unproven treatments

21
Mar 2017
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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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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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26
Jun 2014
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stemcelltourism stem cellshorts

Tricky science made simple, Part III

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Back in January, we blogged about the StemCellShorts videos, a series of about-a-minute-long informative videos produced by Ben Paylor, a PhD candidate at the University of British Columbia, and Dr.

Back in January, we blogged about the StemCellShorts videos, a series of about-a-minute-long informative videos produced by Ben Paylor, a PhD candidate at the University of British Columbia, and Dr. Mike Long, a post-doctoral fellow at the University of Toronto.

A brand new video in the excellent series is now available. Narrated by Prof. Timothy Caulfield, a member of our Foundation’s Science Leadership Council, it answers the question “What is stem cell tourism?”

Stem cell tourism is one of the biggest challenges for stem cell community. While great advances have been made in bone marrow stem cell transplants and stem-cell driven skin grafts, most stem cell treatments are still in the research phase. However, the number of clinics offering unproven and unsafe therapies worldwide is growing. (Click here to read our blog entries about stem cell tourism.)

All the videos — including “What is a stem cell?” narrated by Dr. Jim Till, “What are embryonic stem cells?” voiced by Dr. Janet Rossant, and “What are induced pluripotent stem cells?” narrated by Dr. Mick Bathia —  are now available on the Foundation’s You Tube channel. Click here to view them.

Another instalment, covering the topic “What is a cancer stem cell?” and narrated by Dr. John Dick, will be launched later this year. This second set of videos is co-sponsored by the Canadian Stem Cell Foundation and the Stem Cell Network.

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13
Mar 2014
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unproven stem cell treatments booklet

Unproven stem cell therapies: all you need to know

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Recently we wrote about a workshop on unproven stem cells treatments that featured Prof. Timothy Caulfield, a member of our Foundation’s Science Leadership Council.…

Recently we wrote about a workshop on unproven stem cells treatments that featured Prof. Timothy Caulfield, a member of our Foundation’s Science Leadership Council. Unproven stem cells treatments are scientifically untested, lack regulatory or ethics approval and may lead to serious health consequences.

In order to increase public awareness, the University of Alberta’s Prof. Caulfield and Dr. Zubin Master of Albany Medical College, have developed a booklet called “What you need to know about stem cell therapies.”

The booklet, sponsored by Stem Cell Network, can be found here.

“Most stem cell therapies are still considered research and are a long way from the clinic,” write the authors.

The process of translation from scientific knowledge to the approval of a treatment, or clinical translation, takes several steps. It starts with preclinical research, with scientists using stem cells on animals to show that the treatment is safe and effective.

After a review from independent scientists, or peer review, the research undergoes ethics approval to be tested on humans. With approval, clinical research involving humans, begins, starting at Phase 1 to determine whether the treatment is safe, to Phase 4, which monitors the effectiveness of a treatment and its side effects after it is on the market.

Unproven stem cells therapies have not been properly tested and proven to be safe and effective.

According to Prof. Caulfield and Dr. Master, clinics offering unproven treatments share similar characteristics: They don’t provide scientific evidence of the effectiveness of a treatment and they emphasize its benefits without completely explaining its risks. Instead of scientific publications, they use patient testimonials to show the effectiveness of a therapy. Finally, the costs associated with unproven treatments are often high, while legitimate clinical trials are free.

Patients undergoing unproven stem cell therapies may develop serious health problems, as their condition may worsen, or they may require additional treatments. Undergoing an unproven treatment can also disqualify a patient for enrolment in legitimate stem cell trials.

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