ClinicalTrials.gov is a searchable database of clinical trials from around the world that are funded by public and private organizations. It’s a registry hosted by the USA-based National Institutes of Health (NIH) to provide doctors and their patients a resource to find appropriate studies for a variety of conditions. …
ClinicalTrials.gov is a searchable database of clinical trials from around the world that are funded by public and private organizations. It’s a registry hosted by the USA-based National Institutes of Health (NIH) to provide doctors and their patients a resource to find appropriate studies for a variety of conditions. A search on July 27th showed that there were over 1,400 stem cell clinical trials actively looking for patients.
It’s a great resource, and we link to it on our website, but patients should be aware that the studies listed are not vetted by the NIH.
Some private clinics are using the site as part of their marketing efforts to recruit new clients as shown in a recent study published by Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics.
“Many individuals use ClinicalTrials.gov to find legitimate, well-designed, and carefully conducted clinical trials. They are at risk of being misled by study listings that lend an air of legitimacy and credibility to clinics promoting unproven and unlicensed stem cell interventions” said Professor Turner in an interview with RegMedNet regarding the study.
Professor Turner found that private clinics used terms such as “pay to participate”, “patient-funded” or “patient-sponsored” when listing on ClinicalTrials.gov. Typically, patients are not charged to participate in a clinical trial but may be responsible for costs such as travel expenses.
The NIH recently added a disclaimer on the site that they do not endorse the studies listed and that patients should consult with “a trusted healthcare professional before volunteering for a study”. In addition, patients and their caregivers should be given information on how the study will be conducted, what the risks are and what the road to recovery might look like.
For more information regarding stem cell clinical trials, the International Society for Stem Cell Research provides a Web feature called Considering a stem cell treatment. For additional background, we recommend, What you need to know about stem cell therapies, a booklet prepared by the University of Alberta Faculty of Law, Albany Medical College and the Stem Cell Network.
Oscar Wilde once poetically waxed that “Memory… is the diary that we all carry about with us.” Two University of Toronto researchers recently published a review paper in journal Neuron that pointed to the fact that we only keep the memories that really matter to us. …
Oscar Wilde once poetically waxed that “Memory… is the diary that we all carry about with us.” Two University of Toronto researchers recently published a review paper in journal Neuron that pointed to the fact that we only keep the memories that really matter to us. Like a leather bound diary, our memory has finite amount of space and we erase the memories that we don’t have a particular attachment with to make room for new ones. This ultimately helps us with decision making as we only need to scan information that is valuable to us.
“It’s important that the brain forgets irrelevant details and instead focuses on the stuff that’s going to help make decisions in the real world,” says Dr. Blake Richards, co-author of the study, Assistant Professor at the University of Toronto’s Department of Biological Sciences, and a fellow in CIFAR’s Program in Learning in Machines & Brains, in an article posted on CIFAR’s website. “If you’re trying to navigate the world and your brain is constantly bringing up multiple conflicting memories, that makes it harder for you to make an informed decision,” adds Dr. Richards.
Beyond being assured that memory loss is part of a healthy brain and intelligent decision making, the research is interesting because it combined learnings from artificial intelligence (AI) with available stem cell research regarding the role of neural brain cells in memory.
“Canadian researchers are world-class leaders in both stem cell research and artificial intelligence – two fields that have significant potential to transform society. It’s truly exciting to continue this line of collaboration so that we can understand something as complex and important as the human brain” says Dr. Alan Bernstein, President and CEO of CIFAR and Chair of the Canadian Stem Cell Foundation.
Further collaborations between AI and the field of stem cell research could help researchers predict other types of cellular activity and ultimately accelerate the delivery of new treatment developments to the clinic.
The B.C. Tech Association recognized STEMCELL Technologies Inc. as the Company of the Year at its annual Technology Impact Awards (TIA) held this month.…
The B.C. Tech Association recognized STEMCELL Technologies Inc. as the Company of the Year at its annual Technology Impact Awards (TIA) held this month.
STEMCELL Technologies is one of Canada’s largest biotech firms and develops stem cell tools for researchers across the world. The company currently employs close to 1,000 people worldwide and saw its revenue grow 20% in 2016 according to an article posted by Business Vancouver.
Accepting the award, Dr. Allen Eaves, President and CEO, STEMCELL Technologies Inc. said “We want to be the company that is going to help support our health care system, [and] get it out of the terrible mess it’s in by providing new and wonderful tools that we will sell to the rest of the world,” as quoted by betakit.com.
We’ve written about Dr. Eaves previously on this site and his dedication to eradicating cancer.
Founded in 1994, the TIAs celebrate BC’s leaders and rising stars in the innovation and technology sectors. According to the Association, the technology sector in BC delivers nearly $25 billion in revenue and has been one of the strongest contributors to BC’s economic growth over the past decade employing over 90,000 people across 9,000 companies.
As Canada looks to grow our innovation economy, which is driven by entrepreneurship and increased productivity, the federal government has introduced a fast track work permit plan for highly skilled foreign workers to address our knowledge gap. …
As Canada looks to grow our innovation economy, which is driven by entrepreneurship and increased productivity, the federal government has introduced a fast track work permit plan for highly skilled foreign workers to address our knowledge gap. The program called Global Talent Stream launched June 12th and expedites the process for qualified and highly skilled talent to receive work permits in Canada within two weeks of applying.
“Being able to quickly attract the best and brightest minds to Canada — above and beyond the ones that already live here — is one way the federal government has listened to the needs of CEOs who are choosing to grow their companies in Canada”, notes Dr. Allen Eaves, President and CEO, STEMCELL Technologies Inc. in an opinion piece published in the Vancouver Sun .
Dr. Eaves knows first-hand what it takes to attract good people. Starting with 8 employees in 1993, STEMCELL Technologies has grown to over 1,000 current employees and has plans to expand to over 4,000 in the next 10 years. Over one-third of the staff hold a Doctorate or Masters and the majority of employees have a Bachelor of Science or Engineering degree.
This is good news for the stem cell sector as well as the general economy because of a multiplier effect. According to economist Enrico Moretti, each new high-tech job creates five additional jobs in the service economy. As quoted in the MIT Sloan Management Review, Moretti points out that “for each new high-tech job in a city, five additional jobs are ultimately created outside of the high-tech sector in that city,” He cites occupations such as lawyers, teachers, nurses, waiters, hairdressers and carpenters. This is three times higher than in other sectors such as manufacturing.
Applications for the Sartorius & Science Prize for Regenerative Medicine & Cell Therapy are being accepted now. The annual prize will be awarded to a researcher whose work has advanced the field of regenerative medicine and cell therapy.…
Applications for the Sartorius & Science Prize for Regenerative Medicine & Cell Therapy are being accepted now. The annual prize will be awarded to a researcher whose work has advanced the field of regenerative medicine and cell therapy.
The winner will receive $25,000 USD and their application essay will be published in Science magazine. The Grand Prize also includes a 5-year membership to The American Association for the Advancement of Science (AAAS) and an online subscription to Science.
Details about the prize and the application guide can be found here.
The prize is to raise the awareness for the field and is a collaborative effort between Sartorius, a leading pharmaceutical and laboratory equipment company, and AAAS.
Recognized for the contributions she has made throughout her career to advancing the field of stem cell research and regenerative medicine, University of Toronto’s Dr. …
Recognized for the contributions she has made throughout her career to advancing the field of stem cell research and regenerative medicine, University of Toronto’s Dr. Molly Shoichet has been awarded a 2017 Killam Prize along with $100,000 to advance her work.
“This award will accelerate our research and our efforts to improve the lives of people everywhere who are living with the effects of cancer, stroke, blindness and other currently irreversible conditions” commented Dr. Shoichet in an article published by the University of Toronto.
Dr. Shoichet’s research focuses on using biomaterials to enhance the effectiveness of stem cells in the treatment of conditions such as blindness and stroke. She developed a hydrogel platform to deliver stem cells to the brain and eyes to restore vision by 15 per cent. For that, and her other contributions to the field of stem cell research, Dr. Shoichet received the 2016 Till & McCulloch Award.
Beyond her research endeavors, Dr. Shoichet is a strong advocate for women in science and technology careers and was the L’Oreal-UNESCO Women in Science Laureate, North America for 2015. She also advocates for Canadian innovation and co-authored a piece published last year in iPolitics to promote Canada’s global leadership in the field of stem cell research and regenerative medicine.
More doctors treating aching joints with stem cells, even though treatment is costly, unproven and relief is only temporary
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.
Last fall we told the story of Dan Muscat, an Ontario jeweler whose combination chemo/stem cell transplant treatment helped him recover from scleroderma, an extremely painful, life-threatening autoimmune disease that hardens the skin and attacks internal organs.…
Last fall we told the story of Dan Muscat, an Ontario jeweler whose combination chemo/stem cell transplant treatment helped him recover from scleroderma, an extremely painful, life-threatening autoimmune disease that hardens the skin and attacks internal organs.
We believed then that his transplant, which took place at The Ottawa Hospital over the spring and summer of 2016, was the first time such a therapy had been tried in Canada. It even made news: CTV’s Avis Favaro profiled Dan early this year.
It turns out that other Canadian hospitals are trying — and have been using — the innovative therapy, which involves first extracting bone marrow stem cells from a patient to purify them, then wiping out their diseased immune system with chemotherapy, and finally returning the robust stem cells to the patient. The goal is to have these fortified stem cells rebuild a disease-free immune system.
Calgary’s Dr. Jan Storek has employed the chemo/stem cell treatment on “four or five” patients since 2011 and has contributed to the international Scleroderma: Cyclophosphamide Or Transplantation (SCOT) study, the results of which have yet to be published. He began working with the treatment in the 1990s at the Fred Hutchinson Cancer Center in Seattle.
“I was part of the development of transplants for autoimmune diseases,” says Dr. Storek. “Then the University of Calgary hired me to start a research program in bone marrow transplantation including transplantation for autoimmune diseases.”
He points to the work of Dr. Sharon LeClercq, a Calgary rheumatologist and expert in systemic sclerosis, without whose involvement there would have been no Canadian participation in a randomized study. “Patients participating in studies, particularly in the three randomized studies leading to this success should also be greatly acknowledged,” says Dr. Storek.
One of his transplant recipients is Miaya Killips, pictured above shortly after her 2016 transplant and as she is today. Miaya, who lives in Spruce Grove, Alberta, was diagnosed with scleroderma three years ago. She suffered lung damage, along with hardening of the skin. “I had limited mobility because my joints were tight and I was not able to swallow well — I would choke on food.”
These days, things are much better. “Scleroderma-wise, I’m feeling great. My mobility is much better and I don’t have the pain I had before. I am not choking when I eat and my lungs have stabilized, which is good because before the transplant my doctor had me on a standby list for a lung transplant.”
An electrician by trade, she wants to go back to school as part of a career change. And she and her husband plan to start a family soon, using embryos harvested through in vitro fertilization before she underwent chemotherapy.
We also heard from Shane Knihnitski, a 28-year-old heavy equipment mechanic who underwent a bone marrow stem cell transplant at Saskatoon’s Royal University Hospital in February to treat his scleroderma, which had caused large calcium deposits to form at his joints, resulting in considerable pain and restricted mobility.
“Things are turning around,” Shane says, “and the skin is starting to loosen up. I wasn’t able to see my elbow for two years — it was a big lump like a soft ball — but I can see the bone again.”
Dr. Keltie Anderson, Shane’s rheumatologist, says that while “it’s still very early” Shane has regained “a fairly significant amount of mobility in his hands already.
“When I first started seeing him, he could sort of cup his hands but couldn’t make a fist. Now he can bring the fingers all the way to the palm — almost make a full fist. To have such change already is very impressive.”
That the stem cell transplant procedure is having good results comes as great news to rheumatologists like Dr. Anderson who, until now, had few weapons with which to fight this painful, life-stealing disease. “Basically, you would do cyclophosphamide (a chemotherapy medication to suppress the immune system) and then cross your fingers.
“In Shane’s case he not only has extensive skin involvement, he also had extensive lung involvement. His outlook was quite bleak. And he’s a young guy and (he and his wife) just had their first child.”
Dr. Mohamed Elemary, who directs the hospital’s stem cell transplant program, says Shane was originally referred to Dr. Storek for inclusion in the Calgary study but it had already been completed. “So we started to review the data and see if it was something feasible for him here in Saskatoon. The stem cell transplant unit is run by the cancer centre and by the health region with the University Hospital. We can barely accommodate our patients with malignancies.”
After receiving permission to try the treatment with Shane, making sure he was a good candidate for the procedure, and consulting with Dr. Storek, Dr. Elemary went ahead with the transplant two months ago. “Our concerns vanished because he did tremendously well and was out of the hospital almost two weeks after his transplant. I just saw him a couple of weeks ago and I was amazed at the way that he is responding.”
The treatment does not come without risks. In Shane’s case, he was told there was a 20% chance the treatment could kill him. “But he came through it with flying colours,” says Dr. Anderson. “The last time I saw him he looked great. He didn’t look like someone who’d just gone through ablative chemotherapy with a stem cell transplant. And he was more upbeat than I’d seen him in a long time.”
Dr. Elemary is hoping to get approval to treat another scleroderma patient with stem cells and “with the success of Shane’s story” is optimistic that will happen.
In May, Calgary’s Dr. Storek, with co-authors Drs. LeClercq and Andrew Daly, will publish a report in the Canadian Medical Association Journal, reviewing the challenges of integrating the treatment in Canadian hospitals, given that stem cell transplantation programs are set up to treat patients with malignant cancers. Dr, Storek also
Dan Muscat, whose recovery continues, is delighted that more scleroderma patients are getting the treatment. “I’m trying to get the word out. This should be an option for people when they are diagnosed.”
Dr. Alan Bernstein, Chair of the Canadian Stem Cell Foundation, has been awarded the 2017 Henry G. Friesen International Prize in Health Research for his significant contributions to health and innovation. …
Dr. Alan Bernstein, Chair of the Canadian Stem Cell Foundation, has been awarded the 2017 Henry G. Friesen International Prize in Health Research for his significant contributions to health and innovation. The prize, established in 2005, recognizes “exceptional innovation by a visionary health leader”.
As the press release notes, there are many examples of Dr. Bernstein’s impact on health research and his ability to build strong collaborations.
- As the inaugural President of the Canadian Institutes of Health Research, he brought together biomedical, clinical and social scientists and set the standard for transdisciplinary research in Canada.
- Serving as the Executive Director of the Global HIV Vaccine Enterprise in New York, Dr. Bernstein built an international alliance of researchers and funders to accelerate the development of HIV vaccines.
- As the President & CEO of the Canadian Institute for Advanced Research, he promotes collaboration on a global scale by forging partnerships between international researchers to work on health, social and technological challenges.
Dr. Bernstein’s own stem cell and cancer research is rooted in strong partnerships as we wrote about here when he was inducted into the Canadian Medical Hall of Fame. A fellow of both the Royal Society of Canada and the Canadian Academy of Health Science, he is an Officer of the Order of Canada.
As the Chair of the Canadian Stem Cell Foundation, Dr. Bernstein was instrumental in the collaborative effort that brought together 150 scientists, doctors, leaders from health charities, industry experts and philanthropists to craft the Canadian Stem Cell Strategy with a unified vision to deliver 10 new stem cell therapies to the clinic within 10 years.
“Helen Keller is attributed with the quote ‘Alone we can do so little; together we can do so much’ and Alan’s career characterizes the sentiment,” noted James Price, President & CEO of the Canadian Stem Cell Foundation, “We congratulate Dr. Bernstein on this award and thank him for his exemplary leadership”.
Dr. Antoine Hakim, one of Canada’s truly inspirational medical leaders, is this year’s winner of the Gairdner Wightman Award.
Dr. Hakim is a long-time friend of the Canadian Stem Cell Foundation.…
Dr. Antoine Hakim, one of Canada’s truly inspirational medical leaders, is this year’s winner of the Gairdner Wightman Award.
Dr. Hakim is a long-time friend of the Canadian Stem Cell Foundation. He founded and led the Canadian Stroke Network that, in its early years, shared resources at The Ottawa Hospital with the Stem Cell Network — from which the Foundation sprang.
“We truly admire Tony Hakim for the amazing job he has done to advance stroke prevention and treatment,” said James Price, Foundation President and CEO. “He has served as a model for us all in working to improve Canadians’ lives.”
In today’s Ottawa Citizen, health writer Elizabeth Payne describes how, after working as a chemical engineer in Alberta, Dr. Hakim switched to medicine because he wanted to do something “more relevant.” On completing his residency in neurology at the Montreal Neurological Institute, he took up stroke as a research interest.
He became North America’s strongest advocate for increased use of the clot-busting drug TPA that, when administered in time, can greatly reduce the effects of a stroke.
“The revolution in stroke treatment,” the Citizen reports, “is seen in the many ‘miraculous’ recoveries he has witnessed in patients who come into the hospital severely handicapped and unable to speak and, within 48 hours, walk out of the hospital talking.”
At 74, Dr. Hakim continues his to enjoy his work, which gives him the opportunity to “keep pushing frontiers the best way I can.”
The other Gairdner 2017 laureates include:
- Japan’s Akira Endo for the first discovery and development of statins that have transformed the prevention and treatment of cardiovascular disease.
- California’s David Julius for determining the molecular basis of somatosensation — how we sense heat, cold and pain.
- Toronto’s Lewis E. Kay for the development of modern NMR spectroscopy.
- Italy’s Rino Rappuoli for pioneering the genomic approach, known as reverse vaccinology, used to develop a vaccine against meningococcus B.
- Texas’s Huda Y. Zoghbi for the discovery of the genetic basis of Rett syndrome and its implications for autism spectrum disorders.
- Brazil’s Cesar Victora, for outstanding contributions to maternal and child health and nutrition in low and middle income countries (John Dirks Canada Gairdner Global Health Award).
Winning a Gairdner, Canada’s top medical price, is often a precursor to even bigger things: 83 Gairdner laureates have gone on to win the Nobel Prize.