Study Identifies Pitfall for Correcting Mutations in Human Embryos with CRISPR – Columbia University Irving Medical Center

In a paper published today in the journal Cell, scientists describe unexpected, undesirable outcomes after editing genes in human embryos with CRISPR, a genomic editing system.

The study, the most detailed analysis to date of CRISPR in human embryos, shows that applying gene editing technologyto repair a blindness-causing gene early in the development of a human embryo often eliminates an entire chromosome or a large section of it.

"Our study shows that CRISPR/Cas9 is not yet ready for clinical use to correct mutations at this stage of human development, says the studys senior author Dieter Egli, assistant professor of developmental cell biology in the Department of Pediatrics at Columbia University Vagelos College of Physicians and Surgeons.

The genome editing system called CRISPR/Cas9 has revolutionized molecular biology in recent years, and its discoverers were honored with this year's Nobel Prize in chemistry. The system allows scientists to make precise changes in the genomes of cultured cells, living tissues, and animal embryos.

The first use of CRISPR in human embryos was reported in 2015. Then in 2018, He Jiankui claimed to have performed the procedure in a pair of twin embryos, eliciting a firestorm of condemnation from scientists and government officials worldwide.

In the new paper, Egli and his colleagues tested CRISPR/Cas9 genome editing's effects on early-stage human embryos carrying a mutation in a gene called EYS (eyes shut homolog), which causes hereditary blindness.

We know from previous studies in differentiated human cells and in mice that a break in the DNA results in mostly two outcomes: precise repair or small local changes. At the EYS gene, these changes can yield a functional gene, though it is not a perfect repair, says Michael Zuccaro, a research scientist at Columbia University Vagelos College of Physicians and Surgeons and co-lead author of the paper.

When Zuccaro, Egli, and their colleagues looked at the entire genomes of the modified embryos in this study, they identified another outcome. We learned that in human embryonic cells, a single break in the DNA can result in a third outcomethe loss of an entire chromosome or sometimes a large segment of that chromosome, and this loss of the chromosome is very frequent, says Zuccaro.

In 2017, a study reported the successful correction of a heart disease-causing mutation in normal human embryos using CRISPR. Comprehensive data from the new study offer a different interpretation of these results: Instead of being corrected, the chromosome carrying the mutation may have been lost altogether.

"If our results had been known two years ago, I doubt that anyone would have gone ahead with an attempt to use CRISPR to edit a gene in a human embryo in the clinic," Egli says.Our hope is that these cautionary findings should discourage premature clinical application of this important technologybut can also guide responsible research to achieve its ultimate safe and effective use.

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Study Identifies Pitfall for Correcting Mutations in Human Embryos with CRISPR - Columbia University Irving Medical Center

Yale New Haven Health Docs: Interpreting the Uptick in Covid-19 Cases – Greenwich Free Press

At a press conference this week, doctors from Yale New Haven Health System gave a snapshot of the Covid-19 uptick in Connecticut.

On Tuesday the System had 90 inpatients, more than 3-1/2 times the number at the end of September.

In the past two weeks the System had seen a 50% increase from 64 on Oct 13th to 92 cases on Monday.

A month ago there were only two Covid patients in the Systems ICUs. On Tuesday there were 22 with eight on ventilators. That was after many days with no ventilated Covid-positive patients.

While the numbers represent an uptick, they are still well below the peak of 800 cases last spring.

But it doesnt feel very good, said CEO Marna Borgstron. People are tired. Tired of the pandemic. Tired of social distancing. Tired of wearing masks.

As of Tuesday, the 90 Covid-19 cases across the System were as follows:

51 at Yale New Haven Hospital 16 at Bridgeport Hospital 11 at Lawrence and Memorial Hospital in New London 5 at Greenwich Hospital 6 at Westerly Hospital.

Dr. Tom Balcezak, Chief Medical Officer for the System, and Yale New Haven Hospital Infectious Disease Specialist Dr. Onyema Ogbuagu, who is working on the Pfizer trial for a vaccination and is deeply involved in care for Covid-19 patients, talked about the recent uptick.

We didnt know that (mask wearing) worked in the first part of this pandemic, Balcezak said. There is now scientific certainty that mask wearing and social distancing does work.

How Bad Will It Get?

Balcezak said it was impossible to forecast numbers or predict when a peak might come.

He said a wastewater sampling model showed the Greenwich area was seeing some slow growth, and the hot spot area to watch was eastern Connecticut.

As for Thanksgiving and Halloween, Balcezak said, We all have families and desire to reconnect with out families and friends, but this is not the time to be doing that.

Implications for Flu Season

Balcezak said with the arrival of fall, there was the potential for a flu pandemic in addition to Covid-19. He urged residents to get flu shots to avoid a twindemic of flu and Covid-19.

Dr. Ogbuagu said there was concern about how the flu would mimic Covid-19.

Balcezak agreed, adding the challenge wold be to sort out flu patients from Covid patients, who need different therapies and cohorting.

Balcezak said the southern hemisphere foreshadows what might be in store for Connecticut.

It appears the southern hemisphere had a very light flu season this year, he said. But we need to do everything we can to lock that in. That means getting your flu shot this year. We dont need our emergency departments and doctors offices clogged with folks that have respiratory illness.

Vaccine Trial at Yale New Haven Hospital with Pfizer

Dr. Ogbuagu said there are 300 people in the trial in New Haven. The target number is 44,000, which they are approaching, as the trial is multinational.

Enrollment is going well. Up to 70% of participants have already received the second of two vaccines. (The second vaccine comes three weeks after the first.)

I think the earliest a vaccine would receive approval would be end of December or January 2021, at best, Dr. Ogbuagu said.

Its been incredible to watch the speed with which our science has moved with this pandemic, Balcezak said. Were already talking about novel therapeutics and hopefully will have a vaccine approved in the next couple of months.

Balcezak added that when the first vaccine becomes available, it might not be the best vaccine, and wont prevent the virus.

He explained when the Covid-19 virus enters the body through the respiratory system, the immunity will stop it replicating, but the vaccine will not prevent infection. It will prevent symptoms but vaccinated people could still be contagious.

We may have to wait for a vaccine that prevents infection, he said. Even if you have got the vaccine, you will still be infectious. Therefore, mask wearing will still be the standard.

Dr. Ogbuagu said the Pfizer trial has already gone through phases 1 and 2, and the phase 3 trials are advanced. The trials are randomized. Half the people receive the vaccine and the others receive a placebo.

Dr. Ogbuagu said the study has a diverse enrollment, and not only enrolls adults and elderly individuals, but also enrolls pediatric age participants from age 12 +, and immune-compromised patients including HIV patients. Over half the people enrolled in the trial identify as racial minorities.

Asked about the use of embryonic stem cells in some vaccine trials, Dr. Ogbuagu said that scenario was not unique to Covid vaccines.

There were vaccines long before Covid, like Rubella, which is German measles, and shingles vaccines, which have utilized human embryonic cells to advance development, he said.

Dr. Balcezak said it was important to note that these are tissues have been grown over many years.

They are involved in early development, he said. But for large scale mass production of these vaccines, theyre going to use traditional manufacturing methodologies that dont involve stem cells.

Why are Covid-19 Illnesses Less Severe than in the Spring?

Dr. Balcezak said much had been learned about treating Covid-19 patients.

Were more liberal with the use of steroids than we were early on, he said. And we have figured out what medications do not work.

Theres been a lot of negative studies whether it be Hydroxychloroquine, or Azithromycin weve stopped the utilization of those drugs, Balcezak said.

We continue to use Rendesivir, which seems to have a small benefit, at least in terms of length of hospitalization.

He said theyd also learned more about non therapeutic therapies.

Its putting patients on their bellies, or proning them. Its how you manage the ventilator and how you use oxygen and high flow oxygen, he said. Weve seen mortality rates fall substantially.

Balcezak cautioned, Doing better was far from perfect, and while the System is seeing a small number of deaths compared to the spring, theyd like to see the number fall to zero.

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Outlook for stem cell therapy – its role in tendon regeneration – different treatments for horse tendon injuries – Trainer Magazine

After a tendon injury occurs, horses need time off work with a period of box rest. Controlled exercise is then introduced, which is built up slowly to allow a very gradual return to work. This controlled exercise is an important element of the rehabilitation process, as evidence suggests that exposing the tendon to small amounts of strain has positive effects on the remodelling phase of tendon healing. However, depending on the severity of the initial injury, it can take up to a year before a horse can return to racing. Furthermore, when tendon injuries heal, they repair by forming scar tissue instead of regenerating the normal tendon tissue. Scar tissue does not have the same strength and elasticity as the original tendon tissue, and this makes the tendon susceptible to re-injury when the horse returns to work. The rate of re-injury depends on the extent of the initial injury and the competition level that the horse returns to, but re-injury rates of up to 67% have been reported in racing thoroughbreds. The long periods of rest and the high chance of re-injury therefore combine to make tendon injuries the most common veterinary reason for retirement in racehorses. New treatments for tendon injuries aim to reduce scar tissue formation and increase healthy tissue regeneration, thereby lowering the risk of horses having a re-injury and improving their chance of successfully returning to racing.

Over the past 15 years, the use of stem cells to improve tendon regeneration has been investigated. Stem cells are cells which have the remarkable ability to replicate themselves and turn into other cell types. Stem cells exist from the early stages of development all the way through to adulthood. In some tissues (e.g., skin), where cells are lost during regular turnover, stem cells have crucial roles in normal tissue maintenance. However, in most adult tissues, including the tendon, adult stem cells and the tendon cells themselves are not able to fully regenerate the tissue in response to an injury. In contrast, experimental studies have shown that injuries to fetal tissues including the tendon, are capable of undergoing total regeneration in the absence of any scarring. At the Animal Health Trust in Newmarket, we have an ongoing research project to identify the differences between adult and fetal tendon cells and this is beginning to shed light on why adult cells lead to tendon repair through scarring, but fetal cells can produce tendon regeneration. Understanding the processes involved in fetal tendon regeneration and adult tendon repair might enable new cell based and/or therapeutic treatments to be developed to improve tendon regeneration in adult horses.

In many tissues, including fat and bone marrow, there is a population of stem cells known as mesenchymal stem cells (MSCs). These cells can turn into cells such as bone, cartilage and tendon in the laboratory, suggesting that they might improve tendon tissue regeneration after an injury. MSC-based therapies are now widely available for the treatment of horse tendon injuries. However, research has demonstrated that after injection into the injured tendon, MSCs do not turn into tendon cells. Instead, MSCs produce factors to reduce inflammation and encourage better repair by the tissues own cells. So rather than being the builders of new tendon tissue, MSCs act as the foreman to direct tissue repair by other cell types. Although there is some positive data to support the clinical application of MSCs to treat tendon injuries in horses, placebo controlled clinical trial data is lacking. Currently, every horse is treated with its own MSCs. This involves taking a tissue biopsy (most often bone marrow or adipose tissue), growing the cells for 2-4 weeks in the laboratory and then injecting them into the site of injury. This means the horse must undergo an extra clinical procedure. There is inherent variation in the product, and the cells cannot be injected immediately after an injury when they may be the most beneficial.

To allow the prompt treatment of a tendon injury and to improve the ability to standardise the product, allogeneic cells must be used. This means isolating the cells from donor horses and using them to treat unrelated horses. Experimental and clinical studies in horses, mice and humans suggest that this is safe to do with MSCs, and recently an allogeneic MSC product was approved for use in the EU for the treatment of joint inflammation in horses. These cells are isolated from the circulating blood of disease-screened donor horses and are partially turned into cartilage cells in the laboratory. They are then available off the shelf to treat unrelated animals. Allogeneic MSC products for tendon injuries are not yet available, but this would provide a significant step forward as it would allow horses to be treated immediately following an injury. However, MSCs exhibit poor survival and retention in the injured tendon and improvements to their persistence in the injury site, and with a better understanding of how they aid tissue regeneration, they are required to enable better optimised therapies in the future.

Our research has previously derived stem cells from very early horse embryos (termed embryonic stem cells, ESCs. Figure 2). ESCs can grow in the laboratory indefinitely and turn into any cell type of the body. These properties make them exciting candidates to provide unlimited numbers of cells to treat a wide range of tissue injuries and diseases. Our experimental work in horses has shown that, in contrast to MSCs, ESCs demonstrate high survival rates in the injured tendon and successfully turn into tendon cells. This suggests that ESCs can directly contribute to tissue regeneration.

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Outlook for stem cell therapy - its role in tendon regeneration - different treatments for horse tendon injuries - Trainer Magazine

Is the Pro-Life Movement on a Collision Course with the Coronavirus? – The Dispatch

Amid the news explosion that followed President Trumps COVID-19 diagnosis and brief convalescence earlier this month, there was a nugget you might have missed: The antibody treatment from biotech company Regeneron the president tookseemingly to great effecthad been developed in part by means of cells derived from fetal tissue.

Most of the discussion around this revelation concerned whether it showed the president to be a hypocriteeither personally because of his stated pro-life beliefs, or as a matter of policy because his administration has suspended federal funding for scientific research involving fetal tissue. (Both claims were dubious: There was no reason to believe the president knew the provenance of the Regeneron cocktail when he was treated with it, and the kind of fetal-derived cells used to develop the drug were not included in the administrations funding freeze.)

But the news portended a larger problem that may prove important in months to come: the ethical objections other pro-life people may have to new COVID treatmentsincluding vaccineswith similar issues in their development history.

I think its going to test our convictions about these things, said Dr. C. Ben Mitchell, a professor of moral philosophy at evangelical Union University and senior fellow at the Center for Bioethics & Human Dignity. Whether or not we are going to be consistent with our convictions.

Beyond the central aim of ending legal abortion, no issue has so united the pro-life movement over the last few decades as the push to prevent fetal and embryonic remains from being used in medical research. In the 2000s, the battle involved embryonic stem cell research: President Bush prohibited federal funding for research involving new embryonic stem cell lines in 2001, a policy President Obama reversed in 2009. More recently, the issue has been researchers use of fresh tissue from recent abortions, following activist David Daleidens 2015 expos on Planned Parenthoods practice of selling organs from aborted fetuses to medical research companies.

But while pushing for public policy changes and supply chain reforms to make researchers less reliant on ongoing abortions, pro-lifers have also struggled with a parallel issue on a more personal level: whether its permissible to make use of treatments developed via the use of fetal tissue that already exist. If abortion is evil, they ask themselves, then can I in good conscience allow myself to benefit from medicines that rely on the practice?

Such questions are complicated by the fact that, unlike the tissue research that has dominated pro-life policy space in recent years, many medical products in current use, including a number of childhood vaccines, have a connection to abortion that is distant and tenuous. The cell cultures used in developing such medicines are most accurately described not as fetal cells themselves, but as cells that are fetal-derived: Cells originally taken from an aborted fetus that have been cultivated to multiply freely ever since.

The most widely used of these cell lines date back to just a handful of abortions in Europe in the 1960s. The WI-38 cell line, which has been used to develop vaccines for rubella, rabies, measles, mumps, and various other diseases, is derived from the lung tissue of a fetus aborted in Sweden in 1962; The MRC-5 line, used to produce vaccines for Hepatitis A and polio, dates back to 1966. Other lines are used for other purposes: HEK293 cells, which are derived from fetal kidney cells isolated in the Netherlands in the early 1970s, can be used to create virus-like cells that arent able to infect humans. Researchers use these pseudoviruses to test new therapeutics without having to handle live virus themselves, reducing the need for extreme biosafety precautions in laboratory settings. (The aforementioned Regeneron made use of HEK293 cells in this way.)

These cell cultures wont reproduce infinitely, but saying so almost feels like a technicality: Descendants of the WI-38 and MRC-5 lines have been used to create hundreds of millions of doses of vaccines over the past half-century.

Going by any sort of costbenefit analysis, the use of these cell lines has been a force for good in the world. By making use of the remains of a bare handful of elective abortionsabortions that would have taken place whether or not researchers decided to use thema staggering number of people around the world have been spared the miseries of a whole host of wretched and deadly diseases.

But for those who advocate for decoupling from such practices, simply to use the language of cost and benefit in the first place is to give away the game. If thats the measure, they argue, its hard to see how you could oppose any promising medical research, even the most depraved: How can you weigh the suffering of a few unfortunates against the ongoing benefits to all humanity of curing a deadly disease?

These sorts of ethical questions arent the exclusive domain of the pro-life movement. What posture we ought to take toward ill-gotten medical research is a question that has long occupied bioethicists, given how much of the science underpinning our current understanding and practice of medicine was conducted in unethical waysoften even by the standards of their own time, and even more so by the more exacting standards of the present.

The classic example, of course, is the gruesome human experimentation carried out by Nazi doctors in concentration camps, but there are examples closer to home, too: black men in Alabama whose untreated syphilis was allowed to fester for decades so government researchers could observe the progress of the disease, all the while assuring the subjects they were being treated; developmentally disabled children in New York given chocolate milk laced with feces to deliberately infect them with hepatitis as part of an effort to develop a vaccine.

Other ethical issues involve the origin of immortalized cell cultures in particular. The longevity of these cell lines is such that many of them predate modern medical standards on ethical human research, which werent truly codified until the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research, established by Congress for the purpose in 1974, published its Belmont Report in 1979. The oldest such cell line in existence is a culture of cervical cancer cells taken from a woman named Henrietta Lacks in 1951, who died of the disease that same year. Lacks never consented to having her cells cultured; nor did the women who obtained the abortions that resulted in the WI-38 or MRC-5 cells.

These fraught ethical issues are not a thing of the past. After decades of lobbying, the Lacks family finally won a partial concession from the National Institutes of Health in 2013 to place some restrictions on medical access to information about their relatives cells. Pro-life organizations continually push for researchers to divest from and seek alternatives to fetal cell cultures as well.

For some pro-life bioethicists, the vast distance between the harm of the original abortion and the use of the modern treatment in which it resulted means that, while policymakers and biotech firms still have a moral obligation to work toward developing ethically unproblematic alternatives, individuals dont necessarily have a moral duty to abstain from such treatments themselves. Medical ethics are complicated and a matter of conscience, said Tiffany Manor, who directs the Life Ministry of the conservative Lutheran ChurchMissouri Synod. Some modern medical procedures result from past research that was conducted unethically. That doesnt mean that we ought to throw out all of the beneficial procedures.

But others argue that individuals retain a moral duty to keep pressure on the medical research industry by declining the use of such treatments when possible without creating grave risks to public health. The Catholic Churchs Pontifical Academy for Life tried to strike such a balance when it considered the question in 2005:

On a cultural level, the use of such vaccines contributes in the creation of a generalized social consensus to the operation of the pharmaceutical industries which produce them in an immoral way. Therefore, doctors and fathers of families have a duty to take recourse to alternative vaccines (if they exist), putting pressure on the political authorities and health systems so that other vaccines without moral problems become available. They should take recourse, if necessary, to the use of conscientious objection with regard to the use of vaccines produced by means of cell lines of aborted human foetal origin.

The document goes on:

As regards the diseases against which there are no alternative vaccines which are available and ethically acceptable, it is right to abstain from using these vaccines if it can be done without causing children, and indirectly the population as a whole, to undergo significant risks to their health.

You can see the precarious moral tightrope here: It is good, in the mind of pro-life ethicists, to attempt as much as possible not to participate, however indirectly, in the evil act of a long-ago abortion. But one ought not strain so hard to avoid that participation that one thoughtlessly commits another evil act: allowing oneself or ones children to become vectors of otherwise preventable disease, spreading suffering and even death to those around them.

All this, remember, is just the moral calculus that surrounds such vaccine under normal medical circumstances. Throw in a global pandemic and an unprecedented race to treat and cure it, and you begin to get a sense of the scale of the ethical headaches involved.

Take the issue of Regeneron. Since his own positive experience with the companys antibody cocktail, REGN-COV2, President Trump has become its biggest cheerleader; pushing for it to play a major role in COVID treatment going forward. We have hundreds of thousands of doses that are just about ready. I have emergency use authorization all set, he said on October 7. Youre gonna get better, and youre gonna get better really fast.

But both Regenerons drug and a similar antibody treatment currently being developed by Eli Lilly made use of fetal tissue in their developmentnot in the actual manufacture of the drug, as mentioned above, but in creating neutered pseudoviruses to test its effectiveness.

Imagine a person whose doctor has recommended such a drug trying to make a decision in the light of the moral principles suggested by the Pontifical Academy for Life. On the one hand, the drug is a product of fetal tissue research in only the most remote possible way. But the possibility of endangering others by abstaining does not bear considering here, as the cocktail is a treatment, not a vaccine. Further, it is unclear how a person recommended such a treatment by a doctor ought to think about the question of whether there are ethically acceptable alternatives. Other drugs can help manage COVID, of course, but generally speaking their effect is cumulative: Dexamethasone and remdesivir are not replacements for antibody therapy.

To cap the dilemma off, it isnt as though a pro-life person could start off with unproblematic treatments and work up to REGN-COV2 as a matter of last resort: Patients arent prescribed antivirals or steroids for COVID unless theyre already seriously sick, while antibody treatments like Regenerons have been shown to be helpful only if theyre given very early in the course of the disease, before the bodys own immune response has had a chance to kick in.

COVID vaccines in development present further difficulties. First, we dont actually know which of the many vaccines currently being developed will end up the first to pass muster as a safe, effective, and mass-producible weapon against the pandemic. Many of the candidates do not make use of fetal-derived cells in any capacity. Others use such cells only in confirmatory tests, as with Regeneron. Still others use them in the production of the vaccines themselves.

Of the four vaccines seemingly closest to release in America, twothose being developed by Pfizer and Modernawere merely tested on fetal-derived cells. Two others, from Johnson & Johnson and AstraZeneca, are made with them. The latter vaccines Phase III clinical trials were placed on hold earlier this month, but were resumed last week.

Under ordinary circumstances, this would be a no-brainer: Many pro-life people would simply wait for one of the less objectionable vaccines to become available. But during the coronavirus pandemic, where every day that goes by without a vaccine is critical, what happens if Johnson & Johnson or AstraZenecas product is first past the post, and the federal government invests heavily in its development and distribution?

Its unclear whether such a situation would provoke a legal clash. The federal government doesnt have the constitutional authority to mandate vaccines, but states and cities can; all 50 states require children to receive a battery of vaccines before attending public school, although all offer various exemptions for religious, philosophical, and/or other reasons. Whether citizens have a right to such exemptions, however, is less clear: the Supreme Court has upheld mandatory vaccination programs in the past and has separately ruled that the right to practice religion freely does not include liberty to expose the community or the child to communicable disease.

Theres no reason to believe yet that states will choose to go that route. New York Gov. Andrew Cuomo, whose state was racked by the coronavirus this spring and who last year signed a state law ending religious exemptions for childhood vaccines, is thus far messaging that an eventual COVID vaccine will be available to all New York residents who want one.

The likelier scenario may be that such a clash will instead simply play out in the court of public opinion.

One of the nightmare scenarios Ive been thinking about is, say we get a safe and effective vaccine, and it comes from what many would regard as tainted sources, said Mitchell. And so pro-lifers decide not to use the vaccinethey wont be vaccinated. My guess is that there would be a huge uprising in the society saying, Well, youre posing now a public health risk. We now have a vaccine, but youre choosing not to use it. Youre exposing others to it by not taking the vaccine, or youre going to cost our health care system huge amounts of money in treating you when we have a vaccine that could prevent getting COVID-19, but you choose not to. So I think those are going to be an important test of our convictions.

Photograph by Paul Hennessy/NurPhoto/Getty Images.

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Is the Pro-Life Movement on a Collision Course with the Coronavirus? - The Dispatch

Stem Cell Therapy Market to Register Unwavering Growth During 2025 – The Think Curiouser

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Yale Health advises against large Thanksgiving gatherings; eastern Connecticut now considered a ‘hot spot’ – The Westerly Sun

Yale-New Haven physicians and infectious disease experts are recommending against large Thanksgiving gatherings as the number of COVID-19 cases increases in the hospital network's service area.

The Yale New Haven Health staff members, speaking during a news conference on Tuesday, said eastern Connecticut is currently a "hot spot" for the virus. At the time, L+M Hospital was treating 11 patients for COVID-19 and Westerly Hospital was treating six patients for the virus. Westerly's peak number of COVID-19 patients was eight patients on April 23.

"Human connection and family is so important, but at this point I just don't feel comfortable with a large gathering," said Dr. Thomas Balcezak, chief medical officer of Yale-New Haven Hospital.

Avoiding large groups, wearing a face mask, and social distancing are all advised to help slow the spread, Balcezak said.

"It is still very important to double down on these public heath measures like mask-wearing. We didn't know that it worked in the first part of this pandemic, but there is now scientific certainty that mask-wearing and social distancing work. There's no question about that," Balcezak said.

Some medical experts believe masks may also help reduce the amount of virus individuals are exposed to, leading to less serious infections, Balcezak said.

Doctors have also made strides in treating the disease, which may explain why patients seem to be experiencing less severe cases, Balcezak said. The improved treatment approaches include use of steroids, proning or placing patients on ventilators on their stomachs, better administration of oxygen therapies, and improved management of secondary infections, Balcezak said.

Models point to an increase in cases in the colder months, but it is unclear when the second wave of cases might peak, Balcezak said.

"The second wave can be worse than the first. That is certainly what they saw in 1918," Balcezak said, referring to the flu pandemic of 1918.

Balcezak urged individuals to get a flu shot, saying the medical community remains concerned that the current flu season will mix with the COVID-19 pandemic to overwhelm hospitals.

The use of masks may be necessary for the foreseeable future, Balcezak said, even if a vaccine becomes available, because some vaccines stop individuals from becoming sick but do not stop infection, meaning individuals who have been vaccinated could still potentially spread the virus.

"It may be that even though we have a vaccine, there will be a time when people will still be contagious," Balcezak said.

Dr. Onyema Ogbuagu, an infectious disease specialist, reviewed Yale Health's participation in vaccine trials, including one of a vaccine being developed by Pfizer Inc., which he said appears to "be somewhat in the lead" ahead of others that are also in clinical trials. The Pfizer vaccine is being tested on adults and children over 12. Some of the test patients have diabetes and other conditions that cause compromised immune systems, he said.

The Pfizer vaccine involves the use of embryonic stem cells, which were also used to test vaccines used to fight shingles and Rubella. The cell lines being used were generated years before the COVID-19 outbreak, Ogbuago said. If the Pfizer vaccine is approved by the federal Food and Drug Administration, it will be manufactured using "traditional materials," Balcezak said.

It is likely, Ogbuago said, that other vaccines that did not use embryonic stem cells will eventually be approved, he said.

Marna Borgstrom, CEO of Yale-New Haven Health System, acknowledged the work of the Yale Health system's employees.

"The staff is working incredibly hard and they are just so unbelievably dedicated," she said.

The Yale panel was asked about a recent comment by President Donald J. Trump, who suggested hospitals in the country have an incentive for inflating the number of COVID-19 caused deaths that occur in their facilities in order to receive additional funding.

"It is illogical, if we report deaths, to think that we are going to get more money for deaths. It is impossible to figure out why he said that, along with, probably, several other things," Borgstrom said.

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Yale Health advises against large Thanksgiving gatherings; eastern Connecticut now considered a 'hot spot' - The Westerly Sun

JadiCell Stem Cells Licensed by Therapeutic Solutions International for Brain Injury Significantly Increased Survival of COVID-19 Patients in Double…

OCEANSIDE, Calif., Oct. 28, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported today a publication from the University of Miami1, demonstrating intravenous administration of JadiCells results in a significant survival improvement in COVID-19 patients. The Phase 1/2 double blind, placebo-controlled trial treated 12 advanced COVID-19 patients with 100 million JadiCells intravenously at days 0 and 3, and 12 patients received placebo control. At 28 days 91% of JadiCell treated patients survived whereas only 42% of patients in the placebo group survived. There were no adverse effects associated with JadiCell administration.

"In July of 2019, we obtained an exclusive license for the use of JadiCells in treatment of chronic traumatic encephalopathy (CTE) and brain injury2. Since then we have been working diligently at developing an IND file for initiation of clinical trials" said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. "The data reported today strongly supports further clinical translation of JadiCells. Not only do these data support safety of intravenous administration, but also attest to the potent anti-inflammatory and regenerative effects of this unique stem cell population."

JadiCells are a type of "supercharged" mesenchymal stem cells which have been demonstrated by the Company, as well as independent academic and private institutions to possess superior therapeutic activity as compared to other stem cells.

"As a company, TSOI is highly interested in inflammatory processes associated with COVID-19, in fact, we are unique in being one of the only companies that is concurrently developing cellular therapies while running clinical trials on nutraceutical approaches to COVID-193" said Famela Ramos, Director of Business Development.

"It has been my pleasure to work with Timothy Dixon and his scientific team in advancing the basic science surrounding JadiCells, and the clinical translation for treatment of brain pathologies" said Amit Patel, MD, MSc, inventor of the JadiCell. "By supplying our cells to groups such as University of Miami, or Therapeutic Solutions International, we believe we can hyper accelerate the development of this novel stem cell, and hopefully save some lives."

"I applaud the brave doctors which have implemented the novel use of JadiCells in treatment of COVID-19. It is an honor to work with Dr. Patel in what we anticipate will be another success for this cell type in addressing areas of unmet medical needs" said Timothy Dixon, President and CEO of Therapeutic Solutions International. "Brain injuries and CTE take a terrible toll not only in our athletes, but also our soldiers and veterans, contributing to suicide and other pathologies. We are excited to utilize JadiCells in treating one of the last frontiers of medicine. the brain."

About Therapeutic Solutions International, Inc. Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3696875 2https://www.globenewswire.com/news-release/2019/07/01/1876699/0/en/Therapeutic-Solutions-International-2Obtains-Exclusive-License-for-Patented-Clinical-Stage-Adult-Stem-Cell-for-Treatment-of-Military-and-Sports-Brain-Injuries.html 3https://www.clinicaltrials.gov/ct2/show/NCT04421391

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JadiCell Stem Cells Licensed by Therapeutic Solutions International for Brain Injury Significantly Increased Survival of COVID-19 Patients in Double...

Impact Of Covid 19 On Adult Stem Cells Market 2020 Industry Challenges, Business Overview And Forecast Research Study 2026 – PRnews Leader

Overview for Adult Stem Cells Market Helps in providing scope and definitions, Key Findings, Growth Drivers, and Various Dynamics.

Adult Stem Cells Market Data and Acquisition Research Study with Trends and Opportunities 2019-2024 The study of Adult Stem Cells market is a compilation of the market of Adult Stem Cells broken down into its entirety on the basis of types, application, trends and opportunities, mergers and acquisitions, drivers and restraints, and a global outreach. The detailed study also offers a board interpretation of the Adult Stem Cells industry from a variety of data points that are collected through reputable and verified sources. Furthermore, the study sheds a lights on a market interpretations on a global scale which is further distributed through distribution channels, generated incomes sources and a marginalized market space where most trade occurs.

Along with a generalized market study, the report also consists of the risks that are often neglected when it comes to the Adult Stem Cells industry in a comprehensive manner. The study is also divided in an analytical space where the forecast is predicted through a primary and secondary research methodologies along with an in-house model.

Download PDF Sample of Adult Stem Cells Market report @ https://hongchunresearch.com/request-a-sample/92343

Key players in the global Adult Stem Cells market covered in Chapter 4: Intellicell Biosciences Inc. Globalstem Neurogeneration Capricor Inc. Caladrius Biosciences Inc. Mesoblast Ltd. Celyad Juventas Therapeutics Inc. Cytori Therapeutics Inc. Cellular Dynamics International Epistem Ltd. Brainstorm Cell Therapeutics Inc. Cellerant Therapeutics Inc. Hybrid Organ Gmbh Cellerix Sa Neuralstem International Stem Cell Corp. Beike Biotechnology Co. Ltd. Biotime Inc. Gamida Cell Ltd. Clontech

In Chapter 11 and 13.3, on the basis of types, the Adult Stem Cells market from 2015 to 2026 is primarily split into: Epithelial Stem Cells Hematopoietic Stem Cells

In Chapter 12 and 13.4, on the basis of applications, the Adult Stem Cells market from 2015 to 2026 covers: Neurodegenerative Diseases Heart Diseases Bone Diseases Others

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13: North America (Covered in Chapter 6 and 13) United States Canada Mexico Europe (Covered in Chapter 7 and 13) Germany UK France Italy Spain Russia Others Asia-Pacific (Covered in Chapter 8 and 13) China Japan South Korea Australia India Southeast Asia Others Middle East and Africa (Covered in Chapter 9 and 13) Saudi Arabia UAE Egypt Nigeria South Africa Others South America (Covered in Chapter 10 and 13) Brazil Argentina Columbia Chile Others

For a global outreach, the Adult Stem Cells study also classifies the market into a global distribution where key market demographics are established based on the majority of the market share. The following markets that are often considered for establishing a global outreach are North America, Europe, Asia, and the Rest of the World. Depending on the study, the following markets are often interchanged, added, or excluded as certain markets only adhere to certain products and needs.

Here is a short glance at what the study actually encompasses: Study includes strategic developments, latest product launches, regional growth markers and mergers & acquisitions Revenue, cost price, capacity & utilizations, import/export rates and market share Forecast predictions are generated from analytical data sources and calculated through a series of in-house processes.

However, based on requirements, this report could be customized for specific regions and countries.

Brief about Adult Stem Cells Market Report with [emailprotected]https://hongchunresearch.com/report/adult-stem-cells-market-size-2020-92343

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Adult Stem Cells Market

Chapter Four: Players Profiles

Chapter Five: Global Adult Stem Cells Market Analysis by Regions

Chapter Six: North America Adult Stem Cells Market Analysis by Countries

Chapter Seven: Europe Adult Stem Cells Market Analysis by Countries

Chapter Eight: Asia-Pacific Adult Stem Cells Market Analysis by Countries

Chapter Nine: Middle East and Africa Adult Stem Cells Market Analysis by Countries

Chapter Ten: South America Adult Stem Cells Market Analysis by Countries

Chapter Eleven: Global Adult Stem Cells Market Segment by Types

Chapter Twelve: Global Adult Stem Cells Market Segment by Applications 12.1 Global Adult Stem Cells Sales, Revenue and Market Share by Applications (2015-2020) 12.1.1 Global Adult Stem Cells Sales and Market Share by Applications (2015-2020) 12.1.2 Global Adult Stem Cells Revenue and Market Share by Applications (2015-2020) 12.2 Neurodegenerative Diseases Sales, Revenue and Growth Rate (2015-2020) 12.3 Heart Diseases Sales, Revenue and Growth Rate (2015-2020) 12.4 Bone Diseases Sales, Revenue and Growth Rate (2015-2020) 12.5 Others Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Adult Stem Cells Market Forecast by Regions (2020-2026) continued

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List of tables List of Tables and Figures Table Global Adult Stem Cells Market Size Growth Rate by Type (2020-2026) Figure Global Adult Stem Cells Market Share by Type in 2019 & 2026 Figure Epithelial Stem Cells Features Figure Hematopoietic Stem Cells Features Table Global Adult Stem Cells Market Size Growth by Application (2020-2026) Figure Global Adult Stem Cells Market Share by Application in 2019 & 2026 Figure Neurodegenerative Diseases Description Figure Heart Diseases Description Figure Bone Diseases Description Figure Others Description Figure Global COVID-19 Status Overview Table Influence of COVID-19 Outbreak on Adult Stem Cells Industry Development Table SWOT Analysis Figure Porters Five Forces Analysis Figure Global Adult Stem Cells Market Size and Growth Rate 2015-2026 Table Industry News Table Industry Policies Figure Value Chain Status of Adult Stem Cells Figure Production Process of Adult Stem Cells Figure Manufacturing Cost Structure of Adult Stem Cells Figure Major Company Analysis (by Business Distribution Base, by Product Type) Table Downstream Major Customer Analysis (by Region) Table Intellicell Biosciences Inc. Profile Table Intellicell Biosciences Inc. Production, Value, Price, Gross Margin 2015-2020 Table Globalstem Profile Table Globalstem Production, Value, Price, Gross Margin 2015-2020 Table Neurogeneration Profile Table Neurogeneration Production, Value, Price, Gross Margin 2015-2020 Table Capricor Inc. Profile Table Capricor Inc. Production, Value, Price, Gross Margin 2015-2020 Table Caladrius Biosciences Inc. Profile Table Caladrius Biosciences Inc. Production, Value, Price, Gross Margin 2015-2020 Table Mesoblast Ltd. Profile Table Mesoblast Ltd. Production, Value, Price, Gross Margin 2015-2020 Table Celyad Profile Table Celyad Production, Value, Price, Gross Margin 2015-2020 Table Juventas Therapeutics Inc. Profile Table Juventas Therapeutics Inc. Production, Value, Price, Gross Margin 2015-2020 Table Cytori Therapeutics Inc. Profile Table Cytori Therapeutics Inc. Production, Value, Price, Gross Margin 2015-2020 Table Cellular Dynamics International Profile Table Cellular Dynamics International Production, Value, Price, Gross Margin 2015-2020 Table Epistem Ltd. Profile Table Epistem Ltd. Production, Value, Price, Gross Margin 2015-2020 Table Brainstorm Cell Therapeutics Inc. Profile Table Brainstorm Cell Therapeutics Inc. Production, Value, Price, Gross Margin 2015-2020 Table Cellerant Therapeutics Inc. Profile Table Cellerant Therapeutics Inc. Production, Value, Price, Gross Margin 2015-2020 Table Hybrid Organ Gmbh Profile Table Hybrid Organ Gmbh Production, Value, Price, Gross Margin 2015-2020 Table Cellerix Sa Profile Table Cellerix Sa Production, Value, Price, Gross Margin 2015-2020 Table Neuralstem Profile Table Neuralstem Production, Value, Price, Gross Margin 2015-2020 Table International Stem Cell Corp. Profile Table International Stem Cell Corp. Production, Value, Price, Gross Margin 2015-2020 Table Beike Biotechnology Co. Ltd. Profile Table Beike Biotechnology Co. Ltd. Production, Value, Price, Gross Margin 2015-2020 Table Biotime Inc. Profile Table Biotime Inc. Production, Value, Price, Gross Margin 2015-2020 Table Gamida Cell Ltd. Profile Table Gamida Cell Ltd. Production, Value, Price, Gross Margin 2015-2020 Table Clontech Profile Table Clontech Production, Value, Price, Gross Margin 2015-2020 Figure Global Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Global Adult Stem Cells Revenue ($) and Growth (2015-2020) Table Global Adult Stem Cells Sales by Regions (2015-2020) Table Global Adult Stem Cells Sales Market Share by Regions (2015-2020) Table Global Adult Stem Cells Revenue ($) by Regions (2015-2020) Table Global Adult Stem Cells Revenue Market Share by Regions (2015-2020) Table Global Adult Stem Cells Revenue Market Share by Regions in 2015 Table Global Adult Stem Cells Revenue Market Share by Regions in 2019 Figure North America Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Europe Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Asia-Pacific Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Middle East and Africa Adult Stem Cells Sales and Growth Rate (2015-2020) Figure South America Adult Stem Cells Sales and Growth Rate (2015-2020) Figure North America Adult Stem Cells Revenue ($) and Growth (2015-2020) Table North America Adult Stem Cells Sales by Countries (2015-2020) Table North America Adult Stem Cells Sales Market Share by Countries (2015-2020) Figure North America Adult Stem Cells Sales Market Share by Countries in 2015 Figure North America Adult Stem Cells Sales Market Share by Countries in 2019 Table North America Adult Stem Cells Revenue ($) by Countries (2015-2020) Table North America Adult Stem Cells Revenue Market Share by Countries (2015-2020) Figure North America Adult Stem Cells Revenue Market Share by Countries in 2015 Figure North America Adult Stem Cells Revenue Market Share by Countries in 2019 Figure United States Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Canada Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Mexico Adult Stem Cells Sales and Growth (2015-2020) Figure Europe Adult Stem Cells Revenue ($) Growth (2015-2020) Table Europe Adult Stem Cells Sales by Countries (2015-2020) Table Europe Adult Stem Cells Sales Market Share by Countries (2015-2020) Figure Europe Adult Stem Cells Sales Market Share by Countries in 2015 Figure Europe Adult Stem Cells Sales Market Share by Countries in 2019 Table Europe Adult Stem Cells Revenue ($) by Countries (2015-2020) Table Europe Adult Stem Cells Revenue Market Share by Countries (2015-2020) Figure Europe Adult Stem Cells Revenue Market Share by Countries in 2015 Figure Europe Adult Stem Cells Revenue Market Share by Countries in 2019 Figure Germany Adult Stem Cells Sales and Growth Rate (2015-2020) Figure UK Adult Stem Cells Sales and Growth Rate (2015-2020) Figure France Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Italy Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Spain Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Russia Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Asia-Pacific Adult Stem Cells Revenue ($) and Growth (2015-2020) Table Asia-Pacific Adult Stem Cells Sales by Countries (2015-2020) Table Asia-Pacific Adult Stem Cells Sales Market Share by Countries (2015-2020) Figure Asia-Pacific Adult Stem Cells Sales Market Share by Countries in 2015 Figure Asia-Pacific Adult Stem Cells Sales Market Share by Countries in 2019 Table Asia-Pacific Adult Stem Cells Revenue ($) by Countries (2015-2020) Table Asia-Pacific Adult Stem Cells Revenue Market Share by Countries (2015-2020) Figure Asia-Pacific Adult Stem Cells Revenue Market Share by Countries in 2015 Figure Asia-Pacific Adult Stem Cells Revenue Market Share by Countries in 2019 Figure China Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Japan Adult Stem Cells Sales and Growth Rate (2015-2020) Figure South Korea Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Australia Adult Stem Cells Sales and Growth Rate (2015-2020) Figure India Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Southeast Asia Adult Stem Cells Sales and Growth Rate (2015-2020) Figure Middle East and Africa Adult Stem Cells Revenue ($) and Growth (2015-2020) continued

About HongChun Research: HongChun Research main aim is to assist our clients in order to give a detailed perspective on the current market trends and build long-lasting connections with our clientele. Our studies are designed to provide solid quantitative facts combined with strategic industrial insights that are acquired from proprietary sources and an in-house model.

Contact Details: Jennifer Gray Manager Global Sales + 852 8170 0792 [emailprotected]

NOTE: Our report does take into account the impact of coronavirus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.

As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.

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Impact Of Covid 19 On Adult Stem Cells Market 2020 Industry Challenges, Business Overview And Forecast Research Study 2026 - PRnews Leader

APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an Off-the-Shelf Allogeneic Stem Cell Product for the Treatment of…

October 28, 2020 20:08 ET | Source: APstem Therapeutics

Fremont, CA , Oct. 28, 2020 (GLOBE NEWSWIRE) -- APstem Therapeutics, Inc., a private biopharmaceutical company developing breakthrough stem cell therapies, today announced the completion of an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT). The meeting, which included CBER OTAT staff together with the APstem team, focused on the development plan for AP-Skin-01, a novel off-the-shelf allogeneic stem cell product derived from adult pluripotent stem cells (APSCs) for the initial treatment of diabetic ulcers.

Previous efforts to treat diabetic ulcers have been hampered by persistent inflammation, ischemia and delayed re-epithelialization, which together have posed an insurmountable challenge for drug developers. APstems proprietary stem cell technologies and unique attributes of APSCs may circumvent these obstacles. Preclinical results generated to date by APstem support the potential of AP-Skin-01 to treat difficult-to-heal diabetic ulcers by accelerating healing. AP-Skin-01 is designed to provide full skin structural reconstruction with less scar formation, promote angiogenesis and reduce inflammation during the repair process.

The INTERACT meeting we conducted with the FDA is an important first step in our development of AP-Skin-01. We considered the meeting to be very successful, with productive feedback from the FDA reviewers and strong alignment of APstems development approach for AP-Skin-01, said Dr. Min Hu, CEO and president of APstem Therapeutics. I would like to thank the reviewers from FDA CBER OTAT for their time and helpful guidance. We look forward to continuing our planned pre-clinical work into 2021.

Dr. Jane Lebkowski, APstems scientific advisor and an expert in the development of cell and gene therapies, added: The field of chronic diabetic wounds remains a critical unmet medical need in the expanding diabetic population worldwide. This new therapy has high potential to accelerate full skin regeneration. Therefore, we are grateful for FDAs positive feedback to accelerate the development of this product that could treat millions of patients.

INTERACT is the first available FDA interaction and is a key step in the pathway towards an Investigational New Drug (IND) application, the first regulatory step before experimental therapies may be tested in human clinical studies.

About APstem Therapeutics, Inc.

APstem Therapeutics is a biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing novel stem cell therapies. APstems breakthrough stem cell therapy platform using our unique APSCs can be applied to multiple indications, including skin (diabetic ulcers), liver, lungs, bone/cartilage, heart, neuron and other tissues. For more information, please visit http://www.apstemtx.com.

Fremont, California, UNITED STATES

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APstem Therapeutics Announces Successful FDA INTERACT Meeting Regarding AP-Skin-01, an Off-the-Shelf Allogeneic Stem Cell Product for the Treatment of...

Why Small Businesses Matter in Wilton (Reimagined): Interventional Orthopedics Connecticut – HamletHub

Small businesses matter - now more than ever. They are answering the call with innovation and determination like never before.

We hope you join us in supporting them by sharing their story far and wide and shopping local! We are thankful to Fairfield County Bank for their continued support and making this series possible.

Step insideInterventional Orthopedics Connecticut!

Three questions with Daniel Southern, founder ofInterventional Orthopedics Connecticut.

_____________________________________________________________________________

What do you want the community to know? Are there ways for the community to help you and other local businesses to prosper?

Interventional Orthopedics treats orthopedic injuries and arthritis in a novel fashion using your bodys own repair mechanisms.

The bodys repair mechanism is contained in the cells of your body, specifically small cells in your blood called platelets and cells that we get from your bones called adult stem cells. We take these cells, concentrate them, and place them back in the body via injections very precisely into areas of damage.

When this works, surgery is not necessary. We are repairing tendon and ligament tears, meniscal and rotator cuff tears with precise injections of highly concentrated cells that we take from a simple blood draw out of your arm.

There is no cure for arthritis but the work we are doing can stop the pain of arthritis and dramatically slow its progression to the point where patients who were told that their only option was joint replacement are living happily with their own joints intact following our treatment.

Are you offering any new products or ways for customers to purchase your products or services that are popular during this crisis?

We are offering telemedicine evaluations that keep you safe at home while we can do a full evaluation of your issues to determine if you are a candidate for treatment. This is most effective if you already have imaging of your painful hip, knee, neck, shoulder, or back. If that is the case, we can go over the film with you at a Zoom meeting and discuss treatment options. If not, we can order them for you and meet again remotely to discuss them.

Please share the ways your business is adapting to keep your customers and employees safe in addition to the standard guidelines

We are offering our patients several options for any procedures that we recommend that will keep them out of high-traffic institutions such as a hospital waiting room or operating room or large clinical practice. We do many of our straight-forward ligament, tendon, and joint injections in the office with oral sedation and local anesthetic. For more involved cases or if the patient prefers IV anesthesia, we use the Wilton Surgery Center downstairs with strict safety protocols including every patient tested daily for Covid.

Our clinic has instituted a Maximum Protection Zone for patient and employee safety. In addition to the standard masks and social distancing, we test staff weekly for Covid-19 to make sure you are not exposed by us. We allow only two patients in the clinic at a time, one in each exam room or one in a room and one in the waiting area. All the air is continuously filtered with HEPA rated filters to remove any airborne viral particles. The exam rooms are blasted with UV light for 15 minutes between patients, again, to kill any airborne or surface viral particles. All surfaces in the exam room and front desk area are wiped clean using a laboratory-grade disinfectant.

Interventional Orthopedics Connecticut is located at195 Danbury Rd. in Wilton -Whitlock Building (second building) Suite B220 (second floor). Visit Interventional Orthopedics Connecticut online here, and also make sure to check out their Facebook page as well!

Daniel Southern nominatesDynamic Edge Physical Therapy from Wilton!

HamletHub thanksFairfield County Bankfor making our Why Small Businesses Matter series possible!

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Why Small Businesses Matter in Wilton (Reimagined): Interventional Orthopedics Connecticut - HamletHub