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21
Mar 2017
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BBC Assignment

BBC program raises concerns over potential dangers of unproven eye treatments

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Last week we wrote about three women whose vision was lost or damaged after they were injected with stem cells derived from their own fat tissue in a Florida clinic.…

Last week we wrote about three women whose vision was lost or damaged after they were injected with stem cells derived from their own fat tissue in a Florida clinic.

This week, a Calgary doctor who uses our website “to educate patients on avoiding the ‘pop up’ shops” offering unproven stem cell treatments, wrote to make us aware of a BBC podcast called  Assignment that recently featured an episode titled The Stem Cell Hard Sell.

The UK program focused on another Florida clinic that provides — for a $20,000 fee — eye implants derived from bone marrow stem cells drawn from a patient’s pelvis.  Central to the piece is the story of an American man named George Gibson who claims he lost sight in one eye after undergoing the procedure.

The treatment is part of a clinical study that’s listed with the U.S. National Institutes of Health called The Stem Cell Ophthalmology Treatment Study-(SCOTS). However it is unclear if the study is approved by the Food and Drug Administration (FDA).  The BBC program points out that researchers usually do not charge patients for the treatments in a clinical trial or study because the outcomes can’t be guaranteed.  As we have written in this space before, having patients pay for treatments tends to encourage them to “buy into” seeing favourable results that might not truly be there.

Dr. Paul Knoepfler, an American researcher whose lab conducts stem and cancer cell research at the University of California Davis School of Medicine in Sacramento, writes extensively about unproven stem cell treatments. His blog, The Niche, has dealt with SCOTS, drawing comments from one man who claims his vision was significantly improved and from others — including Mr. Gibson — who warn against the treatment.

A press release about the SCOTS trial, says investigators “hope that the treatment will be shown to improve vision in the vast majority of individuals who are enrolled” and mentions that “previous anecdotal experience with eye disease treated with stem cells has been positive.” However a disclaimer states that “no guarantees of specific improvements or visual results are being made” and that “any medical procedure carries risks as well as potential benefits.” The study, to include 300 patients, has published two case studies of patients whose vision improved.

Our Towards Treatment section explains that we currently know of no Health Canada of FDA approved stem cell treatments for eye disease.  Anyone considering such a treatment or participating in a study or trial should consult with their doctors and medical professionals.  As well, the International Society for Stem Cell Research has great information for anyone considering any type of stem cell treatment. You can find it here.

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16
Mar 2017
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Eye Disease

Unproven stem cell treatment leaves three women blind

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Three women who believed they were participating in a clinical trial either lost all or most of their vision after being injected with stem cells derived from their own fat in a Florida clinic. …

Three women who believed they were participating in a clinical trial either lost all or most of their vision after being injected with stem cells derived from their own fat in a Florida clinic.  The case points to the dangers of unproven treatments offered by private clinics.

Within days of treatment the women, who all suffered from macular degeneration, began to experience severe side effects including bleeding in the eye, detached retinas and vision loss as reported in a study released week in The New England Journal of Medicine.   Expert ophthalmologists tried to reverse the damage but were unable.

“There’s a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous”  said Dr. Thomas Alibini, a lead author of the study, in a press release.

This isn’t the first time there have been adverse reactions to unproven treatments offered at clinics, many using stem cells drawn from the patient’s own fat, and we’ve written about it several times on this blog warning patients to be cautious of claims that appear too good to be true.

So how can patients protect themselves?  The California Institute of Regenerative Medicine offers this advice:

  • There is almost no evidence that the fat/blood stem cell combination the clinic used could help repair the photoreceptor cells in the eye that are attacked in macular degeneration.
  • The clinic charged the women $5,000 for the procedure. Usually in Food and Drug Administration (FDA)-approved trials the clinical trial sponsor will cover the cost of the therapy being tested.
  • Both eyes were injected at the same time.  Most clinical trials would only treat one eye at a time and allow up to 30 days between patients to ensure the approach was safe.
  • Even though the treatment was listed on the clinicaltrials.gov website, there is no evidence that this was part of a clinical trial, and certainly not one approved by the FDA.

Most importantly, patients should check with their doctor before considering any medical treatment or participating in any clinical trial.  You can also find great information for patients considering stem cell treatments here that has been produced by the International Society for Stem Cell Research (ISSCR).

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09
Mar 2017
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Dr. Janet Rossant

Dr. Janet Rossant

New report echoes call to build on Canada’s stem cell strength

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Stem cells have the potential to transform Canadian health care by improving patient outcomes and making the system more efficient, according to a new report by the Council of Canadian Academies (CCA).…

Stem cells have the potential to transform Canadian health care by improving patient outcomes and making the system more efficient, according to a new report by the Council of Canadian Academies (CCA).

Titled Building on Canada’s Strengths in Regenerative Medicine, the report was commissioned by the federal government’s Ministries of Innovation, Science and Economic Development (ISED) and Health Canada

“We especially appreciate Science Minister Kirsty Duncan’s efforts at highlighting Canada’s academic research strengths in stem cells,” said James Price, President and CEO of the Canadian Stem Cell Foundation. “This is another good example — this time focusing on academic strengths — of how Canada’s depth in stem cells and regenerative medicine is now being widely recognized.

The CCA document follows last month’s report by the Finance Minister Bill Morneau’s Advisory Council on Economic Growth that singled out the stem cell sector and suggested that building on Canada’s “world-class regenerative medicine and stem cell therapy development“ could unlock innovation and drive economic growth.

The CCA report, the release of which coincides with the beginning of the two-day PanCanadian Strategic Forum on Cell and Gene Therapy in Montreal, hosted by CellCAN — Regenerative Medicine and Cell Therapy Network and BioCanRx.  It will feature a panel discussion, moderated by Mr. Price and featuring a talk by Dr. Janet Rossant, chair of the steering committee that produced the CCA report, looking at ways to move the field forward.

Among the report’s key findings:

  • There is a need for a long-term funding strategy to encourage research and development across the country.
  • There is an opportunity to accelerate translation of research discoveries into clinical applications.
  • There needs to be greater co-ordination between the federal regulators who decide about the safety and efficacy of stem cell/regenerative medicine therapies and the provincial reimbursers who decide what therapies will be covered by health care plans.

 

 

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28
Feb 2017
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Imperial College London Capture

UK study further substantiates stem cell treatment for MS

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Last summer we blogged about a team at The Ottawa Hospital that had proved a stem cell/chemo combo treatment could halt the progression of multiple sclerosis (MS) and — in some cases — help patients recover from the autoimmune disease.…

Last summer we blogged about a team at The Ottawa Hospital that had proved a stem cell/chemo combo treatment could halt the progression of multiple sclerosis (MS) and — in some cases — help patients recover from the autoimmune disease.

Now comes news from the United Kingdom that further substantiates the work of Drs. Harry Atkins and Mark Freedman in showing that using bone marrow stem cell transplants to rebuild an MS patient’s immune system can prevent the disease from worsening and dramatically improve mobility and freedom from pain for some.

The Atkins-Freedman study, published in the prestigious Lancet journal, focused on two dozen patients treated over a decade. The UK study, published last week in JAMA Neurology, reviewed 281 patients tracked over five years. Led by Dr. Paolo Muraro of Imperial College London, the study found the treatment prevented symptoms of severe disease from worsening for five years for almost half of the patients treated.  Drs. Atkins and Freedman co-authored the UK study and  results from their work were included in the review.

Among patients with relapsing MS, nearly three in four saw no worsening of their symptoms five years after treatment, while younger patients with less severe forms of the disease were more likely respond to the therapy. Most of the patients, though, had progressive MS, which is more severe.  Among them, one in three experienced no worsening of symptoms, according to a report by Imperial College.

MS occurs when a person’s immune system misfires and begins attacking nerves in the brain and spinal cord. Currently, there is no treatment for sever, progressive MS.

In essence, the new approach, which is called autologous hematopoietic stem cell transplantation, involves extracting the patient’s own bone marrow stem cells and fortifying them, then destroying their immune system through chemotherapy. The stem cells are then transplanted back into the patient to rebuild the immune system — ideally without the disease.

The stem cell/chemo treatment is not for everyone who has MS — young people with more robust stem cells tend to respond better than older patients — and it comes with risks. Eight patients died following the treatment.

Dr. Muraro said the risks must be weighed against the benefits: “We previously knew this treatment reboots or resets the immune system – and that it carried risks – but we didn’t know how long the benefits lasted. In this study, which is the largest long-term follow-up study of this procedure, we’ve shown we can ‘freeze’ a patient’s disease – and stop it from becoming worse, for up to five years.”

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15
Feb 2017
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Strategic Forum on cell therapies asks, ‘Where do we go from here?’

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What will it take to move regenerative medicine forward so that it can deliver more cures and treatments for age-old diseases?…

What will it take to move regenerative medicine forward so that it can deliver more cures and treatments for age-old diseases?

That’s the subject of the First PanCanadian Strategic Forum on Cell and Gene Therapy to be held March 9 and 10 at the Westin Montreal.

“The cell and gene therapy ecosystem in Canada is coming to a level of maturity where we’re going to be ready to reap the fruit from it,” says Dr. Anne-Marie Alarco, former Chief Scientific Officer of CellCAN — Regenerative Medicine and Cell Therapy Network.  “But it’s not going to happen passively. We have to put action in place.”

CellCAN is organizing the Forum in partnership with the Centre for Commercialization of Cancer Immunotherapy (C3i) and BioCanRx.

There is a sense of urgency to begin harvesting the “low hanging fruit,” says Dr. Alarco.  Otherwise, she says, Canada could miss out.

Unlike the annual Till & McCulloch Meetings, which focus on the most recent scientific advances in cell therapies and regenerative medicine, the Strategic Forum will concentrate on what’s needed to move therapies into the clinic. Organizers expect to draw a range of academics, scientists, health agency representatives, government regulators, venture capitalists and business leaders from pharma and biotech.

“The idea is to bring together all the major stakeholders,” says Dr. Alarco, “to determine where we are in terms of cell therapies and gene therapies. We have all the elements for what we hope will be an interactive conversation.  Hopefully, we will come up with a number action items.”

Lectures and workshops will consider ways to overcome barriers to implementing cell and gene therapies in Canada; build on effective commercialization for the benefit of all Canadians; and identify reimbursement possibilities for developing novel therapies..

Keynote speaker Dr Janet Rossant, President & Scientific Director of the Gairdner Foundation and Chair of the steering committee of the Council of Canadian Academies Workshop on Regenerative Medicine. Their soon-to-be-released report was commissioned by the federal government.

As well, speakers from the United Kingdom, Japan and California will discuss steps taken in their jurisdictions to move the science from the researchers’ laboratories to the patients’ bedsides.

“It is the medicine of the future,” says Dr. Alarco. “We hope to have action items in for this to become a reality for Canadians.”

 

 

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14
Feb 2017
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Dr. Lambert Busque

Dr. Lambert Busque

Is Canada ready for The Next Big Thing in cancer treatment?

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Think of cancer immunotherapy as an inside job:  While chemotherapy and radiation destroy cancer cells from the outside, cancer immunotherapy deploys the patient’s own immune system to attack the disease from within.…

Think of cancer immunotherapy as an inside job:  While chemotherapy and radiation destroy cancer cells from the outside, cancer immunotherapy deploys the patient’s own immune system to attack the disease from within.

Cancer immunotherapy’s arsenal of immunotherapies ranges from monoclonal antibodies that can target malignant cells, inhibitors that help the immune system recognize and attack cancer cells, vaccines that trigger an anti-cancer response, and re-engineered and expanded T-cells designed to kill specific cancer cells.

For patients, the life-enhancing prospects of not having to endure the toxic side-effects of chemo and radiation are almost as appealing as the life-saving cures that this revolutionary field of oncological research is poised to deliver.

”The evidence suggests we are at the beginning of a whole new era for cancer treatments,” Prof. Peter Johnson, Director of Medical Oncology at Cancer Research UK, told the Daily Mail in 2015.  Things have only accelerated since then for The Next Big Thing in cancer care.

The cancer immunotherapy revolution is moving fast and turning the oncology world upside down, according to Dr. Lambert Busque, Chief Medical Officer of the Centre for Commercialization of Cancer immunotherapy (C3i).  Established last year by Canada’s Networks of Centres of Excellence, C3i predicts that immunotherapy could be used in the majority of advanced cancer cases in less than a decade.

Which raises the question: is Canada ready for this revolution in cancer care?

“There is a lot of knowledge and competence in Canada,” says Dr. Busque, whose C3i organization operates out of the Hôpital Maisonneuve-Rosemont’s Integrated University Center of East Montreal.  But, he says, Canada needs greater capacity to translate immunotherapies into patient care and to help Canadian companies compete in a rapidly growing global market.

To address those concerns, C3i is partnering with CellCAN Regenerative Medicine and Cell Therapy Network and BioCanRx to host next month’s PanCanadian Strategic Forum on Cell and Gene Therapy in Montreal.  Dr. Busque will moderate a panel discussion on what it will take for Canada to become a world leader in commercializing cancer immunotherapy, drawing on the C3i model.

“We designed C3i to be very close to the clinic,” says Dr. Busque.  “Because treatment and health care is part of the public sector while development is done in the private sector, the key is to make the link between them, to have a structure to help Canadian inventions mature rapidly and have better access to markets.  If we have no instrument to do that, the development will go outside the country.”

Canada, in fact, could become a hub for cancer immunotherapy development if 3Ci can succeed strengthening collaborations with major pharmaceutical firms in driving clinical trial development.  Dr. Busque cites C3i’s access to a “state of the art” certified Good Manufacturing Practice (GMP) cell manufacturing unit as critical for conducting trials and developing cell-based and biological therapeutics.

C3i is also making the development of biomarkers a priority.  Because not all cancer patients respond in the same way with the same immunotherapy, researchers worldwide have focused their attention on developing biomarkers that can predict therapy outcomes and help doctors tailor treatments to a particular patient or type of patient.

“Biomarkers will be crucial in the development of therapies,” says Dr. Busque.  “So we are developing a biomarker unit with next generation computer sequencing to do cutting edge analysis of cellular biomarkers.”

Having already built a network of oncology centres across Quebec, C3i hopes to create linkages across Canada to expand access to patients for larger scale clinical trials.

“We’re not alone.  We’re going to be one piece of a large puzzle in Canada.  There are so many great contributions being made across Canada.  We hope to be a catalyst in respect to Canadian collaborations because Canada can be extremely successful.”

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16
Jan 2017
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Canadian Press photo

Canadian Press photo

Globe series highlights Till & McCulloch’s remarkable stem cell discovery

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Sometimes popular recognition takes time.  After more than 50 years, Drs. James Till and Ernest McCulloch are finally getting their moment in the spotlight of public appreciation.…

Sometimes popular recognition takes time.  After more than 50 years, Drs. James Till and Ernest McCulloch are finally getting their moment in the spotlight of public appreciation.

The Globe & Mail’s ongoing Great Canadian Inventions series, which highlights people, products and discoveries that have changed the world, today features the two great men who proved the existence of stem cells back in the early 1960s. The series runs throughout 2017 to mark the 150th anniversary of Confederation.

The Globe’s public health reporter André Picard reports that the discovery “is considered among the most seminal medical findings of the past century, on par with the discovery of the double-helical structure of DNA by James Watson and Francis Crick.”

Stem cells have revolutionized cancer treatment and set the stage for the emergence of new therapies for a wide range of currently incurable diseases. New treatments are already succeeding in overcoming autoimmune diseases like MS.

Stem cells are also good for the economy.  The article cites STEMCELL Technologies, the Vancouver-based biotech company founded by former Till & McCulloch postgraduate student Dr. Allen Eaves, as a key player in a burgeoning field that is expected to produce a $49-billion global market within four years.

James Price, President & CEO of the Canadian Stem Cell Foundation, notes in the Globe piece that the Till & McCulloch discovery initially didn’t get the attention it deserved. “But they set the stage for all the current stem cell research and helped make Canada a magnet for talent and investment in biotech.”

The article comes after last fall’s unveiling of the Till & McCulloch statue outside doors of BC’s Telus Science World in Vancouver. A duplicate statue is to be installed in downtown Toronto this spring.  It marks a considerable turnaround in recognition. In 2004, CBC Television ran a series called The Greatest Canadian, compiling a list of the 100 greatest Canadians ever. They followed it with a 2007 series on 50 of the Greatest Canadian Inventions.  While Don Cherry was featured in the former and the Wonder Bra in the latter, Till & McCulloch and stem cells were left out of both.

The Globe series, however,  got right to it in recognizing Till & McCulloch: they are the second Canadians to be featured this year after a Jan. 9th article celebrated how Jacques Plante changed the game of hockey by popularizing the goalie mask.

Dr. Till, a professor emeritus at the University of Toronto, remains busy as a leading advocate for opening access to scientific journals. Dr. McCulloch died in 2011. The remarkable story of Till & McCulloch’s stem cell discovery and their amazing legacy is told in Dreams & Due Diligence, published by University of Toronto Press and available through their website or via Amazon books.

 

 

 

 

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03
Jan 2017
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CTV tells story of Dan Muscat’s ‘180-degree’ turnaround

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In this blog and in our Fall/Winter newsletter we told the story of Dan Muscat, the St. Thomas, Ontario jeweler who has seen remarkable reductions in the symptoms of his scleroderma — a painful and deadly disease that turns the skin of its victims into cement-like hardness and then petrifies their internal organs.…

In this blog and in our Fall/Winter newsletter we told the story of Dan Muscat, the St. Thomas, Ontario jeweler who has seen remarkable reductions in the symptoms of his scleroderma — a painful and deadly disease that turns the skin of its victims into cement-like hardness and then petrifies their internal organs.

Over the summer, Dan underwent an experimental stem cell therapy at The Ottawa Hospital under the care of Dr. Harry Atkins, who has done outstanding work in treating patients with other autoimmune diseases such as multiple sclerosis, Stiff Person’s Syndrome and Crohn’s disease using a combination chemotherapy/stem cell approach.

Avis Favaro reported on Dan’s “180-degree” turnaround on CTV National News last night, telling Dan’s powerful story. You can watch it here.

After the initial report, the CTV website provides a four-minute interview with Dan that goes into greater detail, along with interviews with Dr. Atkins and James Price, President and CEO of the Canadian Stem Cell Foundation, who says “Dan’s story is an exciting one for the field.”

As Ms Favaro says at the end of her report, Dan continues to get improve and is now able to walk three kilometres on a treadmill. While the extreme treatment isn’t for all scleroderma patients — it comes with potentially fatal risks — it offers new hope where none existed before.

In the wake of the CTV story on Dan,  The Ottawa Hospital has produced an online resource for people seeking more information about chemo/stem cell treatments for scleroderma and other autoimmune diseases like MS and Stiff Person’s Syndrome. You can find it here.

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15
Dec 2016
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New test helps tailor treatments for high-risk leukemia patients

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Researchers at Princess Margaret Cancer Centre in Toronto have developed a test to predict responses to standard treatments in patients with acute myeloid leukemia (AML) — one of the most deadly and common types of adult leukemia.…

Researchers at Princess Margaret Cancer Centre in Toronto have developed a test to predict responses to standard treatments in patients with acute myeloid leukemia (AML) — one of the most deadly and common types of adult leukemia.

The test is designed to be administered in tandem with diagnosis so that once the marker is identified, an individual treatment plan can be prepared.

“Clinicians will now have a tool that they can use upfront to tailor treatment to risk in AML,” says Dr. Jean Wang, Affiliate Scientist at the Princess Margaret and Co-Principle Investigator of the study in a press release from the University Health Network.

The marker identifies a 17-gene signature derived from leukemia stem cells that are resistant to standard chemotherapy and cause relapse for patients. Based on a rigorous statistical approach, a “stemness score” measures a patient’s probability for chemo resistant cells. With this knowledge, clinicians will be able to enroll high-risk patients in clinical trials to test alternative therapies to chemotherapy alone.

The test not only provides a fast turnaround time for patients as they decide the best course of care, it also represents the first time a stem cell-based biomarker has been developed in this way for human cancer.

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12
Dec 2016
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A major boost for Canada’s stem cell sector: Bayer/Versant Ventures invest $225 million

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The announcement by Bayer AG and Versant Ventures that they will invest $225 million U.S. to create a Toronto-based cell-therapy company shows the massive opportunities to be realized in the next wave of stem cell R&D and illustrates how visibility and support for the sector is soaring.…

The announcement by Bayer AG and Versant Ventures that they will invest $225 million U.S. to create a Toronto-based cell-therapy company shows the massive opportunities to be realized in the next wave of stem cell R&D and illustrates how visibility and support for the sector is soaring.

“We think we’re on the cutting edge of the next generation of stem-cell therapies,” said Brad Bolzon, Managing Director of Versant Ventures in a report by the Globe and Mail.

According to Bayer’s press release, the new company, called BlueRock Therapeutics, will advance breakthrough treatments based on latest stem cell technology with an initial focus on finding treatments for cardiovascular diseases and neurodegenerative disorders like Parkinson’s disease, two areas where Canadian research is particularly strong.  The investment, one of the largest-ever first-round financings for a biotech company, gives BlueRock Therapeutics at least four years to get a number of programs into the clinic.

It comes in the wake of several developments including the Stem Cell Network’s announcement of $9 million in funding for projects to turn research into new treatments and the Canada First Research Excellence Fund’s $114-million grant to the University of Toronto’s Medicine by Design program.  As well, the Centre for Commercialization of Regenerative Medicine announced earlier this year that it will receive $20 million in federal funds, matched by GE Healthcare, to develop cell manufacturing capacity in Canada.

“All of these announcements align with the Canadian Stem Cell Strategy’s goals of mobilizing private capital and attracting investment,” said James Price, President and CEO of the Canadian Stem Cell Foundation.  “They are strong indications that Canada is well positioned to lead in the next wave of stem cell advances.  That’s why we’re seeking a commitment from the Liberal Government to make stem cell research and development a national priority.”

The Canadian Stem Cell Strategy is designed to deliver 10 new therapies to the clinic within 10 years, create 12,000 jobs and position Canada as a global leader in the field.  It calls on the Government to provide one-third of the total investment, about $50 million annually over 10 years for a total of $500 million, to be doubled by $1 billion in private and philanthropic investments.

An indication of the economic power of stem cell R&D is exemplified by BC’s STEMCELL Technologies Inc., which, with 900 workers and $150 million in annual revenues, has become Canada’s largest biotech by selling high-quality “Made in Canada” stem cell products worldwide.

“We have a huge opportunity in front of us, an opportunity we don’t want to miss,” said Mr.  Price.  “Visibility and support for the sector has never been stronger.  We just need to take the next big step forward with the Strategy.”

 

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