Many stem cell clinics promise unapproved treatments: How to stay safe – NBC News

Google has cracked down on pervasive, predatory ads promoting sketchy medical treatments a move that could affect many of the hundreds of stem cell treatments advertised online.

At the end of October, the internet giant stopped accepting ads for unproven or experimental medical techniques, according to a statement from the company. Google is taking this step after seeing a rise in bad actors offering deceptive and untested treatments, the company said.

Stem cells came up this week during the senate confirmation hearing for the next head of the Food and Drug Administration on Wednesday.

"FDA has taken enforcement action, which it should, against stem cell clinics and manufacturers that might be misleading people," Sen. Lamar Alexander (R-Tenn.) said. "On the other hand, we have diabetes advocates who say regenerative medicine may restore pancreas or put out of business a heart transplant surgeon by restoring a heart. Will you commit to taking seriously the promise of regenerative medicine and stem cell medicines?"

Dr. Stephen Hahn, President Trump's nominee to lead the agency, replied that he would "certainly commit to that."

The number of stem cell clinics in the U.S. doubled every year from 2009 to 2014, according to a report in the journal Regenerative Medicine.

Major renowned medical centers such as the Mayo Clinic are researching stem cell therapies for conditions including arthritis and heart problems.

But as stem cell clinics not affiliated with medical centers proliferate, so have serious concerns. In 2017, the New England Journal of Medicine reported that three women were virtually blinded from unproven "stem cell" treatments that actually involved having fat injected into their eyes.

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That has brought increased scrutiny from the FDA, which in June won a court ruling allowing the agency to regulate treatments at the Florida clinic where the three women were harmed.

Stem cell products have only been approved for two uses by the agency: for blood cancers and certain immune disorders. That hasnt stopped some providers from claiming their stem cell treatments can "cure" a wide range of conditions, from macular degeneration to multiple sclerosis unapproved treatments that are not only not effective, but could pose serious health risks.

Stem cells are very young cells that can develop into specialized cells, such as blood cells, bone cells and brain cells. According to the FDA, stem cells have the potential to replace, repair, restore and regenerate other cells, and could possibly be used to treat a number of medical conditions.

The only stem cell-based products currently approved by the FDA consist of blood stem cells derived from umbilical cord blood. These products are usually used in patients with blood cancers, such as leukemia and immune disorders. For patients with blood cancers, for example, stem cells are used after chemotherapy to replenish the blood cells that were destroyed during the treatment.

However, other uses are being studied. There are currently more than 650 active clinical trials for stem cell procedures, looking at a myriad of conditions including kidney failure and Crohn's disease.

But the purpose of a clinical trial is to determine if a treatment works or if it's safe.

People should understand that they're trying something that could potentially have benefit, Dr. Peter Marks, FDA director of biologics, said. But we don't know that benefit is really there, which means that they should understand the risk.

We do our best to make sure people are safe when they're getting investigational products, Marks said. When a product is in a clinical trial, the FDA can monitor it to make sure its safe, he added.

For patients considering stem cell treatments, the FDA recommends asking a health care provider if the FDA has reviewed the treatment.

This also applies to stem cell treatments that use a person's own cells. You may be told that because these are your cells, the FDA does not need to review or approve the treatment. That is not true, according to the FDA website.

The FDA has given that road map on how to do it responsibly, said Dr. Shane Shapiro, medical director at the Mayo Clinics Regenerative Medicine Therapeutics Program in Jacksonville, Florida.

Shapiro also recommends going to a provider that has an expertise in the disease or injury that they are offering stem cell products to treat.

I think it is important to point out when we see a patient at Mayo, they are still seeing someone with the expertise of a physician that is a specialist in the disease they need help with, he said.

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Patrick Martin is an associate producer in the NBC News Health & Medical Unit.

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Many stem cell clinics promise unapproved treatments: How to stay safe - NBC News

Partnership aims to accelerate cell and gene therapy – Harvard Gazette

MIT Provost Martin A. Schmidt said sharing the risk among several institutions will not only make possible work that would be difficult for a single institution to tackle, it will also encourage collaboration that accelerates the process of moving discoveries from lab to patient.

MIT researchers are developing innovative approaches to cell and gene therapy, designing new concepts for such biopharmaceutical medicines as well as new processes to manufacture these products and qualify them for clinical use, Schmidt said. A shared facility to de-risk this innovation, including production, will facilitate even stronger collaborations among local universities, hospitals, and companies and ultimately, such a facility can help speed impact and access for patients. MIT appreciates Harvards lead in convening exploration of this opportunity for the Commonwealth.

Richard McCullough, Harvards vice provost for research and professor of materials science and engineering, who also helped lead the project, said although the centers activity will revolve around science and manufacturing, its true focus will be on patients.

The centers overarching goal will be improving patient care, McCullough said. This would occur both by speeding access to the essential, modified cells that patients in clinical trials await, and by fostering discoveries through collaborations within the centers innovation space. The aim is that discoveries result in whole new treatments or improved application of existing treatments to provide relief to a wider universe of patients.

Organized as a private nonprofit, the center will be supported by more than $50 million pledged by its partners. It will be staffed by a team of at least 40, experienced in the latest cell-manufacturing techniques and trained in the use of the latest equipment. Among its goals is disseminating badly needed skills into the Boston life-sciences workforce.

We have to be sure that we are constantly feeding the industry with talented people who know the right things, so personally, I am very excited about education programs, Ligner said. Initiatives like [this center] are essential to advancing the industry because they help organizations build on one anothers advances. For example, the full potential of cell and gene therapies will only be realized if we collaborate to address challenges, such as manufacturing, improving access, accelerating innovation, tackling cost issues, and then sharing our learnings.

The new center emerged from conversations with state officials, including Gov. Charlie Baker and Attorney General Maura Healey, and industry sector leaders about ways to bolster Massachusetts preeminence in life science research and medical innovation. Those conversations sparked a two-year consultation process at the invitation of Garber and Harvard Corporation Senior Fellow Bill Lee, that was coordinated with state officials and included representatives from industry, academia, venture capital, area hospitals, and government.

Cell and gene therapies have the potential to revolutionize the global health system. Recently, in Sweden, the first patient received cell therapy outside of a clinical trial. Its the start of an incredible time in the industry and in human health.

Emmanuel Ligner, president and chief executive of GE Healthcare Life Sciences

Called the Massachusetts Life Sciences Strategies Group, members reached out to regional experts beginning in 2017to discover what fields they considered most important and how best to support them. Cell and gene therapy rose to the top because of the considerable excitement generated by activity already going on, its potential to help patients, and its high potential for future growth and innovation. Also important were the opportunities to spread the high cost of these technologies across multiple institutions and, while so doing, capture the collaborative power of housing each player in the development chain within a single facility.

The centers board of directors will be comprised of Harvard, MIT, and industry partners Fujifilm, Alexandria Real Estate Equities, and GE Healthcare Life Sciences. Other members will include Harvard-affiliated teaching hospitals Massachusetts General Hospital, Brigham and Womens Hospital, Beth Israel Deaconess Medical Center, Boston Childrens Hospital, and the Dana-Farber Cancer Institute; as well as the Commonwealth of Massachusetts and life-sciences company MilliporeSigma.

When you look at the constellation of players coming together, you really have the best universities and the best teaching hospitals and the best corporate players all supporting it, McGuire said, which I think is a great opportunity.

The facility intends to provide researchers and emerging companies outside the consortium with access to excess material, though organizers said they expect it to be in high demand by center partners.

The centers boost to the areas cell and gene therapy endeavors comes early enough that it should help maintain leadership over places like California and China, which have made clear their interest in life-science research, McGuire said.

I think getting this early mover advantage is going to be huge [in] developing the technology and the know-how and, ultimately, the intellectual property around it, McGuire said.

For Sharpe, the ultimate payoff will come from using cancer immunotherapys checkpoint blockade and other cell and gene therapies to save and improve lives.

We are seeing long-term benefits in some patients whove received checkpoint blockade, Sharpe said. There are patients who are more than a decade out and are melanoma-free. I think that it really has transformed patient care, quality of life, and longevity. So Im optimistic that the more we learn, the more were going to be able to do to help patients.

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Partnership aims to accelerate cell and gene therapy - Harvard Gazette

Prestigious NY Cancer Center Will Spend $3.7M To Study Bogus Cancer Treatment – Forbes

Reportage in a Chinese medicine practice in Lyon, France Acupuncture session. (Photo by: ... [+] BSIP/Universal Images Group via Getty Images)

Sometimes I'm not sure whether the best response to pseudoscience is to ignore it, or to patiently try to explain why it's wrong, or to get mad.

This week I'm mad.

My anger and frustration was triggered bya tweetfrom Memorial Sloan-Kettering's Integrative Medicine account, shown here:

Image captured by the author

For those who don't know,Memorial Sloan-Kettering Cancer Centeris one of the world's leading cancer centers, both for treatment and research. If you are diagnosed with cancer, MSK is one of the best places to go.

But not everything at MSK is world class. Unfortunately, they have an"integrative medicine"center that offers a mixture of therapies ranging from helpful to benign to useless. One of their biggest activities is acupuncture, which they claim offers a wide range of benefits to cancer patients.

The MSK tweet shown here was boasting abouta new, $3.7 million studyfunded by NIH to study the effect of acupuncture on pain that cancer patients experience from chemotherapy and bone-marrow transplants.

Here's why I'm mad: cancer patients are extremely vulnerable, often suffering the most frightening and difficult experience of their lives. They are completely dependent on medical experts to help them. When a place like MSK suggests a treatment, patients take it very seriouslyas they should. But they really have no choice: a cancer patient cannot easily look for a second opinion, or switch hospitals or doctors. Even if they have the money (and cancer treatment is extremely expensive), switching hospitals might involve a long interruption with no treatment, during which they could die, and it might also involve traveling far from their home.

Offering these patients ineffective treatments based on pseudoscienceand make no mistake, that's what acupuncture isis immoral. Now, I strongly suspect that the MSK's "integrative medicine" doctors sincerely believe that acupuncture works. Their director, Jun Mao, is clearly a true believer, as explained inthis profile of himon the MSK website. But that doesn't make it okay.

I've written about acupuncture many times before (here,here,here, andhere, for example), but let me explain afresh why it is nonsense.

Acupuncture is based on a pre-scientific notion, invented long before humans understood physiology, chemistry, neurology, or even basic physics, which posits that a mysterious life force, called "qi," flows through the body on energy lines called meridians. As explainedin this article by MSK's Jun Mao:

"According to traditional Chinese medicine ... interruption or obstruction of qi was believed to make one vulnerable to illness. The insertion of needles at specific meridian acupoints was thought to regulate the flow of qi, thus producing therapeutic benefit."

Today we know that none of this exists. There is no qi, and there are no meridians. In that same article, Jun Mao continued by admitting that

"the ideas of qi and meridians are inconsistent with the modern understanding of human anatomy and physiology."

And yet this is what they offer to patients at MSK.

Just to be certain, I readone of the latest studies from MSK, published early this year, which claims to show that acupuncture relieves nausea, drowsiness, and lack of appetite in multiple myeloma patients who were going through stem cell transplants.

It's a mess: totally unconvincing, and a textbook case of p-hacking (ordata dredging). The paper describes a very small study, with just 60 patients total, in which they measured literally dozens of possible outcomes: overall symptom score at 3 different time points, a different score at 3 time points, each of 13 symptoms individually, and more. I counted 24 different p-values, most of them not even close to significant, but they fixated on the 3 that reached statistical significance. The two groups of 30 patients weren't properly balanced: the sham acupuncture group started out with more severe symptoms according to their own scoring metric, andFigure 2in the paper makes it pretty clear that there was no genuine difference in the effects of real versus sham acupuncture.

But they got it published (in a mediocre journal), so now they point to it as "proof" that acupuncture works for cancer patients. This study, bad as it is, appears to be the basis of the $3.7 million NIH grant that they're now going to use, they say, in "a larger study in 300 patients to confirm these previous findings."

And there you go: the goal of the new study,according to the scientists themselves, is not to see if the treatment works, but to confirm their pre-existing belief that acupuncture works. Or, asone scientist remarked on Twitter, "they already have a result in mind, the whole wording of this suggests that they EXPECT a positive outcome. How did this get funded exactly?"

Good question.

So I'm mad. I'm mad that NIH is spending millions of dollars on yet another study of a quack treatment (acupuncture) that should have been abandoned decades ago, but that persists because people make money off it. (And, as others have explained in detail, acupuncture is actually a huge scam that former Chinese dictator Mao Zedong foisted on his own people, because he couldn't afford to offer them real medicine. For a good expos of Chairman Mao's scam,see this 2013 Slate piece.)

But I'm even more upset that doctors at one of the world's leading cancer centers are telling desperately ill patients, who trust them with their lives, that sticking needles into their bodies at bogus "acupuncture points" will relieve the pain and nausea of chemotherapy, or help them with other symptoms of cancer. I'm willing to bet that most MSK doctors don't believe any of this, but they don't want to invest the time or energy to try to stop it.

(I am somewhat reassured by the fact that MSK'sTwitter accounthas nearly 75,000 followers, while it's integrative medicine Twitter account has just 110.)

Or perhaps they are "shruggies": doctors who don't believe in nonsense, but figure it's probably harmless so they don't really object. To them I suggest this:read Dr. Val Jones's accountof how she too was a shruggie, until she realized that pseudoscience causes real harm.

And finally, let me point tothis study inJAMA Oncologyfrom last year,by doctors from Yale, which looked at the use of so-called complementary therapies among cancer patients. They found that

"Patients who received complementary medicine were more likely to refuse other conventional cancer treatment, and had a higher risk of death than no complementary medicine."

And also seethis 2017 studyfrom the Journal of the National Cancer Institute, which found that patients who used alternative medicine were 2.5 times more likely to die than patients who stuck to modern medical treatments.

That's right,Memorial Sloan-Kettering: patients who use non-traditional therapies are twice as likely to die. Thats why Im mad. This is not okay.

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Prestigious NY Cancer Center Will Spend $3.7M To Study Bogus Cancer Treatment - Forbes

Buckley family thank community for support as thousands sign up to be a stem cell donor in three weeks – LeaderLive

A BUCKLEY family has thanked the community for their support as they continue to search for life-saving treatment.

Matt Davies, from Buckley, beat cancer last year but now has 12 months to live without a stem cell transplant.

The Leader previously reported that wife Sarah was urging people to register to be a stem cell donor, which is a small process that can save the lives of many.

In just three weeks, over 1,000 people signed up through Sarahs link to be on the register.

She was also told that just under 6,500 people had signed up in total within the space of the three weeks.

She told the Leader: We havent heard anything about a donor for Matt, we are still waiting. We have an appointment on Monday, so fingers crossed they give us an update.

I was really shocked when I saw the response. Its obviously something we are plugging every day because its so serious, but we didnt think wed get anywhere near that amount.

I didnt even think there would be one thousand. Its really, really good and the response on social media with people sending in messages of support has been great.

People are seeing our story published and its really nice they are reaching out and showing support, even people we dont know. Its not a nice situation to be in.

Matt was diagnosed with cancer last year and beat it, however less than eight months later after having his routine bone marrow results he was told the leukaemia was back and his only option was a stem cell transplant.

Without it, he would not be here in the next 12 months.

Sarah added: It doesnt go unnoticed. I know its not a big deal swabbing your mouth, but it is in the end, you could end up saving someones life.

I do thank everyone and hope we have a positive outcome from it all.

So far we havent had a match but thats why we keep going. We arent going to stop.

Over 800 was also recently raised at a charity event which included cake sales and a raffle. All proceeds were donated to the Christie in Manchester where Matt is receiving his treatment.

Sarah said they have not told their young children that the bug is back but it is likely Matt will spend Christmas in the Christie in Manchester.

She said: The whole community has come together to support us, even people we dont know and we really do appreciate it.

Its quite scary. You read these things but never think its going to be you or someone you know. You never think it would affect you but it can.

Everyone has been amazing. Those who havent already, please just register. It can take seconds and you may not ever be called but if you are, you can save someones life by swabbing your mouth and giving blood.

Those wishing to see if they are eligible to be a stem cell donor can do so online at http://www.dkms.org.uk.

Matts journey can also be followed via Facebook and Instagram page team_davies_.

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Buckley family thank community for support as thousands sign up to be a stem cell donor in three weeks - LeaderLive

Join the stem cell registry – Berea Mail

Nicolene Moonsamy. Sheena Dhunlal and Stephanie Berry encourage people to attend the blood stem cell donor drive.

THE number of patients diagnosed with blood diseases is on the rise, with 75 per cent of those diagnosed under the age of 25 years.

For most of these patients, a blood stem cell transplant is their only hope of cure.

Lenmed Ethekwini Hospital and Heart Centre is partnering with The Sunflower Fund to host a blood stem cell donor drive on 27 November at 9.30am to recruit well informed and committed donors onto The Sunflower Fund Registry, The drive will take place in the auditorium on the fourth floor until 3pm.

Leukaemia, aplastic anaemia and immune deficiencies are among the few blood conditions that we treat in our practise and can be managed with a blood stem cell transplant. Stem cells make up the component that your immune system needs to function. During the transplant your body is rescued with an infusion of healthy blood stem cells, explained Dr Keshnie Moodley, treating specialist paediatrician and haematologist at KIDZCAN based at Lenmed Ethekwini Hospital and Heart Centre.

ALSO READ: Girls celebrate with The Sunflower Fund

The chances of finding this match is 1:100 000 and the best chance of a match is within your same ethnic background. There is only a 25 per cent chance that a sibling will be a match. The remaining 75 per cent chance depends on an unrelated matching donor being found. Patients of colour and mixed ethnicity around the world are at a disadvantage due to the under-representation of Black, Coloured, Indian and Asian donors in the global donor pool.

As such The Sunflower Fund proactively creates awareness and education about blood diseases as well as the process involved in becoming a blood stem cell donor. We remain a registry of donors that is representative of the people groups in our rainbow nation, who are willing to help anyone for whom they might be a match, said Stephanie Berry from The Sunflower Fund.

To attend the drive on 27 November, contact Xolani Hlongwane on 079 261 2664 or email: [emailprotected]

To become a blood stem cell donor, visit: http://www.sunflowerfund.org.

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Give someone a chance to live by joining the stem cell registry | Daily News – Independent Online

Durban - Every year individuals around the world are diagnosed with leukaemia and other life-threatening blood diseases.

For many, their only hope of a cure is a life-saving blood stem cell transplant. This is why the Sunflower Fund will be embarking on a blood stem cell donor drive which will be held on Tuesday to recruit donors onto their registry.

At least 75% of stem cell patients are under the age of 25 years, this is according to The Sunflower Fund - a scary fact and anyone is at risk of being diagnosed with a blood disease.

The Sunflower Fund spokesperson Xolani Hlongwane says that interested donors need to be between 18-45 and willing to help anyone.

Donors also need to weigh the constant weight of 50 and above, no chronic illnesses, no heart, brain or back surgery., he said.

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Give someone a chance to live by joining the stem cell registry | Daily News - Independent Online

Molecular Therapy Family of Journals Welcomes Roland W. Herzog and Gerhard Bauer as Editors-in-Chief – PR Web

It is important to understand that the Molecular Therapy family of journals offers unprecedented opportunities to publish high-quality articles in gene and cell therapy, Herzog says.

MILWAUKEE (PRWEB) November 25, 2019

The American Society of Gene & Cell Therapy (ASGCT) announced today the appointment of Roland W. Herzog, Ph.D. and Gerhard Bauer as editors-in-chief of the Societys field-leading journals, Molecular Therapy and Molecular TherapyMethods & Clinical Development, respectively. Both editors will begin their positions effective January 1, 2020.

Herzog, currently the editor-in-chief of Molecular TherapyMethods & Clinical Development, will assume the same role for a five-year term at Molecular Therapy from Seppo Yl-Herttuala, M.D., Ph.D. at the conclusion of Yl-Herttualas term. Herzog is also a professor of pediatrics, Riley Children's Foundation Professor of Immunology, and director of the gene and cell therapy program at Indiana University.

It is important to understand that the Molecular Therapy family of journals offers unprecedented opportunities to publish high-quality articles in gene and cell therapy, Herzog says. My vision has continued and even further strengthened close coordination and collaboration between the journal editors and partnership with Cell Press and ASGCT.

Bauer replaces Herzog at the helm of Molecular TherapyMethods & Clinical Development after serving as an associate editor of the same journal for more than four years. Bauer is an assistant professor of hematology and oncology and director of the Good Manufacturing Practice (GMP) laboratory at the UC Davis Institute for Regenerative Cures.

Over the years that I have been looking at manuscripts submitted to the journal, I have always loved the articles dealing with translational research, getting the products ready for clinical applications, improving their utility and solving problems in the manufacturing of these products, Bauer says. Now, at a time where we have clinical efficacy and also commercially approved cell and gene therapy products that save lives, it is even more important to strengthen the translational research field.

ASGCTs official journal, Molecular Therapy is the leading journal for research in the areas of gene transfer, vector development and design, stem cell manipulation, development of gene-, peptide-, protein-, oligonucleotide-, and cell-based therapeutics to correct genetic and acquired diseases, vaccine development, pre-clinical target validation, safety/efficacy studies, and clinical trials. Molecular Therapy is dedicated to promoting the sciences in genetics, medicine, and biotechnology. Publishing important peer-reviewed research and cutting-edge reviews and commentaries, the journal continues to attract the best material in the field. Molecular Therapy's 2018 impact factor is 8.402.

The aim of Molecular TherapyMethods & Clinical Development is to build upon the success of Molecular Therapy in publishing important peer-reviewed methods and procedures, as well as translational advances in the broad array of fields under the molecular therapy umbrella. Molecular TherapyMethods & Clinical Development's 2018 impact factor is 4.875.

In addition to Molecular Therapy and Molecular Therapy Methods & Clinical Development, ASGCT also owns and operates two other sibling journals, Molecular TherapyNucleic Acids (2018 impact factor 5.919) and Molecular TherapyOncolytics (2018 impact factor 5.710).

About ASGCTThe American Society of Gene & Cell Therapy is the primary professional membership organization for scientists, physicians, patient advocates, and other professionals with interest in gene and cell therapy. Our members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies. ASGCT advances knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease to benefit patients and society.

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Molecular Therapy Family of Journals Welcomes Roland W. Herzog and Gerhard Bauer as Editors-in-Chief - PR Web

Health: Botanix buddy set to benefit after DEA admits their synthetic CBD is probably ok – Stockhead

Following last months disastrous news that a cannabidiol (CBD) acne trial failed, Botanix (ASX:BOT) may win back doubters after convincing the DEA to de-schedule synthetic CBD.

The Drug Enforcement Agency (DEA) has removed the synthetic CBD made by Georgia-based Purisys from its druge schedule, and told the two companies on Friday it would no longer be scheduled as a controlled substance at all, because it could prove it effectively contains no THC.

Before now companies using synthetic or natural CBD needed licences from the DEA for all aspects of logistics and use, and cross-border transport was tightly controlled.

Stockhead understands this change is only for Purisys and is not an industry-wide shift in position from the DEA.

The company says the change will greatly reduce its costs.

The US drug law enforcer moved in late 2018 to re-schedule CBD generally from category 1 (in with cocaine and heroin) to category 5, meaning it considers the substance to have some medical benefit but is open to abuse.

Botanix signed with Purisys in October to supply all of the synthetic CBD it needs.

Also in October, Botanix said its acne trial failed: the 368 patient trial of BTX 1503 only worked for 40 per cent of cases, which isnt better than current non-CBD drugs on the market.

To be commercialised, drugs have to be better, not just the same.

Kazia Therapeutics (ASX:KZA) may be able to give glioblastoma (brain cancer) sufferers three more months of life with its drug, but cant be completely sure yet because thats based on data from the first eight patients with viable data, in a 29-patient phase two clinical trial. They do not yet have an overall survival rate.

Cynata (ASX:CYN) has applied for permission to start a phase two trial on critical limb ischaemia, a disease that involves the narrowing of arteries in the limbs. It generally results in amputations and is a risk factor for heart attacks. The company wants to test its Cymerus mesenchymel stem cell treatment on it.

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Health: Botanix buddy set to benefit after DEA admits their synthetic CBD is probably ok - Stockhead