Category Archives: Stem Cell Treatment


Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndrome – The…

WARREN, N.J., April 9, 2020 /PRNewswire/ --Celularity Inc. ("Celularity" or the "Company"), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the expansion of its existing collaborative license agreement with United Therapeutics Corporation's (Nasdaq: UTHR) wholly-owned subsidiary, Lung Biotechnology PBC, to include the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS).

This announcement builds on recent pioneering work by Celularity for the use of its proprietary CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the coronavirus disease, COVID-19, and extends this application of the technology to ARDS. The U.S. Food and Drug Administration recently cleared Celularity's investigational new drug application (IND 019650) to evaluate CYNK-001's safety, tolerability, and efficacy for the treatment of COVID-19.

ARDS, the most devastating complication of COVID-19, is a serious inflammatory lung injury that causes hypoxemia, or below-normal oxygen level in the blood. Hypoxemia can lead to multi-organ system failure and death. Recent findings indicate that ARDS may develop in as many as 17-29% of COVID-19 patients who are hospitalized with pneumonia.

Celularity founder and Chief Executive Officer, Dr. Robert Hariri, said, "This promising, novel approach to treating COVID-19 and the pulmonary complications associated with this infection may unlock a powerful new therapeutic option for patients. The exceptional expertise in pulmonary disease, cellular medicine, and manufacturing makes this strategic collaboration particularly well suited to tackle this urgent, global medical crisis."

Under the amended collaborative agreement, Celularity will seek regulatory approval for CYNK-001 in COVID-19, and Lung Biotechnology will seek regulatory approval for CYNK-001 in ARDS. Lung Biotechnology has global rights under the amended collaborative agreement to commercialize CYNK-001 in COVID-19 and ARDS. The collaboration will be governed by a Joint Steering Committee to oversee development and commercialization activities. Financial terms were not disclosed.

Celularity's CYNK-001 is the only cryopreserved allogeneic, off-the-shelf Natural Killer (NK) cell therapy being developed from placental hematopoietic stem cells and is being investigated as a potential treatment option for various hematologic cancers and solid tumors, and is the first cell therapy granted an IND to treat COVID-19. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and virally infected cells and interacting with adaptive immunity. CYNK-001 cells derived from the postpartum placenta have been shown to be well-tolerated in early clinical trials and are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

Media and Investor RelationsMedia Contact:Factory PRcelularity@factorypr.com

Investor Relations Contact:John R. Haines, Executive Vice Presidentjohn.haines@celularity.com

About Celularity: Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory, infectious, and age-related diseases. To learn more, please visit http://www.celularity.com.

Forward-Looking Statements: This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks, and uncertainties that may cause actual results, the outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of the original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndrome - The...

British boy fighting rare cancer is discharged after coming to Singapore for experimental treatment – CNA

SINGAPORE: It was a moment of pure elation for the family of Oscar Saxelby-Lee the six-year-old has finally been discharged from hospital after staying cancer-free for nearly three months.

The British boy has been battling acute lymphoblastic leukaemia since December 2018, and arrived in Singapore forexperimental treatment at the National University Hospital (NUH) that only one other child in the world has received.

Doctors in the UK said that they had exhausted all conventional treatment and that there was only palliative care left for Oscar. Thefamily was told to prepare for the worst.

But after arriving in Singapore in November and starting treatment on Christmas Eve, Oscar has remained MRD (minimal residue disease) negative which means no cancer cells are detected for nearly three months.

He was discharged from hospital on Thursday (Apr 9) and will go back for check-ups every few days.

His mum Olivia told CNA it is the longest period her only son has remained cancer-free since he was diagnosed.

Oscar is defeating the odds. After being told end-of-life care was the only option left for Oscar about eight months ago, he has shown that miracles really do happen, she said.

He is the best he has been in a very long time full of life, living life and enjoying life again.

It has been a huge learning curve, and no doubt will continue to be, but we are grateful. Grateful for this chance, grateful for the team saving Oscars life and also grateful for the experience.

It still feels a little like a dream. We just cant believe it. NUH has saved Oscars life!

NUH TREATMENT WAS OSCARS LAST HOPE

The treatment in Singapore was Oscars last hope. All other treatments had failed to rid him of the cancer - he was still MRD positive after a stem cell transplant and rounds of chemotherapy.

The little boy from Worcester, England flew to Singapore after the family crowdfunded 500,000 (S$885,000) for a new form of treatment, in which immune cells from a patients blood is drawn and equipped with a Chimeric Antigen Receptor (CAR-T).

The receptor binds itself to a specific protein on the cancer cell and activates the CAR-T cells to kill the cancer cells.

This particular form of CAR-T treatment is different and more difficult because the leukaemia cells resemble Oscars immunity system, Associate Professor Allen Yeoh, head of paediatric oncology at NUH, explained previously.

This is compassionate treatment,which means it is not even in the medical trial stage yet.

By the time he arrived in Singapore, Oscar wasweak from the months in hospital isolation and from battling the rare blood cancer.

He got stronger and doctors started treatment on Christmas Eve. On Jan 15, his parents were told he was MRD negative but that was just the first major step towards a full recovery.

Over the last three months, Oscar has battled several conditions as a result of complications and undergone more surgeries and transplants.

He was diagnosed with both Graft versus host disease (GvHD) and Thrombotic microangiopathy(TMA) that caused him shaking spells, pain and weakness.

"WE NEEDED MUM HERE"

Over the last five months, Oscars family has remained in Singapore far from their loved ones in the UK.

Shortly before the COVID-19 pandemic broke out, Oscars grandmother Oomar travelled to Singapore to be with her grandson.

We needed her with us after such a long haul of trauma. She flew knowing of the risks (of contracting COVID-19) and was very worried, Olivia said.

Oomar completed her 14-day stay-home notice and was allowed to see Oscar just as he was overcoming the worst of the TMA.

This was the moment Oscar saw his grandmother for the first time in months:

Oscars life instantly became better, he was ecstatic, said Olivia.

She has been a huge lift for us all, for me especially as well. We all need our mums at times. An extra pair of hands, loving support and someone else to talk to.

The family will remain in Singapore and keep Oscar isolated at the apartmentwhere they've been staying as his immunity system is still recovering, and he will make frequent trips to outpatient clinics in hospital, his mum said.

He isnt out of the woods yet. Being post-transplant puts him even more at risk, and very vulnerable to not just COVID-19, but any cold or illness, she explained.

Thats nearly a year and a half of complete isolation and even in the future, we will have to be very vigilant.

"SINGAPORE IS AN AMAZING COUNTRY"

With the COVID-19 outbreak affecting countries around the world, including the UK and Singapore, the family will stay in Singapore until Oscar has been given the all-clear to fly home.

We all miss home. We miss our friends, our family, our society, our community, Olivia said.

We are really homesick, but we are safe, and we believe we are in the safest place. Singapore is an amazing country, and we feel privileged to be here, even at this difficult time.

We have met so many wonderful people here, from friends, to medics ... each has been an incredible support for us as a family.

Our lives have changed greatly.

The support has been so heartwarming. The well wishes and prayers truly mean so much to us. We are touched by peoples generosity, care and compassion for us as a family and cannot thank everyone both here and back home enough.

Its been one heck of a journey, and Im sure will continue to be, but the support makes it all that little easier.

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British boy fighting rare cancer is discharged after coming to Singapore for experimental treatment - CNA

Searching for an effective Covid-19 treatment: promise and peril – STAT

In response to the most serious global health threat in a century, the worlds biomedical establishment is unleashing an unprecedented response to the Covid-19 pandemic, rapidly increasing resources aimed at finding safe and effective treatments for the disease. But without careful attention to the pitfalls that can befall biomedical research and regulatory decision-making during a time of crisis, a lot can go wrong.

On March 28, the FDA provided emergency use authorization for hydroxychloroquine a medicine approved for treating malaria for people hospitalized with Covid-19. It also however, told health providers that the optimal dose and duration of treatment were unknown. The authorization did not identify any clinical study on which this approval was based, and while hydroxychloroquine may affect viral replication and might ultimately prove beneficial, its impact on health outcomes among patients with Covid-19 is currently unclear.

Against this potentially worrisome action, the scope of the search for a new treatment to mitigate or cure Covid-19 is breathtaking. One recent listing identified more than 70 candidate molecules, including 15 antivirals, potent suppressants of the human immune system, and high-risk oncology treatments already approved by the FDA to treat other conditions.

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The National Institutes of Healths ClinicalTrials.gov lists more than 100 clinical investigations focused on Covid-19 from around the world, with sponsors that include medical centers, pharmaceutical companies, and national research institutes. In time, it is likely we will see direct-acting antivirals tailored to the most vulnerable molecular targets on the SARS-CoV-2 virus.

But this extraordinary effort is lacking international coordination, which may yield counterproductive competition among countries with biotechnology industries. The coronavirus does not respect national boundaries; neither can the development of new treatments, which are already being tested in more than 15 countries. As a first step, the biomedical community needs to insist on consistent use of central registries of clinical studies and on early sharing of complete details of both successful and failed studies, and not withhold important scientific evidence as proprietary information.

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Acting against this effort is a growing industry fueled by fear and panic. Medical history has taught us that when people get sick and scared they will take practically anything. For centuries, worthless and sometimes harmful treatments, ranging from arsenic to swamp root, have been promoted by everyone from charlatans to well-meaning clinicians.

In an emergency situation such as this one, attention will naturally turn to repurposing already available products, which makes good sense. But we need to let scientists do their jobs. In too many past cases, drugs have been widely used off-label or based on a positive response in a narrow laboratory or clinical measure only to have independent analysis later show that the treatments do more harm than good or target the wrong patient population. For example, a family of anti-arrhythmic drugs that was effective in stopping asymptomatic irregular heartbeats was subsequently found to increase the risk of cardiac arrest when given to heart attack survivors.

The biomedical establishment must speak with a clear voice about the need to adequately test new drug treatments for Covid-19 and to subject that evidence to independent evaluation by the FDA.

Other pitfalls await those too ready to embrace a new treatment. One is the power of the placebo effect. Among individuals participating in clinical trials, those unaware they are receiving an inactive placebo can show substantial improvement, sometimes equal to 80% of the apparent treatment effect of the active therapy. The placebo effect has been documented in clinical trials assessing health benefits that range from improvement in subjective psychiatric symptoms to objective laboratory results.

Who has not read media reports about an individuals miraculous recovery at the hands of a caring physician trying an entirely new approach to treatment? Independent investigation of the case confirms the striking improvement was real. But it turns out to be a dramatic example of idiosyncratic recoveries that can be neither explained nor duplicated in other patients.

The coming flood of research from trials now or soon to be underway should lead us toward realistic and objective measures of the two fundamental properties of every therapeutic drug: benefit and harm.

A drug that shows disease activity against SARS-CoV-2 could prove too toxic to give to Covid-19 patients with worsening pneumonia. A claim that a drug reduces viral load could be valid, but its health benefits or harms could depend on when in the cycle of infection it is used. A drug intended for those with mild-to-moderate symptoms but who are otherwise healthy must be of low toxicity because it will be given to many patients who might have otherwise recovered on their own, while it may be more acceptable to offer drugs with more severe toxicities to patients at higher risk of death.

Another fundamental aspect of all drug testing is encouraging when it comes to Covid-19 research. As the first antibiotics for pneumonia taught us in the 1930s, a dramatically effective treatment for an acute illness can be convincingly demonstrated in a small number of patients observed over a few weeks time. The chances of discovering and documenting such a treatment grow if we also greatly increase the number of patients enrolled in clinical studies.

In the 1980s, during the HIV epidemic, patient advocacy groups not only helped shape the way clinical trials of the disease were conducted but served as a strong force for recruiting patients into trials of investigational drugs. A broad network of trial participants helped accelerate testing of drugs in the pipeline.

In the case of pediatric cancer, a collaborative professional network was established decades ago to ensure that all patients are enrolled in clinical trials at the time of initial diagnosis. These patients then get top-quality care and generate data to help future patients.

Supported by these forces, it is not surprising that both HIV and pediatric cancer have seen remarkable advances in care over the last 30 years.

It is a false choice to think that we can either have expeditious treatment options for SARS-CoV-2 or we can have rigorous testing of them. We can have both. Achieving that goal, however, will require avoiding missteps such as widely promoting unproven products so fearful people begin using them in inconsistent ways outside of the research enterprise. Instead, we will need international coordination of scientific goals, transparency of results, comprehensive participation in clinical research, and trials that evaluate meaningful outcomes. Doing that can ensure that any treatments that are developed do, in fact, benefit the patients who receive them.

G. Caleb Alexander, M.D., is a professor of epidemiology and medicine at the Johns Hopkins Bloomberg School of Public Health. Aaron S. Kesselheim, M.D., is a professor of medicine at Brigham and Womens Hospital and Harvard Medical School. Thomas J. Moore is a lecturer at George Washington University Milken Institute School of Public Health.

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Searching for an effective Covid-19 treatment: promise and peril - STAT

Cell therapy restores mobility and sensations in rodent models of stroke – FierceBiotech

Scientists at Lund University in Sweden showed long ago they could reprogram human cells into nerve cells and implant them into the brains of rats after a stroke. But would the cells form the vital connections needed to restore mobility and sensations like touch?

Now, they have early evidence that the answer to that question isyes. The Lund team turned skin cells into nerve cells, transplanted them into the brains of the rodent stroke models and observed them for six months. The new cells repaired the damage caused by strokes in the animals, the researchers reported in the journal PNAS.

The Lund University team transplanted the reprogrammed skin cells into the rats cerebral cortices, the region of the brain thats most commonly damaged by stroke. Then they used electron microscopy and other technologies to track the cells. That allowed them to see that the cells were making the connections needed to repair damaged nerve circuits.

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We have been able to see that the fibers from the transplanted cells have grown to the other side of the brain, the side where we did not transplant any cells, and created connections, said co-author Zaal Kokaia, professor of neurology at Lund, in a statement.

RELATED: Restoring neurons to preserve memory after heart attack or stroke

Cell therapy has been proposed for treating stroke damage in the past, but efforts to make it a reality have hit some roadblocks. A stem cell therapy being developed by British biotech ReNeuron failed to hit its primary trial endpoint of improving arm and leg movements. ReNeuron has since turned in better results from a trial of its cell therapy for improving vision in patients with retinitis pigmentosa.

Meanwhile, academic researchers are testing a variety of other therapies aimed at repairing stroke damage. Last year, for example, Stanford researchers showed that blocking a particular microRNA prompted star-shaped brain cells called astrocytes to become neurons, which helped restore memory in rats.

The Lund team is now planning additional animal trials to study how their transplanted cells affect memory and other intellectual functions, they said. They will also watch the rats closely to make sure they arent experiencing side effects, and theyll study the impact of the transplants on regions of the brain.

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Cell therapy restores mobility and sensations in rodent models of stroke - FierceBiotech

What’s the best COVID-19 treatment? Science *real* science will tell us – Patheos

Erlenmeyer Laboratory Chemistry Science Flasks, from http://maxpixel.freegreatpicture.com/Erlenmeyer-Laboratory-Chemistry-Science-Flasks-606611

Is hydroxychloroquinine an effective treatment for COVID-19*?

Are ventilators effective in treating patients as the disease worsens?

Why are African-Americans dying in greater numbers?

Lets talk science.

How many times have you heard the phrase the science is settled? Thats been repeated endlessly with respect to climate change, but, in fact, the reality of science is that it is never settled.

Many years ago, as a student of history, I had a class in historiography in which the professor aimed to provide readings that would broaden the students understanding in a wider way than merely instruction in research methods. We read about Cargo Cults in a book called Cows, Pigs, Wars, and Witches, and we read about paradigm shifts in the classic The Structure of Scientific Revolutions, by Thomas Kuhn. (Yes, reader, when I read the book, I believed the word was pronounced para-dig-m instead of para-dime.) Heres how Wikipedia summarizes his argument:

Kuhn challenged the then prevailing view of progress in science in which scientific progress was viewed as development-by-accumulation of accepted facts and theories. Kuhn argued for an episodic model in which periods of conceptual continuity where there is cumulative progress, which Kuhn referred to as periods of normal science, were interrupted by periods of revolutionary science. The discovery of anomalies during revolutions in science leads to new paradigms. New paradigms then ask new questions of old data, move beyond the mere puzzle-solving of the previous paradigm, change the rules of the game and the map directing new research.

And permit me to cite two examples from medical research outside the coronavirus.

First, stem cell transplants for breast cancer.

Back, well, when the internet was in its infancy and one learned about news through actual newspapers, I recall reading about stem cell transplants, then watching the process play out for a relative of a friend, who was diagnosed with breast cancer and, as it advanced, treated with a stem cell transplant for those who dont recall, this was a method in which the patients stem cells were removed, then the patient received extremely high doses of chemotherapy, to completely kill the cancer but, as a consequence, destroying the immune system, and then the stem cells were re-infused. The risks of the procedure were great but it was believed that the reward was greater but, as it happened, my friends relative died. Now, doctors were so convinced of the efficacy of the treatment that insurance companies were pressured to cover it despite its experimental nature, and that the usual protocols of randomized controlled trials (RCT) were not followed because, after all, to deny half a test population a lifesaving treatment would consign them unfairly to death.

You may know the end of the story: when a RCT was finally conducted in 2000, it found that this procedure actually offered patients no benefit compared to conventional treatment. (You can read the whole story at Health Affairs.)

Second, research into Alzheimers Disease, and, more specifically, the amyloid hypothesis, that is, the theory that sticky brain plaques cause Alzheimers and that removing or preventing those plaques will cure or prevent the disease.

This theory became entrenched in the research for Alzheimers; a video at STAT describes the manner in which researchers moved from one failed drug trial to the next based on this theory. But heres an editorial at that publication from April of 2019:

If insanity is doing the same thing over and over again but expecting different results, then the last decade or so of Alzheimers disease drug development has been insane. Three carefully designed, well-executed, and fully resourced trials targeting amyloid protein in the brain as the cause of Alzheimers disease have failed. Its long past time to take a new approach to this mind-robbing disease. . . .

A comfortable partnership developed between believers in the amyloid hypothesis, funding agencies, and drug companies, so that only programs supporting this hypothesis were funded. Even today, the largest amount of NIH funding for Alzheimers disease research goes to amyloid-0related research.

Following the advice of their academic advisers most of them members of the amyloid cabal drug companies dutifully developed drugs to target amyloid with the goal of treating Alzheimers disease. Thy believed it was only a matter of time before the Alzheimers problem was solved. . . .

Other ideas were starved of funding or greeted with polite rolling of the eyes. . . .

This is a good place to talk about groupthink, the psychological phenomenon that occurs within a group of people in which the desire for harmony or conformity results in irrational or dysfunctional decision-making. Groupthink describes the funding and execution of Alzheimers disease research and drug development over the last 30 years. Once amyloid became the target, all other ideas were abandoned, shunned, even ridiculed. Although I believe that this dark period is behind us, weve wasted three decades and billions of dollars.

Trump is promoting the possible use of hydroxychloroquinine as a treatment for the disease. Is he doing so recklessly? Are naysayers naysaying for scientific grounds or anti-Trump grounds?

One of the key issues is that there have not yet been RCTs for this treatment. In a disease such as COVID-19, where the large majority of people do recover, one way or the other, touting one treatment or another as a breakthrough without following a protocol of a control group cannot produce valid results, but here the French doctor who has been promoting this treatment, in combination with azithromycin, Didier Raoult, has been doing exactly this, by claiming that his treatment is so clearly successful that it would unethical to deny it to his patients. (See this Forbes article for a distillation of the debate, and a Q&A at The Hospitalist for some further scholarly comments.)

But hydroxychloroquinine is not the only aspect of the pandemic where conventional wisdom and science are at odds.

Second, ventilators: heres a report from STAT on April 8th: With ventilators running out, doctors say the machines are overused for Covid-19.

Even as hospitals and governors raise the alarm about a shortage of ventilators, some critical care physicians are questioning the widespread use of the breathing machines for Covid-19 patients, saying that large numbers of patients could instead be treated with less intensive respiratory support.

If the iconoclasts are right, putting coronavirus patients on ventilators could be of little benefit to many and even harmful to some.

Whats driving this reassessment is a baffling observation about Covid-19: Many patients have blood oxygen levels so low they should be dead. But theyre not gasping for air, their hearts arent racing, and their brains show no signs of blinking off from lack of oxygen.

That is making critical care physicians suspect that blood levels of oxygen, which for decades have driven decisions about breathing support for patients with pneumonia and acute respiratory distress, might be misleading them about how to care for those with Covid-19. In particular, more and more are concerned about the use of intubation and mechanical ventilators. They argue that more patients could receive simpler, noninvasive respiratory support, such as the breathing masks used in sleep apnea, at least to start with and maybe for the duration of the illness.

This is not just a matter of trying to save money or resources by minimizing the use of ventilators. As the article reports, ventilation can actually cause harm: Older patients who do survive risk permanent cognitive and respiratory damage from being on heavy sedation for many days if not weeks and from the intubation.

And patients with COVID-19 who are placed on ventilators have an extremely high fatality rate: in one instance, 30 of 37 patients placed on mechanical ventilation died within a month. In another, only one out of seven patients older than 70, placed on a ventilator, survived.

Whats more,

one of the most severe consequences of Covid-19 suggests another reason the ventilators arent more beneficial. In acute respiratory distress syndrome, which results from immune cells ravaging the lungs and kills many Covid-19 patients, the air sacs of the lungs become filled with a gummy yellow fluid. That limits oxygen transfer from the lungs to the blood even when a machine pumps in oxygen, [Harvard Medical School physician Dr. Muriel] Gillick said.

All of which leads to the question: should RCTs be conducted for the treatment of using ventilators for COVID-19, rather than doctors assuming that this is an effective treatment because it is used for other respiratory diseases?

And, finally, heres a highly speculative observation coming out of a Facebook group:-thalassaemia (or beta-thalassaemia, or thalassemia without the ae) is a blood disorder which is connected to anemia. (Heres a lay description of the disorder.) This disorder is inherited, and the mild form causes no health issues so that carriers will pass on the disorder; it is common in the Mediterranean and the Middle East in the same manner as sickle-cell anemia is found in Africa and among individuals with African ancestry; in both cases, the mild form of the trait conferred protection against malaria.

What does this have to do with anything? Thalassaemia is prevalent in the Po valley, which is the region in northern Italy which is being hardest hit by COVID-19. At the same time, within the US, blacks (that is, people of African descent) are disproportionately likely to die of COVID-19. Within the US, this is being explained as due to socioeconomic disparities in that population and there clearly are significant disparities but is the paradigm that all health disparities are caused by socioeconomic disparities because race is only a social construct preventing researchers from identifying physiological differences, and, as a result, limiting scientists understanding of how to treat the disease?

In any event, the more I read, the stronger I feel that the answer to the search for a treatment for coronavirus will hinge on our scientists ability to look beyond groupthink and get at the basic science that underlies the disease, whatever that may be.

*Look, Id love to call it the Wuhan Virus, the Chinese Flu, or any other such phrase that communicates the role that China played in causing/exacerbating the pandemic, and I quite like the backronym, or alternative acronym, China-originated virus in December 19 (rather than COronaVIrus Disesase), but, lets face it, we need a common nomenclature.

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What's the best COVID-19 treatment? Science *real* science will tell us - Patheos

Stem Cell Therapy Market Size 2020 | Top Companies, Growth Overview, Technology, Latest Trends and Forecast 2026 – Curious Desk

New Jersey, United States:The new report has been added by Verified Market Research to provide a detailed overview of the Stem Cell Therapy Market. The study will help to better understand the Stem Cell Therapy industry competitors, the sales channel, Stem Cell Therapy growth potential, potentially disruptive trends, Stem Cell Therapy industry product innovations and the value / volume of size market (regional / national level, Stem Cell Therapy- Industrial segments), market share of the best actors / products.

Information has been added to the report to provide a realistic view of the industry based on data from Stem Cell Therapy manufacturers, i.e. H. Shipping, price, sales, gross profit, business distribution, etc., SWOT analysis, consumer preference, current developments and trends, drivers and limiting factors, company profile, investment opportunities, analysis of the demand gap, market size value / volume, services and products, Porters five models , socio-economic factors, official regulations in the Stem Cell Therapy branch. Market participants can use the report to take a look at the future of the Stem Cell Therapy market and make significant changes to their operating style and marketing tactics in order to achieve sustainable growth.

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The Stem Cell Therapy Sales Market Report mainly contains the following Manufacturers:

Market Competition

The competitive landscape of the Stem Cell Therapy market is examined in detail in the report, with a focus on the latest developments, the future plans of the main players and the most important growth strategies that they have adopted. The analysts who compiled the report have created a portrait of almost all of the major players in the Stem Cell Therapy market, highlighting their key commercial aspects such as production, areas of activity and product portfolio. All companies analyzed in the report are examined on the basis of important factors such as market share, market growth, company size, production, sales and earnings.

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Assessment of sales channels

innovation trends

sustainability strategies

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Market entry analysis

market size and forecast

The geographic department provides data that give you an overview of the turnover of companies and sales figures for the growth activity Stem Cell Therapy for electrical meters. Here are the strengths of the geographic divisions: North America (United States, Canada and Mexico), Europe (Germany, Spain, France, Great Britain, Russia and Italy and more), Asia-Pacific (China, Japan, Korea, India and Southeast Asia) and more ), South America (Brazil, Argentina, Colombia), the Middle East and Africa (Saudi Arabia, United Arab Emirates, Egypt, Nigeria and South Africa) and ROW.

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Table of Content

1 Introduction of Stem Cell Therapy Market1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology 3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Stem Cell Therapy Market Outlook4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Stem Cell Therapy Market, By Deployment Model5.1 Overview

6 Stem Cell Therapy Market, By Solution6.1 Overview

7 Stem Cell Therapy Market, By Vertical7.1 Overview

8 Stem Cell Therapy Market, By Geography8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Stem Cell Therapy Market Competitive Landscape9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix11.1 Related Research

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Stem Cell Therapy Market Size 2020 | Top Companies, Growth Overview, Technology, Latest Trends and Forecast 2026 - Curious Desk

Animal Stem Cell Therapy Market Forecast 2020-2025, Latest Trends and Opportunities – Express Journal

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Animal Stem Cell Therapy Market Forecast 2020-2025, Latest Trends and Opportunities - Express Journal

Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients – Newswise

Newswise (New York, NY April 9, 2020) Mount Sinai Health System is the first in the country to use an innovative allogeneic stem cell therapy in COVID-19 patients and will play a central role in developing and conducting a rigorous clinical trial for patients with severe acute respiratory distress syndrome, the breathing illness that afflicts people who have severe cases of COVID-19.

The therapy, known as remestemcel-L, has previously been tested in bone marrow transplant patients, who can experience an overactive immune response similar to that seen in severe cases of COVID-19.

Mount Sinai began administering the therapy, known as remestemcel-L, to patients in late March under the Food and Drug Administrations compassionate use program, which allows patients with an immediately life-threatening condition to gain access to an investigational therapy. Ten patients with moderate to severe cases of COVID-19-related acute respiratory distress syndrome (ARDS), most of whom were on ventilators, were given the therapy and doctors saw encouraging results.

We are encouraged by what we have seen so far and look forward to participating in the randomized controlled trial starting soon that would better indicate whether this is an effective therapy for patients in severe respiratory distress from COVID-19, said Keren Osman, MD, Medical Director of the Cellular Therapy Service in the Bone Marrow and Stem Cell Transplantation Program at The Tisch Cancer Institute at Mount Sinai and Associate Professor of Medicine (Hematology and Medical Oncology) at the Icahn School of Medicine at Mount Sinai. Dr. Osman oversaw the treatment of the first Mount Sinai patients with this innovative therapy.

Under the leadership of Annetine Gelijns, PhD, Alan Moskowitz, MD, and Emilia Bagiella, PhD, of Mount Sinais Institute of Transformative Clinical Trials, Mount Sinai will serve as the clinical and data coordinating center for a randomized clinical trial evaluating the therapeutic benefit and safety of this stem cell therapy in 240 patients with COVID-related ARDS in the United States and Canada. The trial will be conducted as a public-private partnership between the Cardiothoracic Surgical Trials Network, which was established as a flexible clinical trials platform by the National Heart, Lung, and Blood Institute, and Mesoblast, the manufacturer of the cells.

The coronavirus pandemic has caused exponential increases of people suffering with acute respiratory distress syndrome, requiring intubation and mechanical ventilation with many dying, said Dr. Gelijns, who is also the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai. We have designed a clinical trial that will expeditiously determine whether the stem cell therapy will offer a life-saving therapy for a group of patients with a dismal prognosis.

We are interested to study the potential of this anti-inflammatory cell therapy to make an impact on the high mortality of lung complications in COVID-19 patients, said CSTN Chairman A. Marc Gillinov, MD. This randomized controlled trial is in line with our mandate to rigorously evaluate novel therapies for public health imperatives.

The therapy consists of mesenchymal stem cells. These cells are found in bone marrow and serve many functions including aiding tissue repair and suppressing inflammation. The therapy was previously tested in a phase 3 trial in children who had an often-fatal inflammatory condition called graft-versus-host disease (GVHD) that can occur after bone marrow transplants.

The inflammation that occurs in GVHD is the result of a cytokine storm, which activates immune cells that attack healthy tissue. A similar cytokine storm that causes damage to the lungs and other organs appears to be taking place in COVID-19 patients who develop acute respiratory distress syndrome, said John Levine, MD, Professor of Medicine (Hematology and Medical Oncology), and Pediatrics, at the Icahn School of Medicine at Mount Sinai, who helped implement the compassionate use of the drug at Mount Sinai.

These stem cells have shown excellent response rates in severe graft-versus-host disease in children, said Dr. Levine, who is also the co-director of the Mount Sinai Acute GVHD International Consortium (MAGIC). Mesenchymal stem cells have a natural property that dampens excessive immune responses.

Several people were instrumental in quickly and efficiently working through the complex application process for each patient to gain compassionate use of the therapy. Three key players involved were Stacey-Ann Brown, MD, MPH, Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine) at the Icahn School of Medicine at Mount Sinai; Tiffany Drummond, Assistant Director of Regulatory Affairs at The Tisch Cancer Institute at Mount Sinai; and Camelia Iancu-Rubin, PhD, Director of the Cellular Therapy Laboratory at the Icahn School of Medicine at Mount Sinai.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality carefrom prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 onU.S. News & World Report's"Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally byU.S. News & World Report.

For more information, visithttps://www.mountsinai.orgor find Mount Sinai onFacebook,TwitterandYouTube.

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Mount Sinai Leading the Way in Innovative Stem Cell Therapy for COVID-19 Patients - Newswise

First Stem Cell Clinical Trial for Protection Against COVID-19 Approved by FDA – HospiMedica

The FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences (Sugar Land, TX, USA) autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. MSCs are well-known for their immunomodulatory and regenerative potential. In a recent Phase I/II clinical trial for rheumatoid arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation. In COVID-19 patients, inflammation is a driving force behind disease progression, and it is critical to regulate the immune system as early as possible.

This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health conditions, or are at high-exposure risk. The studys primary objective is to determine the efficacy of HB-adMSCs to prepare the immune system so that it is better able to fight the virus, should one become infected. Hope anticipates that this pretreatment will limit the progression and severity of COVID-19, ultimately keeping patients out of the hospital and off of mechanical ventilation. HB-adMSCs are administered via five intravenous infusions over a fourteen-week period and follow-up evaluations through six months. All participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalization.

This is the first of three New Drug Applications (INDs), related to COVID-19, that Hope has filed with FDA. This initial protocol is specifically designed for patients who already have their own stem cells banked with the company. The next two protocols will utilize a donor cell source that will aim in protecting against COVID-19 for those at high risk (patients and frontline workers) and treating hospitalized patients.

This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments. Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patients own fat tissue. Most people who have been severely affected by COVID-19 had preexisting conditions. We are pretreating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus said Donna Chang, President and CEO of Hope Biosciences.

Our ultimate goal is to prevent anyone from needing mechanical ventilation. We believe that interceding early in the inflammatory process will give us the best possible outcome. Treating the disease is very important but if we have a chance to prevent the condition, we must explore all options. We appreciate the FDAs willingness to take this groundbreaking approach at such a critical time for our nation added Chang.

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First Stem Cell Clinical Trial for Protection Against COVID-19 Approved by FDA - HospiMedica

Moving toward Nonchemotherapy-Based Approaches in Follicular Lymphoma – Cancer Network

Nonchemotherapy-based approaches, including PI3K inhibitors and a more widespread use of allogeneic stem cell transplant, are being explored as treatments for patients with follicular lymphoma, according to Michael L. Grossbard, MD, who added that CAR T-cell therapy is also being evaluated.

As time has gone by, we have tried to move more toward nonchemotherapy brute force approaches to managing follicular lymphoma, said Grossbard, a professor in the Department of Medicine, chief of the Hematology and Medical Oncology Inpatient Service at Tisch Hospital, NYU Langone Healths Perlmutter Cancer Center.

Grossbard, who is also section chief of Hematology at NYU Langone Healths Perlmutter Cancer Center, spoke withOncLive,CancerNetworks sister publication, about these recent developments in the field of follicular lymphoma.

Follicular lymphoma is easy to get into remission with a lot of the new therapies we have, but there is a continuous period of relapse. Patients are not cured with their initial therapy Grossbard explained. Maintenance rituximab (Rituxan) is very helpful because you can use a targeted monoclonal antibody to prolong remissions, which may not have an impact on long-term survival, but prolonging remissions for patients is really important. For a patient, not having disease means a lotemotionally and psychologicallyin terms of quality of life.

According to Grossbard, minimal residual disease (MRD) may help measure the length of remission for a patient; however, there are no studies in follicular lymphoma that currently show that achievement of MRD is critical.

There are a lot of studies that have looked at MRD in follicular lymphoma. Some of those studies go back more than 20 years, which originally showed that the only modality we had to get patients to an MRD-negative state was transplant, said Grossbard. Now, with rituximab and other targeted therapies, we can actually achieve that MRD-negative state with more minimalist approaches.

Another treatment option that Grossbard highlighted were PI3K inhibitors, which are yet another targeted therapy for follicular lymphomas.

We understand more about B cells gone awry, which are the essence of what lymphoma is. The B-cell receptor pathway is triggered by the number of enzymes in a cascade, Grossbard explained. One of those [enzymes] is PI3K, and by blocking that particular enzyme, we can block the growth and proliferation of B cells and cause the killing of lymphoma cells.

However, in order to determine which type of PI3K inhibitor a patient should receive, Grossbard indicated that there are no clear guidelines to be followed, as it depends on personal experience and comfort with the drugs. He recommends becoming familiar with 1 or more of them in order to see where they fit into a patients treatment course.

For patients with heavily pretreated follicular lymphomas, Grossbard indicated that allogeneic transplant opens an option for potential cure, even in later stages and those with more advanced and refractory disease. However, this therapy option is typically not recommended unless a patient has been extensively pretreated.

Patients who have been through multiple chemotherapy regimens, multiple biological therapy regimens, and still have a good performance status and a tolerable amount of comorbid disease would fall into that sweet spot of considering allogeneic stem cell transplant, said Grossbard. Still, even though we do a lot better with managing toxicities than we used to, there are significant potential adverse events of graft-versus-host disease and other complications of allogenic transplant.

When asked about the status of venetoclax (Venclexta) in follicular lymphoma, a BCL2 inhibitor, Grossbard suggested that there is still a lot that is unknown. Venetoclax is currently approved for use in chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia.

In theory, venetoclax should be a marvelous drug for follicular lymphoma, but the response rates in follicular lymphoma with single-agent venetoclax have been a little more disappointing than we would have anticipated, Grossbard said. Venetoclaxs place in follicular lymphoma still remains to be defined.

This article was adapted from an article that originally appeared on OncLive, titled Follicular Lymphoma Moves Toward Chemo-Free Regimens.

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Moving toward Nonchemotherapy-Based Approaches in Follicular Lymphoma - Cancer Network