of stem cells of adipose tissue. This disease can not be attributed to the most hazardous to health, but it negatively affects the psychological status and life of the people. Highest quality drugs against the disease have side effects, including erectile dysfunction, therefore physicians continue to look for safe assets.

For the experiment, scientists from South Korea has invited nine women and 29 men of middle age who had suffered from androgenic alopecia. They were divided into two groups, representatives of one of them they rubbed my skin with the extract of stem cells, and the second placebo. Four months later, the experience of those volunteers, to whom was applied the protein to stem cells, the researchers found a significant increase in hair volume and diameter of follicles. Next, the researchers intend to perform a similar experiment with a larger number of respondents from different population groups.

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In South Korea the problem of hair loss solved with the help of stem cells of adipose tissue - The Times Hub

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Image: A scanning electron microscope image of SARS-CoV-2 (Photo courtesy of NIAID-RML)

The drug, interferon-lambda, is a manufactured form of a naturally occurring protein that has been given in previous clinical trials to more than 3,000 people infected with hepatitis viruses. Results in laboratory settings and in animals also suggest that lambda-interferon may be helpful in controlling viruses that cause respiratory illnesses such as influenza and SARS, an often fatal disease, as well as help snuff out other common viral infections. Interferon-lambda orchestrates the bodys natural defenses against infection by issuing a call in the troops order to constituent cells of the immune system. Receptors for interferon-lambda are restricted to the linings of the lungs, intestine and liver, thus producing fewer side effects.

The clinical trial is underway at Stanford Medicine will determine whether the drug can keep people who have just tested positive for the coronavirus out of the hospital, help them recover faster and make them safer to be around in the meantime. The researchers will also investigate whether the drug stems viral shedding, which would reduce transmission to family members and the community. The investigators are recruiting 120 participants who have just been diagnosed with cases of mild COVID-19 at Stanford Health Care and other local hospitals, emergency rooms, clinics and drive-through testing sites. Trial participants, randomly sorted into two groups, will be given single injections under the skin of either a placebo or interferon-lambda. Then they will be monitored for 28 days for symptoms, disease severity, rates of hospitalization, and duration and quantity of viral shedding.

Even though these individuals may not need hospitalization, infection with COVID-19 results in respiratory symptoms and lost productivity, said Upinder Singh, MD, professor of infectious diseases and of microbiology and immunology at the school, who is co-leading the study. Plus and this is important patients with mild disease contribute to community disease transmission. Limiting viral shedding from this group would reduce transmission to family members and others, which is crucial to controlling epidemic disease spread.

Related Links:Stanford Medicine

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Stanford Researchers Investigate New Drug that Can Treat Mild COVID-19 Cases and Stem Viral Shedding - HospiMedica

Skin Stem Cells Comments Off on Stanford Researchers Investigate New Drug that Can Treat Mild COVID-19 Cases and Stem Viral Shedding – HospiMedica | May 19th, 2020

I didnt have any mum friends to give me the heads up on this a few years ago, and I vowed to never let someone else walk into that battlefield unprepared.

I know poo talk isnt very graceful, but knowledge is power, and absolutely no one had given me the much-needed secret poo power prep talk.

So, heres yours, with all the learnings that made my second time around much more bearable.

LISTEN: We take a look at the final month of pregnancy, including what to pack in your hospital bag. Post continues after audio.

Soften those bad boys up with stool softeners. If you ignore them, theyll go away only works for door-knockers. The longer you leave these guys, the harder theyll knock. With each passing day, your poo will join forces and create a solid army. A rock-solid army of pain.

Pushing can be a scary feeling. Everything down there is vulnerable, and I was worried I might give birth to my entire uterus mid poo. I didnt (phew). I found the stool softeners helped with this and I didnt need to use so much scary force the second time round.

So to sum it up? Prunes and prune juice are your friends, drink loads of water, and dont be afraid to ask for laxatives if you need them.

Hold your fragile stitched (or unstitched) front if that makes you feel more comfortable and secure. It may still be an uncomfortable experience, but it doesnt have to feel like the ass apocalypse I experienced. NO ONE PREPARED ME FOR IT.

Dont be scared though, Id still do it all again for my kids. Just be prepared so you can crap like a queen on the porcelain throne.

If you didnt struggle with a post-birth poo, I have only one question How does it feel to be one of Gods favourites?

This post originially appeared on Living My Family Life and has been edited and republished with full permission.

Katie Bowman is a mum to a 4-year-old girl and two-year-old twin girls. A part-time hairdresser, she spends her time blogging about her days of chaos on her Facebook page,Living My Family Life.

Feature Image: Supplied.

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'I need to talk about the 'third birth' no one prepares you for: The post-baby poo.' - Mamamia

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Global Cell Therapy Technologies Marketwas valued US$ 12 billion in 2018 and is expected to reach US$ 35 billion by 2026, at CAGR of 12.14 %during forecast period.

The objective of the report is to present comprehensive assessment projections with a suitable set of assumptions and methodology. The report helps in understanding Global Cell Therapy Technologies Market dynamics, structure by identifying and analyzing the market segments and projecting the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, growth strategies, and regional presence. To understand the market dynamics and by region, the report has covered the PEST analysis by region and key economies across the globe, which are supposed to have an impact on market in forecast period. PORTERs analysis, and SVOR analysis of the market as well as detailed SWOT analysis of key players has been done to analyze their strategies. The report will to address all questions of shareholders to prioritize the efforts and investment in the near future to the emerging segment in the Global Cell Therapy Technologies Market.

REQUEST FOR FREE SAMPLE REPORT:https://www.maximizemarketresearch.com/request-sample//31531/

The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

Global Cell Therapy Technologies Market: Overview

Cell therapy is a transplantation of live human cells to replace or repair damaged tissue and/or cells. With the help of new technologies, limitless imagination, and innovative products, many different types of cells may be used as part of a therapy or treatment for different types of diseases and conditions. Celltherapy technologies plays key role in the practice of medicine such as old fashioned bone marrow transplants is replaced by Hematopoietic stem cell transplantation, capacity of cells in drug discovery. Cell therapy overlap with different therapies like, gene therapy, tissue engineering, cancer vaccines, regenerative medicine, and drug delivery. Establishment of cell banking facilities and production, storage, and characterization of cells are increasing volumetric capabilities of the cell therapy market globally. Initiation of constructive guidelines for cell therapy manufacturing and proven effectiveness of products, these are primary growth stimulants of the market.

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Global Cell Therapy Technologies Market: Drivers and Restraints

The growth of cell therapy technologies market is highly driven by, increasing demand for clinical trials on oncology-oriented cell-based therapy, demand for advanced cell therapy instruments is increasing, owing to its affordability and sustainability, government and private organization , investing more funds in cell-based research therapy for life-style diseases such as diabetes, decrease in prices of stem cell therapies are leading to increased tendency of buyers towards cell therapy, existing companies are collaborating with research institute in order to best fit into regulatory model for cell therapies.Moreover, Healthcare practitioners uses stem cells obtained from bone marrow or blood for treatment of patients with cancer, blood disorders, and immune-related disorders and Development in cell banking facilities and resultant expansion of production, storage, and characterization of cells, these factors will drive the market of cell therapy technologies during forecast period.

On the other hand, the high cost of cell-based research and some ethical issue & legally controversial, are expected to hamper market growth of Cell Therapy Technologies during the forecast period

AJune 2016, there were around 351 companies across the U.S. that were engaged in advertising unauthorized stem cell treatments at their clinics. Such clinics boosted the revenue in this market.in August 2017, the U.S. FDA announced increased enforcement of regulations and oversight of clinics involved in practicing unapproved stem cell therapies. This might hamper the revenue generation during the forecast period; nevertheless, it will allow safe and effective use of stem cell therapies.

Global Cell Therapy Technologies Market: Segmentation Analysis

On the basis of product, the consumables segment had largest market share in 2018 and is expected to drive the cell therapy instruments market during forecast period at XX % CAGR owing to the huge demand for consumables in cell-based experiments and cancer research and increasing number of new product launches and consumables are essential for every step of cell processing. This is further expected to drive their adoption in the market. These factors will boost the market of Cell Therapy Technologies Market in upcoming years.

On the basis of process, the cell processing had largest market share in 2018 and is expected to grow at the highest CAGR during the forecast period owing to in cell processing stage,a use of cell therapy instruments and media at highest rate, mainly in culture media processing. This is a major factor will drive the market share during forecast period.

Global Cell Therapy Technologies Market: Regional Analysis

North America to held largest market share of the cell therapy technologies in 2018 and expected to grow at highest CAGR during forecast period owing to increasing R&D programs in the pharmaceutical and biotechnology industries. North America followed by Europe, Asia Pacific and Rest of the world (Row).Scope of Global Cell Therapy Technologies Market

Global Cell Therapy Technologies Market, by Product

Consumables Equipment Systems & SoftwareGlobal Cell Therapy Technologies Market, by Cell Type

Human Cells Animal CellsGlobal Cell Therapy Technologies Market, by Process Stages

Cell Processing Cell Preservation, Distribution, and Handling Process Monitoring and Quality ControlGlobal Cell Therapy Technologies Market, by End Users

Life Science Research Companies Research InstitutesGlobal Cell Therapy Technologies Market, by Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Therapy Technologies Market

Beckman Coulter, Inc. Becton Dickinson and Company GE Healthcare Lonza Merck KGaA MiltenyiBiotec STEMCELL Technologies, Inc. Terumo BCT, Inc. Thermo Fisher Scientific, Inc. Sartorius AG

MAJOR TOC OF THE REPORT

Chapter One: Cell Therapy Technologies Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Therapy Technologies Market Competition, by Players

Chapter Four: Global Cell Therapy Technologies Market Size by Regions

Chapter Five: North America Cell Therapy Technologies Revenue by Countries

Chapter Six: Europe Cell Therapy Technologies Revenue by Countries

Chapter Seven: Asia-Pacific Cell Therapy Technologies Revenue by Countries

Chapter Eight: South America Cell Therapy Technologies Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Therapy Technologies by Countries

Chapter Ten: Global Cell Therapy Technologies Market Segment by Type

Chapter Eleven: Global Cell Therapy Technologies Market Segment by Application

Chapter Twelve: Global Cell Therapy Technologies Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Cell Therapy Technologies Market Report at:https://www.maximizemarketresearch.com/market-report/global-cell-therapy-technologies-market/31531/

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Global Cell Therapy Technologies Market : Industry Analysis and Forecast... - Azizsalon News

Bone Marrow Stem Cells Comments Off on Global Cell Therapy Technologies Market : Industry Analysis and Forecast… – Azizsalon News | May 19th, 2020

MINNEAPOLIS & EL SEGUNDO, Calif.--(BUSINESS WIRE)--Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and NantKwest (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of the immune system using natural killer (NK) cells to treat cancer and infectious diseases, today announced an agreement through which Be The Match BioTherapies is providing donor material for a NantKwest Phase 1b clinical trial to address acute respiratory distress syndrome (ARDS), one of the primary causes of COVID-19 deaths.

The agreement combines Be The Match BioTherapies ability to provide high-quality cellular source material from the worlds largest registry of volunteer donors with NantKwests capabilities in manufacturing off-the-shelf cell therapies. NantKwests allogeneic cell therapy is derived from human bone marrow and designed to treat the ARDS that results from severe COVID-19 cases. The therapy, called BM-Allo.MSC, uses mesenchymal stem cells (MSCs), multipotent progenitor cells known to have immunomodulatory properties, to reduce the lung inflammation associated with ARDS. Similar work in Europe with allogeneic MSC products in patients with COVID-19 and ARDS has demonstrated safety and efficacy in reducing inflammatory processes.

NantKwest recently announced FDA authorization of its investigational new drug (IND) application for BM-Allo.MSC and is moving rapidly to initiate a Phase 1b trial in patients with severe COVID-19. To expedite trial initiation, Be The Match BioTherapies is providing cryopreserved donor stem cell material from the Be The Match BioBank, a program of the National Marrow Donor Program/Be The Match. The accelerated access to material, combined with NantKwests scalable manufacturing processes, will allow for rapid distribution of BM-Allo.MSC to patients in need.

There is an immediate need for COVID-19 therapies across all stages of the disease, including for patients with ARDS, which is one of the most critical conditions caused by COVID-19, said Patrick Soon-Shiong, MD, Chairman and Chief Executive Officer of NantKwest. Thanks to the quality source material provided by Be The Match BioTherapies, we are prepared to rapidly scale manufacturing of this much-needed therapy, potentially saving numerous patients lives.

Through our teams unparalleled ability to identify, source and deliver high-quality donor material we have the opportunity to support the advancement of a cell therapy with potential to change the world. We are proud to partner with NantKwest to support our mission to save lives through cellular therapy and continue to make a difference for critically ill patients around the globe, said Chris McClain, Senior Vice President, Sales and New Business Development at Be The Match BioTherapies.

About Be The Match BioTherapies

Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program (NMDP)/Be The Match, and a research partnership with the CIBMTR (Center for International Blood and Marrow Transplant Research), the organization designs solutions that advance the development of cell and gene therapies across the globe.

Be The Match BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the Be The Match Registry, the worlds largest and most diverse registry of more than 22 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection and transplant centers worldwide, the organization develops, onboards, trains and manages expansive collection networks to advance cell therapies. Be The Match BioTherapies uses proven infrastructure consisting of regulatory compliance and managed logistics experts, as well as cell therapy supply chain case managers to successfully transport and deliver regulatory compliant life-saving therapies across the globe. Through the CIBMTR, Be The Match BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

For more information, visit http://www.BeTheMatchBioTherapies.com or follow Be The Match BioTherapies on LinkedIn or Twitter at @BTMBioTherapies.

About NantKwest

NantKwest (Nasdaq: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com.

Excerpt from:
Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths - Business Wire

Bone Marrow Stem Cells Comments Off on Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths – Business Wire | May 19th, 2020

The study is anticipated to consist of approximately thirty patients with potential involvement of the NIH of Mexico in other CytoDyn trials

VANCOUVER, Washington, May 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be coordinating with the NIH of Mexico and providing leronlimab for a trial for the severe/critical COVID-19 population in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn is also enrolling a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population later in the week.

We look forward to evaluating leronlimab as a treatment option for patients of COVID-19. We have seen the devastation of this disease on the citizens of Mexico and are looking forward to providing effective treatment options to mitigate the devastation of COVID-19, said Dr. Gustavo Reyes Tern, head of the Coordinating Commission of National Institutes of Health and High Specialty Hospitals of Mexico, an organization that coordinates the main institutions of medical care and public research in the country.

The NIH of Mexico is committed to help alleviate human suffering and mortality of Mexican citizens. The Metropolitan Area of the Valley of Mexico has a population of approximately 21.5 million people and the contagious nature of COVID-19 is relentless. We look forward to working with the NIH of Mexico to rapidly commence with the proposed study. We also believe that this study results, along with the ongoing Phase 2 study, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19...

Bone Marrow Stem Cells Comments Off on CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19… | May 19th, 2020

Despite many breakthroughs in cardiovascular treatment, heart attacks and heart failure still pose a very large threat to the American population. The largest challenge in patients who have had a cardiac complication is the restoration of function to the damaged heart. Since damaged heart tissue is very difficult for the body to replace, physicians are continually looking for new methods of treating the heart.

Regenerative treatment through the use of stem cells is showing a large amount of potential at not only helping reverse the resulting damage of a cardiac attack, but in actually re-growing the damaged tissue in order to restore function.

To understand what stem cells can potentially do for the heart, it is important to first understand the different heart cells that can be damaged in a cardiac event. Destruction of the heart muscle cells, called cardiomyocytes, is the primary cause behind loss of function in a damaged heart. These cells are the muscle behind heart contraction, which sends blood to the rest of the body.

Secondly, vascular endothelial cells (inner lining of blood vessels) and smooth muscle cells (outer lining of blood vessels) each play an important role in the formation of new arteries. These serve to draw nutrients and oxygen to the remaining cardiomyocytes following heart damage, directly influencing the capabilities of a damaged heart.

Numerous studies are being conducted into the purposing of stem cells this manner, with one study providing evidence that bone marrow stem cells were able to develop into the required myocardial cells in mice. The ability to develop human hematopoietic stem cells for heart muscle is already documented technique, with the method of application into humans and the results of implantation still under study.

The research currently being performed on stem cells for cardiac treatment is focused on developing known stem cell traits into a working cure for cardiac complications. The current hurdles researchers face include how to best expand stem cells injected into the heart, how to best deliver the cells, and how to discover new niches (groupings) of stem cells in the body.

Delivery: Current methods of delivery include generic IV injection, which is minimally invasive with varying degrees of success. The most dependable method is to have direct injection into the heart, which requires surgery for visualization. Complications may include potentially clogging the arteries with the introduced stem cells and the invasiveness of the surgery.

Expanding Stem Cells: The majority of transplanted stem cells fail to reach the area of damage. It is crucial for a physician to be able to accurately deliver a large amount of stem cells to offer the patient the best treatment. Methods of better stem cell isolation, identification, and expansion into tissue are currently being developed.

Physician First Choice offers stem cell therapy for cardiac disease. The clinic has multiple stem cell doctors with extensive experience in stem cell therapy for numerous conditions. The stem cell clinic sees patients from all over California and the country, providing both IV stem cell therapy and injections into arthritic joints and areas with tendonitis and ligament injury.

Call (888) 988-0515 for more information and scheduling today!

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cardiac disease and stem cells | Stem Cell Treatment in ...

Cardiac Stem Cells Comments Off on cardiac disease and stem cells | Stem Cell Treatment in … | May 18th, 2020

Coronavirus health scams are rampant, with businesses taking advantage of peoples fears to sell all sorts of unproven products for the prevention and treatment of COVID-19. Some of these snake oil cures are innocuous, such as elderberry juice, but others can be harmful, such as colloidal silver.

Among the products with considerable potential for harm are unproven stem cell therapies. Unfortunately, the emergence of this particular line of sham COVID-19 treatments isnt all that surprising. For more than a decade, businesses have been aggressively pitching unsubstantiated and unlicensed stem cell products to vulnerable and often desperate individuals with illnesses or injuries for which no known treatment exists, such as Alzheimers disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD) and spinal cord injuries. The results have sometimes been deadly.

There are some medical conditions for which stem cell therapies have been shown to be safe and effective, but they are few in number mostly cancer and several blood and immune disorders.

Leigh Turner, a bioethicist at the University of Minnesota, has been investigating the direct-to-consumer marketing of spurious stem cell therapies and related exosome products in the United States for nearly a decade. In an article published recently in the journal Cell Stem Cell, Leigh describes the latest twist in this cynical saga: how some stem cell businesses are seizing the [COVID-19] pandemic as an opportunity to profit from hope and desperation.

MinnPost spoke with Turner late last week about what he found when researching that paper. The following is an edited transcript of the interview.

MinnPost: Companies seem to be using the same kind of marketing strategies to sell unproven stem cell therapies for COVID-19 as they have for other medical conditions.

Leigh Turner: Yes. These are opportunistic businesses. They look for marketplace opportunities, ways to generate e-revenue streams. And the COVID-19 pandemic is another business opportunity. Its not like theyve pivoted away from what they did in the past. If they were marketing stem cell treatments for Parkinsons disease, or ALS or spinal injuries, they havent stopped doing that. Theyve just added that theyve now got a stem cell treatment or an exosome therapy to treat or prevent COVID-19.

MP: They seem to be marketing their products primary as immune system boosters.

Leigh Turner

MP: At least one company is telling people that they should bank their stem cells to use as a treament if they get infected with the coronavirus.

LT: There are several business models at play right now. One is, come on in and get your stem cell immune booster to reduce your chances of getting COVID-19. They may also claim it will reduce your symptoms should you get it. Another marketing pitch is a bit more cautious. It says that if you come in now when youre in good health, they will bank your cells. Youll pay for the initial extraction of cells and also monthly or yearly for banking. The company then claims that should you fall ill with COVID-19 down the road, youll have those healthy cells available for you to use. Of course, they dont offer a lot of detail about how the cells would actually help you. You just supposed to take it for granted that they will.

MP: Theres no evidence of that.

LT: No. Its all just pseudoscience. But there is a meaningful hypothesis behind it. Thats how these businesses operate by fusing science with pseudoscience, credible research with junk claims.

MP: What is that hypothesis?

LT: There are companies and academic institutions right now that are interested in testing stem cell products, but not as immune boosters, not to prevent COVID-19 and not to eliminate the virus if someone gets infected. The studies right now are focusing on a very particular population of people with COVID-19 those who are typically in ICUs, suffering from acute respiratory distress syndrome. The hypothesis is that if certain types of stem cell products are administered to those people, we may be able to reduce inflammation in the lungs and help shorten the illness. But its a hypothesis.

MP: A good one?

LT: Its not an outrageous hypothesis. If you look at the existing literature, there have been studies done in the past that used stem cells for lung and respiratory disease. So far, those studies suggest that if you use clinical-grade stem cells and if you do it in a very rigorous way the safety profile is pretty good. But none of those studies has established extensive evidence of efficacy yet. Ideally, what you want is carefully designed, carefully conducted clinical trials testing that hypothesis and generating that evidence. These businesses the ones marketing stem cell therapies directly to individuals are not part of that scientific world.

MP: How do those businesses pull their customers in? How do they find them?

LT: They are typically big on social media. Im talking generally here, but they have Twitter accounts. They have YouTube channels. They have a Facebook page. Theyre not just putting up a website and hoping that somebody walks in the door. They hire social media marketing companies. They use marketing firms. They have pretty sophisticated marketing strategies that are tailored to particular demographics. It may be that they are targeting an elderly population, for example, because if youre interested in reaching people with COPD, youre not going to be trying to find 18-year-olds. Some businesses here in Minneapolis and elsewhere will have what they describe as educational seminars, which are basically infomercials. They are marketing events. They will try to get people to come to a convention center, a hotel [conference] room or a restaurant. Everything is free, but what theyll do is use hard-sell sales tactics to get people to commit, to write a check. Often theyll tell people that if they sign on today, theyll knock $2,000 or so off the price. But, of course, theyre not holding these events right now. They cant have these public gatherings.

MP: So, how are they selling people these products now, during the pandemic?

LT: More of it is happening online. One company, for example, uses a graduated pricing model. If its one person, its one price point. If its you and a family member, you both get a break on the procedure. And if its you and two additional family members, the price goes down even more. They use these things to try to get people to come in the door. One company in California has adapted to the pandemic in a different way. They have a do-it-yourself model. You dont have to even come into the clinic. You can buy their kit, and they ship it to your home. You then do the procedure at your dining room table.

MP: These stem cell products and treatments are quite expensive.

LT: Yes, some of the businesses Ive look at charge tens of thousands of dollars, although thats not necessarily for treating COVID-19. For COVID-19, it appears to be in the thousands-of-dollars category. In some cases, we dont know. The businesses can be pretty cagey. In some cases, they try to size up the customer and figure out how much they can extract from that person.

MP: Government agencies are cracking down on some of these stem cell businesses.

LT: The FDA (Food and Drug Administration), FTC (Federal Trade Commission) and Department of Justice have said that theyre going to be aggressive with dealing with these scams. And they have. Some businesses have already received letters from the regulators. That may be having a deterrent effect during the pandemic. Some businesses may want to jump in, but are afraid to do so. They may be waiting to see what happens before they take the chance.

MP: But the regulatory agencies are obviously not finding all of the businesses marketing unproven COVID-19 therapies.

LT: There is a lot of marketing fraud. And sometimes its quite challenging to figure out whats going on. Some of the clinics that I looked at didnt say, Were offering an immune booster for COVID-19. It was more just chatter. Clinics would put up a seven-minute video from one of their doctors about COVID-19 and emerging stem-cell research coming out of China, saying it was really encouraging. Then they would say, If you have any questions about stem cells and COVID-19, give us a call. So, whats the takeaway when a business does that? Does that mean they are selling stem cell treatments for COVID-19? Or are they just trying to get people to call? Its hard to know whats happening. If I had to guess, I say its a workaround. The businesses dont want to put it on their website, because thats too easy for someone from the FTC or the FDA to find. If they just put up a video, they can say theyre not marketing anything, that it was just meant to be educational.

MP: These businesses seem to rely on anecdotal cases or really small studies from China to support their claims.

LT: They use China in a couple of different ways. There was a case report, for example, that was published as a preprint. It wasnt published by a journal. It hasnt gone through peer review. It was just a preprint that someone put online. Its the case of a single individual with COVID-19 who received stem cells. Thats been written up in a very hyperbolic way, when really, its just a case report. Its one person. Some people get COVID-19 and recover anyway. You cant draw any conclusions from it about stem cells being efficacious, but its been written up that way. There was another study, very preliminary research, in which mesenchymal stem cells were administered to seven individuals with COVID-19 with various degrees of severity. A placebo was given to three individuals. The article doesnt provide the source of the stem cells. Nor does it provide much insight about the individuals who were given placebos, although they appear to be about 10 years older than [those receiving the stem cells]. It raises some interesting questions. It provides a basis for further research. But, unfortunately, some of the news media reports have been hyperbolic. Stem cell businesses use both these papers when marketing directly to consumers. They refer to these studies, and they also attach themselves to the bubbly media coverage.

MP: Consumers need to know that these products can be dangerous.

LT: Yes. The danger comes in several forms. Part of it is that these are financial scams lifting money off people who are worried and anxious. But, also, giving someone a product that hasnt been carefully tested in well-designed clinical trials raises a lot of concerns. Some businesses have released contaminated stem cell products into the marketplace. People end up getting infections and having to be hospitalized. It can be a very serious thing. Theres also the possibility that the wrong type of cell goes to the wrong part of the body and causes harm. When a company claims, for example, that a stem cell product will regenerate lung tissue and be an immune booster, one thing I would worry about is pulmonary embolisms. If someone is being given something that hasnt been thoroughly tested, its hard to know what would go wrong, but its easy to know something could go wrong.

FMI: Youll find the article on Cell Stem Cells website.

View original post here:
Unproven stem cell products are being peddled as COVID-19 'therapies,' U of M researcher reports - MinnPost

Spinal Cord Stem Cells Comments Off on Unproven stem cell products are being peddled as COVID-19 ‘therapies,’ U of M researcher reports – MinnPost | May 18th, 2020

This story appeared in the June 2020 issue as "Out of His Mind."Subscribeto Discover magazine for more stories like this.

It isnt every day that writer Philip Ball is asked to contribute to scientific experiments typically, hes reporting on them instead. But in 2015, scientists from a London-based project called Created Out of Mind asked Ball and a few other creatives if theyd participate in their work and then reflect on the experience. He agreed.

Ball first gave a sample, made up of cells from his skin, which was reprogrammed into stem cells that were subsequently grown into a brain organoid or, as the research team called it, a miniature brain in a dish. These futuristic-sounding specimens arent literal brains, and they dont look it, either. The round, cream-colored clusters of neurons simply resemble little blobs. Theyre not conscious. But they can be studied to better understand brain development such as where and when certain proteins misfold, which can signal whether a person will develop dementia.

This stained microscope image shows cells growing in a cross-section of a brain organoid, with neurons visible in red. (Credit: Chris Lovejoy and Selina Wray)

The researchers then asked Ball to reflect on his experience through writing. What started as a few blogs for Created Out of Mind eventually bloomed into a book, How to Grow a Human. Here, Ball recounts his time spent with his mini brain, and how the process gave him new insight into the future of lab-grown life.

Id pop into the lab from time to time and see how things were going. At one point, I stopped by and one of the researchers told me that the organoids werent looking great for some reason, they werent growing as they thought they might. We werent sure quite how they were going to turn out, and in the end many of them died before they could fully form.

Philip Ball (Credit: Richard Houghton)

But one day, out of the blue, one of the project leaders dropped me an email with photos and said, Look, heres your mini brain. And there it was ... I wish there was some drama to it, but the researchers were pretty casual about it because they grow these things all the time. And I wish I could say that I remember thinking, Oh my God, this is my second brain, but I think I was more relieved than anything that it actually grew into an organoid. The fact that they actually got one that had these really clear, discernible structures in it was pretty remarkable. If anything, I felt a little bit proud of myself that we actually created something in the end.

For me, one of the really interesting things I gleaned from the project was that the stuff we are made from is incredibly versatile. The technology of transforming cells from virtually any other tissue in the body is relatively new, and its leading to all sorts of directions in medicine and research. I was fascinated to see firsthand what extraordinary things cells even mature, adult cells are capable of.

See more here:
What It's Like to Grow a 'Mini-Brain' From Your Own Cells - Discover Magazine

Skin Stem Cells Comments Off on What It’s Like to Grow a ‘Mini-Brain’ From Your Own Cells – Discover Magazine | May 18th, 2020

18 May 2020

New research, in HIV positive patients being treated for blood cancer, has identified a critical time window after donor stem cell transplantation, during which the expanding donor cells are particularly vulnerable to being infected with HIV.

Patients with HIV who develop blood cancer may require treatment by allogeneic stem cell transplant, using bone marrow stem cells provided by a healthy donor. During a transplant, most of the patient's original immune cells are destroyed, and the immune system and blood cells are restored from the new donor stem cells.

'These results show a weak point that may explain why allogeneic stem cell transplants may not completely remove the virus from the body, despite a drastic reduction in the number of infected cells' saidsenior authorDr Julian Schulze zur Wiesch from the German Centre for Infection Research.

Stem cell transplantation in HIV positive patients has been the only medical intervention found to cure HIV (see BioNews 1039), however in nearly all cases HIV infection persists after transplantation.

In a new study it was discovered that immune cells generated from the donor stem cells are at risk of being infected with HIV during the first few weeks after transplantation.

In this study of 16 HIV positive participants with blood cancer, the researchers show that stem cell transplantation promotes reactivation of the virus within the patient's remaining original immune cells. This leads to some of the new immune cells becoming infected, thus 're-seeding' HIV within the host.

'Additional immunotherapy orgene therapy may be required to achieve ongoing, spontaneous control of HIV infection in people with HIV after allogeneic stem cell transplantation,' said Dr Schulze zur Wiesch.

This research was published in Science Translational Medicine.

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Critical window for re-infection with HIV after stem cell transplantation - BioNews

Bone Marrow Stem Cells Comments Off on Critical window for re-infection with HIV after stem cell transplantation – BioNews | May 18th, 2020

EL SEGUNDO, Calif.--(BUSINESS WIRE)--NantKwest, Inc. (NASDAQ: NK) today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow. NantKwest has entered into an agreement with the National Marrow Donor Program (Be the Match) to provide donor material and has developed automated proprietary methods to expand and generate multiple dose forms utilizing a modular, closed system (GMP-in-a-box) from NantKwest affiliate ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.

There is an urgent need to develop broadly accessible treatment options for the devastating outcomes seen in the thousands of COVID-19 patients who are facing severe disease with ARDS and cytopathic storm, said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. While MSC-derived treatments have shown promise in treating patients with ARDS, including those with COVID-19, the ability to scale production to support the overwhelming patient need has been a challenge. Our proprietary GMP-in-a-Box enables the rapid and scalable manufacture of our fully human BM-Allo.MSC product, overcoming this previous limitation to advance a promising new treatment to those patients who are most in need. Due to our proprietary methods, we are well positioned to rapidly advance BM-Allo.MSC during the current wave of COVID-19, with an anticipated trial initiation in Q2.

BM-Allo.MSC is a bone marrow-derived allogenic MSC product being developed to attenuate the inflammatory processes that drive ARDS in severe COVID-19 patients. MSCs are multipotent progenitor cells that give rise to cell types responsible for tissue repair and may restore effective immune function and contribute to viral clearance. Prior work with allogeneic MSC products in patients with ARDS has shown that such treatment is safe and may reduce key markers of inflammatory processes.

Trial Design

The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting. The primary objectives of the study include overall safety and reduction in time on ventilator. The secondary objective will focus on the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering off-the-shelf living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer and/or Covid-19. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells, as well as other therapeutics, as part of the NANT Cancer Vaccine platform as a cancer treatment and/or Covid-19 treatment.

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients - Business...

Bone Marrow Stem Cells Comments Off on NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients – Business… | May 18th, 2020

Three arms of this trial will be leronlimab, remdesivir, and leronlimab + remdesivir

VANCOUVER, Washington, May 18, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be submitting a protocol to the U.S. Food and Drug Administration (FDA) for a factorial design trial to compare effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19.

Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyns Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.

We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from COVID-19. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for COVID-19, said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.

Unfortunately, COVID-19 remains a global public health challenge, and its economic impact continues to devastate the world economy. With a second wave of potential cases threatening to surface in the fall and winter of 2020, it is more important than ever to be sure successful treatment options are available to protect the lives of patients. CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone, said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir -...

Bone Marrow Stem Cells Comments Off on CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir -… | May 18th, 2020

DUBLIN, May 18, 2020 /PRNewswire/ -- The "Global Stem Cell Partnering Terms and Agreements 2010-2020" report has been added to ResearchAndMarkets.com's offering.

This report provides comprehensive understanding and unprecedented access to the stem cell partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Stem Cell partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Stem Cell agreements announced in the life sciences since 2010.

The report takes the reader through a comprehensive review Stem Cell deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Stem Cell partnering deals.

The report presents financial deal term values for Stem Cell deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Stem Cell partnering field; both the leading deal values and most active Stem Cell dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 600 online deal records of actual Stem Cell deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

The initial chapters of this report provide an orientation of Stem Cell dealmaking.

A comprehensive series of appendices is provided organized by Stem Cell partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in Stem Cell partnering and dealmaking since 2010.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Stem Cell technologies and products.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/9pqrta

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

http://www.researchandmarkets.com

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Global Stem Cell Partnering Deals Collection (2010-2020): Access to Headline, Upfront, Milestone and Royalty Data - PRNewswire

IPS Cell Therapy Comments Off on Global Stem Cell Partnering Deals Collection (2010-2020): Access to Headline, Upfront, Milestone and Royalty Data – PRNewswire | May 18th, 2020

DUBLIN--(BUSINESS WIRE)--The "Global Stem Cell Partnering Terms and Agreements 2010-2020" report has been added to ResearchAndMarkets.com's offering.

This report provides comprehensive understanding and unprecedented access to the stem cell partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Stem Cell partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Stem Cell agreements announced in the life sciences since 2010.

The report takes the reader through a comprehensive review Stem Cell deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Stem Cell partnering deals.

The report presents financial deal term values for Stem Cell deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Stem Cell partnering field; both the leading deal values and most active Stem Cell dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 600 online deal records of actual Stem Cell deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

The initial chapters of this report provide an orientation of Stem Cell dealmaking.

A comprehensive series of appendices is provided organized by Stem Cell partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in Stem Cell partnering and dealmaking since 2010.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Stem Cell technologies and products.

Analyzing actual contract agreements allows assessment of the following:

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/84edx3

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Global Stem Cell Partnering Terms and Agreements 2010-2020 - ResearchAndMarkets.com - Business Wire

IPS Cell Therapy Comments Off on Global Stem Cell Partnering Terms and Agreements 2010-2020 – ResearchAndMarkets.com – Business Wire | May 18th, 2020

ALAMEDA, Calif.--(BUSINESS WIRE)-- AgeX Therapeutics , Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the first quarter ended March 31, 2020.

The human tragedy of this pandemic has long tentacles that effect numerous businesses including AgeX, said Greg Bailey M.D., Chairman. Given the current global economic landscape, and the changes that businesses will need to make to accommodate to a post pandemic world, we feel that new business model aligns well to be able to function in this new environment. We see enormous opportunity to license and joint venture PureStem and HLA-G while implementing a definitive plan to begin preclinical trials on tissue regeneration under the leadership of Michael West and Michael May. We will update you in the future as these plans progress.

AgeX has completed a company restructuring to help set it up for success in the future. The combination of company priorities, cash position and the COVID-19 pandemic led to employee lay-offs designed to support the evolution of AgeX's current team to execute on strategic business goals going forward and to ensure cash is directed at near-term priorities to deliver maximum shareholder value. AgeX has a dual business strategy to diversify risk and maximize opportunities. It plans to continue to pursue its licensing and collaboration strategy for its two primary technology platforms, UniverCyte immunotolerance technology for the generation of universal cells, and PureStem cell derivation and manufacturing technology for the production of therapeutic cells with potential advantages, including industrial scalability and lower manufacturing costs. Since the launch of its licensing and collaboration strategy in January 2020, AgeX has delivered a research collaboration in Japan focused on developing universally transplantable cells for therapeutic use based on UniverCyte, entered into a neural stem cell therapy research collaboration for neurological disorders utilizing PureStem at a California University, and AgeX licensee ImStem Biotechnology received the first-ever clearance of a cell therapy derived from AgeXs embryonic stem cells by the FDA to enter human studies.

In addition, AgeX remains committed to pursuing in-house cell therapy product development and plans to raise money to build the optimal team to deliver on its products, AGEX-BAT1 for metabolic diseases such as type II diabetes and AGEX-VASC1 for tissue ischaemia. AgeXs budgetary and personnel adjustments will result in the deferral of in-house product development and may also lead to AgeX seeking arrangements with other companies in the cell therapy or biopharma industry for the development of its product candidates and technology, or outsourcing of some of that work to service providers until further funding can be obtained to rebuild in-house research and development staff for one or more of those programs. Development of AgeXs iTR technology may be done at AgeXs subsidiary Reverse Bioengineering, Inc. subject to successful financing of the subsidiary.

Upwards of 80% of healthcare expenditures in the United States relates to chronic degenerative disease and aging is a principle underlying cause of such conditions, said Michael D. West, Ph.D., AgeXs Chief Executive Officer. Therefore, the ability to manufacture to scale young clinical-grade cells capable of regenerating functionality in diverse tissues of the body has the potential to transform healthcare as we know it today. Perhaps even more noteworthy is the potential of reversing developmental aging in the body itself through AgeXs iTR technology. Our goal in the coming year is to advance the development of our intellectual property with the goal of bringing value to our shareholders.

Q1 Highlights

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. On April 1, 2020 AgeX drew the initial $500,000, and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on March 30, 2020 and May 14, 2020, respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan will bear interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the PPP to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX intends to use the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

During April 2020, AgeX initiated staff layoffs that affected 12 employees, primarily research and development personnel. AgeX has paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which are expected to be settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, and considering that loans from Juvenescence in excess of an initial $500,000 advance under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the $500,000 loan under the New Loan Agreement, the PPP Loan and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three months ended March 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

First Quarter 2020 Operating Results

Revenues: Total Revenues for the first quarter of 2020 were $515,000 as compared with $388,000 for the first quarter of 2019. AgeX revenue is primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $86,000 of allowable expenses under its research grant from the NIH as compared with $15,000 in the same period in 2019.

Operating expenses: Operating expenses reported for the three months ended March 31, 2020 were $3.7 million as compared to $3.4 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended March 31, 2020 were $3.2 million as compared to $2.8 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses increased by $0.3 million to $1.6 million during the three months ended March 31, 2020 from $1.3 million during the same period in 2019. The increase was primarily attributable to an increase of $0.2 million in scientific consultants, $0.2 million in laboratory facilities and equipment related expenses and maintenance, $0.1 million in personnel related expenses allocable to research and development, and $0.1 million in depreciation and amortization of laboratory equipment and improvements. These increases were offset to some extent by a decrease of $0.3 million in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of the Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses for the three months ended March 31, 2020 remained consistent with the same period in 2019 of $2.1 million despite bearing the full lease and facilities related costs since April 2019, and an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

March 31,

2020

December 31,

2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

468

$

2,352

Accounts and grants receivable, net

366

363

Prepaid expenses and other current assets

1,238

1,339

Total current assets

2,072

4,054

Property and equipment, net

898

1,126

Deposits and other long-term assets

111

111

Intangible assets, net

2,011

2,151

TOTAL ASSETS

$

5,092

$

7,442

LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)

CURRENT LIABILITIES

Accounts payable and accrued liabilities

$

2,184

$

1,582

Loan due to Juvenescence, net of debt issuance cost

1,767

-

Related party payables, net

181

64

Deferred revenues

407

283

Right-of-use lease liability

325

428

Insurance premium liability and other current liabilities

603

940

Total current liabilities

5,467

3,297

Loan due to Juvenescence, net of debt issuance cost

-

1,528

TOTAL LIABILITIES

$

5,467

$

4,825

Commitments and contingencies

STOCKHOLDERS EQUITY (DEFICIT)

Preferred stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding as of March 31, 2020 and December 31, 2019

-

-

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AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update - Insurance News Net

IPS Cell Therapy Comments Off on AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update – Insurance News Net | May 18th, 2020

MIKE TYSON has revealed he was injected with nearly-translucent blood in his bid to make a comeback... and the former heavyweight champ said it made him feel "weird".

The 53-year-old - who retired from boxing in 2005 - has announced his intention to dust off the gloves and return to compete in exhibition bouts.

2

His return to action has been aided by stem-cell research therapy, that has left him feeling like a "different person".

He said: "You know what I had done? I had stem-cell research therapy.

"I feel like a different person but I can't comprehend why I feel this way. It's really wild what scientists can do."

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition that usually takes the form of a bone marrow transplantation.

In a recent interview with rapper LL Cool J on the Rock the Bells Radio show on SiriusXM, Tyson opened up on the effects the treatment has had on him.

Commenting on the mental aspect of training for a fight for the first time in 15 years, he said: "My mind wouldnt belong to me.

"My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

"Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research."

Tyson was then asked whether that meant if his white blood had been spun and then put back in, to which he replied: "Yes. As they took the blood it was red and when it came back it was almost transfluid (sic).

"I could almost see through the blood, and then they injected it in me.

"And Ive been weird ever since, Ive got to get balanced now."

2

MAY DAYNew footage of Floyd's win vs McGregor makes legend look even more impressive

BACK IN GLOVEHolyfield CONFIRMS Tyson talks over epic trilogy with pair close to deal

IF LOOKS COULD KILLMayweather training because he is 'very conscious about how he looks'

GO WITH THE FLOMayweather 'passionate about becoming a trainer' despite comeback rumours

PUSH AND PULPulev plotting Fury fight after Joshua having already beat up cousin Hughie

WHAT IS STEM CELL TREATMENT USED FOR?

Stem cell transplants are carried out when bone marrow is damaged or isnt able to produce healthy blood cells.

It can also be used to replace damaged blood cells as the result of intensive cancer treatment.

Here are conditions that stem cell transplants can be used to treat:

Iron Mike has been called out by former rival Evander Holyfield to complete their trilogy following their two meetings in 1990s.

And his unusual methods for getting back in shape seem to be working.

Tyson is looking in incredible condition as he uploaded a clip of himself that showed off his ferocious power and speed.

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Mike Tyson reveals doctors gave him translucent blood injection that left him feeling weird during stem cel - The Sun

Bone Marrow Stem Cells Comments Off on Mike Tyson reveals doctors gave him translucent blood injection that left him feeling weird during stem cel – The Sun | May 17th, 2020