Dr. Duncan Stewart

02
May 2017
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Dr. Duncan Stewart: "Be wary of any stem cell therapy that is fee-based and has not been validated through a complete clinical trial process."

More doctors treating aching joints with stem cells, even though treatment is costly, unproven and relief is only temporary

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It’s expensive, only temporary and lacks gold-standard proof that it actually works, but stem cell therapy for bad knees, hips and shoulders is taking hold in Canada.…

It’s expensive, only temporary and lacks gold-standard proof that it actually works, but stem cell therapy for bad knees, hips and shoulders is taking hold in Canada.

“The future is obviously injections of biologics,” says Dr. Tim Dwyer, an orthopedic surgeon at Women’s College Hospital in Toronto who has treated 20 patients’ faulty joints with stem cell injections at his private clinic. “One day we will look back and think joint replacement was a fabulous solution 30 years ago that now is quite a barbaric approach.”

We have written about these autologous (using a patient’s own stem cells) transplants in this space before. The first type, bone marrow aspirate concentrate (BMAC) therapy, involves extracting stem cells from a patient’s pelvis and spinning them in a centrifuge before re-injecting the refined cells in the damaged joint. The second type, formally known as stromal vascular fractioning, involves removing adipose (fat) cells via liposuction, running them through a centrifuge to collect the stem cells and re-injecting them in the patient’s ailing joint. Both are usually done on a same-day outpatient basis.

Neither treatment has been proven effective in large scale, randomized controlled clinical trials in which one group of patients gets the treatment and another gets a placebo — with neither group (nor the researchers conducting the trial, for that matter)  knowing who got what until the data is collected and analyzed.

“That is correct, not at this stage,” says Dr. Dwyer. “We’re basing (the use of the treatment) on cohort studies looking at BMAC in the knee especially.”

Dr. Jas Chahal, a colleague of Dr. Dwyer’s at Women’s College Hospital, believes there is “good basic science,” to support the use of stem cell treatments for knees, hips and joints afflicted by osteoarthritis or damaged by injury. “BMAC has various factors in it that probably help inflammation and pain control. There is emerging clinical evidence in the form of case studies, groups of 10 or 20, who have had it and after 12-month follow-up had good results.”

However, Dr. Duncan Stewart, the President and Scientific Director of the Ontario Institute for Regenerative Medicine, says patients “should be extremely wary of any stem cell therapy that is fee-based and has not been validated through a complete clinical trial process.

“Clinical trials exist to establish not just whether a treatment will work, but to ensure it is safe for the patient,” says Dr. Stewart, CEO of the Ottawa Hospital Research Institute and a leading authority on stem cells who has led or collaborated on more investigator-initiated cell therapy trials than anyone else in Ontario. “There are many promising stem cell therapies out there that are currently in clinical trials, but not all will approved for clinical use – and the only way we can know for sure is by collecting the proper data through a clinical trial that has regulatory and ethical approvals.”

For Dr. Dwyer, who sees the BMAC treatment as more effective but will provide the adipose-derived stem cell treatment for patients for whom BMAC isn’t appropriate, stem cell injections offer an option where none existed before.

“For 10 years of my career I’ve had to say ‘You’re too young to have a knee replacement and a knee scope won’t make you better, so there’s nothing we can do.’ That’s not a fun conversation to have three or four times a day.”

He charges between $3,000 and $3,500 per injection, none of which is covered by the provincial health insurance plan or by private insurance.

Some researchers and clinicians have taken things a significant step further by taking the BMAC cells and, instead of just running them through a centrifuge, culturing them in a lab to vastly increase the number of stem cells they can re-inject into the patient at a later date. But these treatments are significantly more expensive. Dr. Chahal is part of a team conducting a clinical trial extracting the mesenchymal bone marrow stem cells from patients and doing this kind of ex-vivo expansion and then re-injecting them at concentrations of 1 million, 10 million and 50 million cells. Researchers are currently collecting the data.

Of the 20 patients Dr. Dwyer has treated with the same-day therapy, “a couple” saw no improvement in their conditions. Most report feeling better. “Just yesterday I saw three people — two shoulders and a knee — and they were actually ecstatic. Now that’s just a cohort. But it certainly helped those people and they’re at the six-month mark.”

He points out that joint replacements are also not a sure thing.

“It’s not guaranteed that a knee replacement will help. Some 20% of people still have pain afterwards. And there’s always the chance that you get an infection, which can be a disaster. A lot of people, including myself, think that joint replacement is a last resort. So, obviously, having an injection that might take the pain away for a year is a very attractive option.”

Pain relief, if achieved, likely will be only temporary, says Dr. Dwyer. “We’re looking at a year,” says Dr. Dwyer. “For some people it will be more, for some it will be less. It will be something that you will need to have repeated. But if you ignore the financial cost of it, which is a significant factor obviously, and just look at whether you would like to have an injection once a year and not have a knee or a hip replacement, the answer is easy.”

BMAC and adipose stem cell treatments for arthritic and damaged joints have been around for about a decade and are widely available across the United States, with many Canadians travelling there to undergo them, sometimes paying exorbitant fees.

Here at the Canadian Stem Cell Foundation, we get more patient enquiries and blog comments about stem cell treatments for failing joints — be it from either osteoarthritis or injury or overuse — than any other single condition. People are both intrigued and suspicious and are looking for guidance.

What is Health Canada’s position on the use of bone marrow aspirate concentrate injections/transplants to treat knees and hips?

The Office of Policy and International Collaboration at Health Canada’s  Biologics and Genetic Therapies Directorate  responded by email to say that “in some cases, autologous cell therapy products that are processed for a particular patient by a regulated health professional pursuant to the scope of their practice may not require federal pre-market regulatory authorization under the Food and Drug Regulations. They added that, based on the information we provided, “we do not have enough information to make a determination regarding the regulatory pathway that would apply to BMAC.”

Prof. Leigh Turner, a Canadian who is an Associate Professor at the University of Minnesota’s Centre for Bioethics, has followed the proliferation of clinics offering BMAC and adipose treatments in the United States. He says it’s “premature” for Canadian orthopedic surgeons and other physicians to charge for “so-called stem cell treatments” administered to patients with joint problems.

“Safety and efficacy of such interventions still needs to be evaluated in carefully designed and properly conducted randomized controlled trials,” says Prof. Turner. “Such studies will have to address whether stem cells obtained from BMAC, adipose tissue, or other sources are optimal when treating patients with osteoarthritis. Carefully designed clinical trials should also provide meaningful information about dosing strategies, optimal mode of administering cells, and the frequency with which injections will need to be provided.” And all that, says Prof. Turner, is conditional on stem cell interventions beating placebo during the randomized controlled trial process.

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29
Nov 2016
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Stem Cell Network’s $9 million awards will advance research into new treatments

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Unveiling its 2016 funding awards last week, the Stem Cell Network announced support for six clinical research trials for new cell-based treatments.…

Unveiling its 2016 funding awards last week, the Stem Cell Network announced support for six clinical research trials for new cell-based treatments.

“The regenerative medicine research sector is fueled by stem cells and today it is at a tipping point, with the potential to see breakthroughs in our generation,” said Dr. Michael Rudnicki, Scientific Director of the Stem Cell Network.

One of the big winners was Dr. Lauralyn McIntyre, a researcher/clinician at The Ottawa Hospital and a professor at the University of Ottawa.  Her team receives $1 million of the $9 million in announced funding to conduct a cross-Canada Phase 2 clinical trial of mesenchymal stem cell therapy for septic shock.  We profiled her work on the deadly condition here

Her colleague at The Ottawa Hospital, Dr. Duncan Stewart, will use his $999,546 award to advance his work testing enhanced angiogenic cell therapy for acute heart attacks.  Check out Dr. Stewart’s Q&A here.

As well, Dr. Sandra Cohen at the Hôpital Maisonneuve Rosemont in Montreal will investigate ways to improve the expansion of cord blood hematopoietic stem cells via her $999,968 award.

Two diabetes trials were also funded: Dr. Timothy Kieffer of the University of British Columbia gets $500,000 to test a stem cell therapy for insulin replacement, while Dr. James Shapiro of the University of Alberta receives almost the same amount for a clinical trial to solve the “supply and survival problem” in using stem cell transplants.  Both Dr. Kieffer and Shapiro also receive $500,000 in funding through the Network’s Disease Team Program.

In all, 31 projects from across Canada will receive funding to help move research from lab bench to bedside in areas such as brain injury, kidney disease and breast cancer.

Making the announcement, Science Minister Kirsty Duncan said the investment will help translate discoveries into better health and economic growth for Canadians.  It was made possible with the announcement of a two-year, $12-million extension of the Stem Cell Network in the March federal budget.

In a news release, Dr. Stewart said the funding “brings us a big step closer to figuring out how to harness the incredible potential of stem cells to treat devastating diseases.”

 

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20
Jul 2016
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Dr. Duncan Stewart

Q&A with Duncan Stewart, new head of the Ontario Institute for Regenerative Medicine

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Dr.  Duncan Stewart is one of the busiest people in regenerative medicine in Canada.  An internationally respected cardiac specialist, he leads a three-city clinical trial investigating the potential benefits of genetically enhanced stem cells in healing severe heart attacks. …

Dr.  Duncan Stewart is one of the busiest people in regenerative medicine in Canada.  An internationally respected cardiac specialist, he leads a three-city clinical trial investigating the potential benefits of genetically enhanced stem cells in healing severe heart attacks.  He also heads research at The Ottawa Hospital and teaches at the University of Ottawa.  Dr.  Stewart was recently named President and Scientific Director of the Ontario Institute for Regenerative Medicine (OIRM).

Q: Along with your research, clinical work and teaching, you’ve now taken on the role of Scientific Director for OIRM.  How do you juggle it all?

A: It’s a matter of prioritization.  My day job is here at the Ottawa Hospital Research Institute (OHRI) and that’s a fairly significant operation because we’re one of the largest in Canada now.  I have a wonderful team here; it’s well set up and it can be done reasonably.

My clinical practice is really a hobby right now.  I see patients in a clinic that specializes in what I’m interested in: pulmonary hypertension and serious cardiac heart problems.  It’s personally rewarding; it keeps me sane and I can do something where I think I’ve made a difference.  But it’s about a half-a-day a week.  I don’t do much teaching … two or three or four courses a year.

I love doing research.  I thought that when I took on these other responsibilities maybe I’d have to reduce that, but I’ve been successful at getting funding and the projects have been successful, so it’s larger.  It’s aligned with the other things I do.  The priorities of the OHRI are well aligned with the kind of research I do and the new opportunity with the OIRM, again, is very aligned.

Q: What are you excited about in the field of stem cells and regenerative medicine?

A: I’m excited about moving it more into the clinic.  But we have to be realistic about the expectations.  When we’re doing these clinical trials, we are doing them to learn.  There are all kinds of issues we have to get right in order to unlock the real potential of these therapies.  It’s going to take a fair bit of work and a number of clinical trials and going back to the bench to refine approaches before we get to the point where we can do the dramatic things we hope to do.

If you look at the pace of development for other disruptive technologies, in the early stages they didn’t look that fantastic.  It’s similar to the early days of the personal computer.  It was very frustrating.  You did it for fun, really, for word processing, but it was hardly earth-shaking.  Now you look at a PC and it can do what NASA used to do with a great big mainframe.  A smartphone can do absolutely everything.  The technology has evolved to the point where it’s changed the whole landscape.

I think that’s true also in the cell and gene therapy space.  When I look at what’s going on in our lab and what’s going on globally, there is so much opportunity to advance this and improve the sophistication.  The potential is just huge.  What we’re doing in clinical trials, because we’re doing things that are well-tested and safe, tends to be using technologies that were developed 10 years ago.  So it’s well behind the cutting edge of where the field is going.  It takes that much time to get to clinical trials.  I think what we’re looking for is more proof of principle, where we can — in a modest way — achieve some of our goals and learn where the opportunities are to make things better.

Q: So the key is to move into clinical trials?

A: It’s important even when you’re at the early stages of development of technologies, in a safe and responsible way, to get the experience in the context of the patient population that has the disease.  Because you can never model all this completely in the lab.  You may have a great technology, but unless you can use it in the real world patient population you could have a problem.

A good example is autologous cell therapy (therapies in which the patient’s own stem cells are used).  For the chronic diseases we want to treat with regenerative approaches, we’re usually dealing with older patients who have risk factors and various diseases.  All that reduces their regenerative activity of their own cells: their stem cells aren’t very good.  So, you can do all the testing you want in young, healthy models but you’ve got to get at that problem.  We need to find why these cells don’t work and what we can do to recover activity.  Induced pluripotent stem cell technology (drawing cells from skin and reprogramming them back to an embryonic stem cell-like state) not only produces a pluripotent stem cell, it turns the age back to zero.  There are other issues with that in terms of safety and whether it’s ready for prime time, but there are already clinical trials starting with that technology.  That’s one way.  There are other ways, maybe more subtle ways, to recover regenerative activity.  These are the issues that come to the fore when you start to translate therapies into clinical trials.

Q: There is some frustration that things haven’t moved faster.  Stem cells have been touted as being able to cure a number of diseases and that it’s going to happen soon.  What’s holding the field back?

A: The frustration is probably our own doing: we bought into the hype or generated the hype too much.  We need to set the expectations at a realistic level.  It does no good to say we’re going to cure a disease with an approach when we’re not really there yet.  It’s important that we do the clinical trials.  It’s important to understand what benefit we get, if any, with a simple, early therapy so we can start improving it.  But we need to understand that this is going to be a somewhat incremental process at the beginning.  It’s not going to be earth-shattering and necessarily curative in the first iteration.  Setting that expectation will decrease that frustration.

The reality is, this takes time.  It’s a very different activity to be moving these approaches into clinical trials than doing the fundamental research.  People who have made major discoveries are not necessarily equipped or have the ability or interest to move them into clinical trials.

What does work well is a team approach.  You have the innovative scientist who makes the discovery as an important part of that team.  But a lot of what has to be done to translate that into a clinical trial is the preclinical research needed for regulatory submissions — which is not the exciting kind you publish in Nature.  It’s a different skill set than is normal in a discovery lab.  And you need people who understand the disease and where the therapy should best be targeted.  You need people who understand what kind of trial needs to be done to get the right answers.  It takes a lot of people who have complementary expertise who come together in a translational research program and say ‘OK, we think this is potentially going to make a big difference.  This is how we’re going to move it forward in a safe, responsible and effective manner.’ Coincidentally, this is exactly what OIRM is doing, funding these team grants to develop translational teams.

Q: What do you see as OIRM’s role?

A: Ontario is a big player in Canada in this space.  We’re not the whole story but were a big part of the story.  There is tremendous talent.  What OIRM can do is help people understand how to move this forward, how to build these teams.  It’s education: bringing in experts who have had success and helping these teams move forward, helping them build in the areas where they need to build.  It’s not always intuitive.  I see OIRM as a real catalyst.  It also has a role to shepherd these activities in the right direction so there’s the greatest chance of success.

 

 

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25
May 2016
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Dr. Duncan Stewart: "Be wary of any stem cell therapy that is fee-based and has not been validated through a complete clinical trial process."

Researcher/clinician Stewart to lead OIRM’s ‘next phase of growth’

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The Ontario Institute for Regenerative Medicine (OIRM) today named Dr. Duncan Stewart, one of Canada’s leading stem cell researchers, as its new President and Scientific Director.…

The Ontario Institute for Regenerative Medicine (OIRM) today named Dr. Duncan Stewart, one of Canada’s leading stem cell researchers, as its new President and Scientific Director.

“It will be my pleasure to serve OIRM by helping the organization, its researchers, trainees and staff to fulfill their passion to make a difference for all Ontarians,” Dr. Stewart said in a media release.

He succeeds Dr. Janet Rossant, who launched OIRM in 2014 but recently took on a new role as the Gairdner Foundation’s President and Scientific Director.  She praised Dr. Stewart “the perfect choice to lead OIRM as it moves into the next phase of growth.”

The head of research at The Ottawa Hospital and a professor at the University of Ottawa, Dr. Stewart co-leads an early stage clinical trial to test the use of stem cells to treat septic shock. It has shown promising preliminary results.  And he is conducting a Phase 2 trial to investigate the use of genetically enhanced stem cells to treat heart attack patients.

Dr. Stewart will remain in Ottawa to pursue his lab and clinical research activities and to carry on as Executive Vice-President of Research at The Ottawa Hospital.

“Given the breadth of his skills, Duncan brings unique perspectives on the regenerative medicine environment, particularly in the critical area of clinical trials and the development of new treatments, which is a key part of our mission,” said Sharon Colle, Chair of the OIRM Board and President and CEO, of The Foundation Fighting Blindness.

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27
Jul 2015
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Dr. Duncan Stewart (Ottawa Citizen)

‘It would be a shame for us to slide back’

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Canada is losing ground in the field it founded, says Dr. Duncan Stewart, one of the world’s leading stem cell scientists.…

Canada is losing ground in the field it founded, says Dr. Duncan Stewart, one of the world’s leading stem cell scientists.

“Generally, the pace (of funding) is slower and I think we are losing ground compared to other jurisdictions,” Dr. Stewart told the Ottawa Citizen’s Elizabeth Payne. “Canada has been a leader in this area. It would be a shame if we were to slide back.”

Dr. Stewart, Executive Vice-President of Research at The Ottawa Hospital,  recently published results of the world’s first clinical trial of a genetically enhanced stem cell treatment for pulmonary arterial hypertension, a deadly disease for which there is no cure. The  results are promising, but a larger study is needed to see if the new therapy can produce long-term results. The money to do it, however, just isn’t there.

As the Citizen article points out: “Just as the promise of potential new stem cell therapies is blossoming, research funding is more uncertain than ever.”

The reality is Canadian researchers are poised to deliver new cures for devastating conditions like diabetes, heart disease, cancer, autoimmune disorders like MS and Crohn’s, and neurological conditions like Parkinson’s, stroke and spinal cord injury. But it will take a coordinated effort to make that happen.

Our Foundation leads the coalition of researchers, medical professionals, health charities, industry leaders and philanthropists behind the Canadian Stem Cell Strategy & Action Plan. A bold private/public partnership, it would see Canada lead the way in delivering up to 10 new curative therapies within 10 years.

 

 

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13
Jan 2015
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Howe treatment points to need for Strategy

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The”miraculous” recovery of the Canadian hockey legend Gordie Howe, who suffered a severe stroke in October, made news across the country — and raised many questions.…

The”miraculous” recovery of the Canadian hockey legend Gordie Howe, who suffered a severe stroke in October, made news across the country — and raised many questions.

gordie howe

In mid-December, the star of Detroit Red Wings, received an experimental stem cell treatment in Mexico.

Howe’s son Mark told the Detroit Free Press that his father’s health has significantly improved since then. “His mobility was limited to shuffling his feet forward while sitting in a wheelchair. Within the past few days dad was pushing a cart at a grocery store, and he’s gone to the mall.” he said.

But what is the other side of Howe’s fast resurgence? Was the procedure safe? Does it send out the wrong message?

The scientific validity of the procedure Howe underwent is unclear. According to the newspaper U-T  San Diego Howe received the treatment from Novastem, a Mexican stem cell company, at a clinic in Tijuana. San Diego’s Stemedica, which provided the stem cells, says it follows U.S. law and requires those licensing its stem cells in foreign countries to obey the laws of those countries.

Regardless, over the last years the much publicized potential of stem cells has raised hope among patients suffering from chronic diseases. This, in turn, has led some less than scrupulous companies across the globe to  capitalize on that hope by marketing costly stem cell therapies — often for a wide variety of diseases — without the support of proven clinical evidence.

Canadian scientists and medical ethics experts have warned that this phenomenon of stem cell tourism is on the rise and so are its risks.

As reported in Ottawa Citizen this morning, Howe is one of many Canadians who put themselves in danger by seeking experimental stem cell therapies in countries with softer regulations than in Canada.

“Patients go to places that offer stem cell therapies because they are looking for hope. And stem cells can offer that hope. Unfortunately, very often there is no proven benefit.” Dr. Duncan Stewart, chief executive and financial director of the regenerative medicine program at the Ottawa Hospital Research Institute told the Ottawa Citizen.

In past posts, Prof. Timothy Caulfield, Canada Research Chair in Health Law and Policy at the University of Alberta and a member of the Foundation’s Science Leadership Council, has said that unproven treatments create health risks for patients and undermine the credibility of stem cell research.

On this note, James Price, President and CEO of the Canadian Stem Cell Foundation, told the Citizen  that “stem cell tourism should be a wake-up call that Canada needs to prioritize funding for stem cell therapies.” He says it illustrates the need for the Stem Cell Strategy & Action Plan, which has a goal of leading the way to developing five to 10 new treatments to the clinic within 10 years.

As reported in the Citizen story, “A major emphasis of the stem cell Action Plan, which includes public and private funding, is giving Canadians confidence that new therapies are a priority and ultimately, Canadians will have first access to these therapies.”

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25
Mar 2014
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Tiny hearts = big deal for drug testing

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When the subject of using stem cells to treat disease comes up, most of us have an image of doctors injecting or infusing these building-block cells into a patient to stimulate the repair of their traumatized tissue or dysfunctional organs.…

When the subject of using stem cells to treat disease comes up, most of us have an image of doctors injecting or infusing these building-block cells into a patient to stimulate the repair of their traumatized tissue or dysfunctional organs.

We’ve written about this approach several times in this space — most recently reporting on a clinical trial to test stem cells in spinal cord injury.  We also reported on a 100-participant study led by Dr. Duncan Stewart at the Ottawa Health Research Institute infusing genetically enhanced blood stem cells into damaged hearts to generate healthy tissue, minimize scarring and prevent heart failure.

Those kinds of studies are called in vivo, meaning “within the living.” But researchers are also opening up entirely different front in the war on disease: using stem cells to create “models” of diseased tissue or organs for testing drugs. Called in vitro (literally, “within the glass” to signify experiments carried out in a Petri dish or test tube), these studies essentially set up a disease straw man for a potential therapy to knock down.

There are advantages to this approach: it skips the pre-clinical animal testing stage that can be a labour-intensive, time-consuming exercise. Imagine the frustration of spending months testing a new drug on rats only to find it’s a no-go. Also, what can show great promise in testing with genetically engineered, immuno-suppressed rats often doesn’t translate into something that will work on real, live, normal human beings.

One of the more promising examples of this kind of work is underway at the University of Toronto’s Institute of Biomaterials & Biomedical Engineering and the McEwen Centre for Regenerative Medicine. Researchers there have developed the first-ever method for creating living, three-dimensional human heart tissue that behaves just like the one pumping blood through your body as you read this. Their findings were published in the Proceedings of the National Academy of Science recently and, so far, have been picked up by 10 media outlets.

“It means basically having hundreds of small versions or models of hearts in one dish, which we can test drugs on to determine which one actually has positive effects,” explains Nimalan Thavandiran, a PhD student in the labs of Drs. Peter Zandstra and Milica Radisic, and lead author of the study.

The ultimate goal, he says, is to create a heart micro tissue that is healthy and then “artificially apply an insult to it” to make it more like a diseased heart. These damaged micro hearts can then be treated with drugs — some that are already on the market for treating other conditions — to see which ones are helpful.

The micro heart tissue can also do service to test the cardio-toxicity of drugs used to treat other conditions. “Often times, a drug to treat cancer will make it to the later phases of a clinical trial and then fail because of side effects on either liver or the heart. So this is why it is important to have human cell-based models, like cardiac or liver models to see early on if these drugs have any adverse effects. And if they do, you can do two things: you can either scrap the drug or you can actually figure out how to molecularly modify it to prevent the toxic effect.”

In the extremely expensive world of drug testing, where it can take hundreds of millions of dollars and many years to test a new drug, having a stem cell-derived micro tissue model represents a huge saving in time, money and resources that could be better spent elsewhere. That’s why many labs across the globe are working to create these models.

With the publication of their paper, Nimalan Thavandiran and his colleagues have shown how to significantly improve the formula for creating stem cell-derived cardiac tissue that behaves like more mature heart tissue. They have come closer than anyone to getting the mix right, factoring in the electrical and mechanical stimulation a heart experiences.

“The heart is consistently both being filled with blood and pumping blood, and so there is a constant mechanical force,” he says. “At the same time, the heart is constantly receiving electrical signals which help maintain synchronicity. All this is very difficult to recreate in a dish.”

They still have further to go, he says. “The ultimate goal is to be able to recreate a perfect micro environment for the heart so that we have an ideal model to screen drugs with.” But they are closing in on what could soon emerge as an important step in drug-testing.

“Until recently, researchers didn’t have the right micro fabrication techniques, the right materials, differentiation protocols, the right understanding of what co-factors are involved with these stem cell-derived heart cells. Now we have a relatively good understanding of all of these things.  It’s just the matter of putting it all together.”

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