Stem Cell Tourism

27
Jun 2016
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Putting a face on the dangers of stem cell tourism

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Jim Gass, a 66-year-old lawyer who now lives in San Diego, has inadvertently become the human face of the dangers of stem cell tourism.…

Jim Gass, a 66-year-old lawyer who now lives in San Diego, has inadvertently become the human face of the dangers of stem cell tourism.

A feature in the New York Times headlined “A Cautionary Tale of Stem Cell Therapy Abroad” tells of how Mr. Gass spent $300,000 by travelling to clinics in Mexico, China, and Argentina in search of a miracle stem cell cure after he had a stroke. Recently, his American doctors found a huge mass of someone else’s cells growing aggressively in his lower spine.

As the article explains, Mr Gass travelled from clinic to clinic believing that the worst that could happen was there would be no improvement in his post-stroke condition, which left his left arm useless and his left leg weak. Except for being able to use his right arm, he is now paralyzed from the neck down.

In Mexico he received an injection of fetal cells shipped from Russia that, for a time, seemed to improve his ability to walk: “Then something disturbing happened,” Mr. Gass told the Times. “I felt pain when I would lie down, like I was lying on a tumor. “I started to lose my ability to walk and I fell down a lot.”

That’s when Boston doctors found the mass containing someone else’s primitive cells. They treated it with radiation, which seemed to slow its growth, but the mass is growing again.

As discussed on the Treatments Abroad page on our website, scientific discoveries and innovations surrounding the potential of stem cell science have led to great enthusiasm about potential benefits to patients.  But the dark side of that enthusiasm is the hype, exaggerated publicity and inaccurate claims in the interest of financial gain.

Many unregulated clinics around the world offer treatments that are simply not based on sound scientific evidence. If you or someone you know is considering such a therapy, you’d be wise to consult a booklet produced by the University of Alberta Faculty of Law, Albany Medical College and the Stem Cell Network entitled What you need to know about stem cell therapies.  A PDF version is available here.

An excellent web resource is the International Society of Stem Cell Research Web page: A Closer look at Stem Cells. It includes a Patient Handbook downloadable in several languages.

Both sources advise potential patients to be wary of clinics that offer patient testimonials in place of evidence gathered through rigorous clinical trials.  Or, as Mr. Gass now says: “Don’t trust anecdotes.”

 

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24
Feb 2016
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FDA to crack down on clinics peddling unproven stem cell treatments

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Federal regulators in the United States are about to crack down on hundreds of clinics peddling pricey stem cell therapies to treat a laundry list of diseases and conditions without scientific evidence to back them up.…

Federal regulators in the United States are about to crack down on hundreds of clinics peddling pricey stem cell therapies to treat a laundry list of diseases and conditions without scientific evidence to back them up.

According to a report by STAT, an online health and medicine news service, some 200 stem cell clinics have cropped up in recent years, selling injections, facelifts, and treatments that have not undergone clinical trials.

Many of the clinics use a procedure called stromal vascular fraction (SVF) in which cells are extracted from a patient by liposuction, run through a centrifuge to collect the adipose (fat) stem cells and returned to the patient intravenously or injected at the site of the condition. Clinics promote the SVF procedure to treat a variety of conditions such as arthritis, Parkinson’s disease, pulmonary fibrosis, chronic obstructive pulmonary disease, multiple sclerosis, cerebral palsy, and amyotrophic lateral sclerosis. Treatments can cost anywhere from $5,000 to $25,000.

The American Food and Drug Administration (FDA) recently issued draft guidelines on the use of human cells, tissues, or cellular or tissue-based products and will hold a public hearing on April 13 at Silver Spring, Maryland to help finalize its stand on such treatments.

As STAT reported,  the FDA already sent a warning letter  to a network of stem cell clinics in California, New York, and Florida advising the owner that he needed FDA approval to sell and use stem cells, which the agency classified as biological drugs.

FDA approval requires evidence that stem cell treatments are safe and effective, which, as the article points out, “takes drug companies many years of clinical trials to obtain, at a cost of millions of dollars.”

Canadian bioethicist Dr. Leigh Turner of the University of Minnesota has long criticized the FDA for failing to crack down on the clinics as the mushroomed across the U.S. “If it’s not safe and it’s not going to help patients,” Dr. Turner told STAT. “It’s just predatory behavior.”

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04
Nov 2015
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Montreal event aims to separate stem cell myths from realities

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When it comes to stem cells and regenerative medicine, how can you tell the difference between fiction and reality?

Remarkable advances in stem cell research have led to sensational claims — especially from private clinics offering miraculous cures for a myriad of diseases. …

When it comes to stem cells and regenerative medicine, how can you tell the difference between fiction and reality?

Remarkable advances in stem cell research have led to sensational claims — especially from private clinics offering miraculous cures for a myriad of diseases.  But what’s the real story?

Our colleagues at CellCAN Regenerative Medicine and Cell Therapy Network hope to clear the air this week with an Information Day on Cell Therapy. The Thursday, Nov. 5th session at Montreal’s La Grande Place, complexe Desjardins – 150, Ste-Catherine West, runs from 10 a.m. to 4 p.m. with a panel discussion at noon.

CellCAN has developed an app for event participants to view to our Foundation’s Toward Treatments summaries of the state of stem cell research into 19 diseases.  You can find them here.

Organizers say the goal of the day is to distinguish “myths from the realities, and embrace the true potential of stem cells” so that “more Canadians benefit from this revolutionary medicine.”

 

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01
Feb 2015
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Dr. Mick Bhatia

Dr. Mick Bhatia puts Howe case into perspective on Day 6

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Dr. Mick Bhatia, Director of McMaster University’s Stem Cell and Cancer Research Institute, was the featured guest on CBC Radio’s Day 6 program on Saturday morning as it delved into the controversial subject of stem cell tourism.…

Dr. Mick Bhatia, Director of McMaster University’s Stem Cell and Cancer Research Institute, was the featured guest on CBC Radio’s Day 6 program on Saturday morning as it delved into the controversial subject of stem cell tourism.

Host Brent Bambury interviewed Dr. Bhatia, a member of our Foundation’s Science Leadership Council, to get his expert perspective on stroke survivor Gordie Howe’s so-called “miraculous” recovery after he travelled to Tijuana for an experimental treatment.

Along with the high costs people often pay for unproven therapies that often do not produce results, Dr. Bhatia warned of the physical dangers of untested treatments. He pointed out that unlike a drug that can be discontinued in the event of an adverse effect, “if a cell goes rogue in the body” there is no way of controlling it. “Cells can go anywhere and can grow uncontrollably,” producing tumours.

Foundation CEO & President James Price says Howe’s case underscores the need to implement the Canadian Stem Cell Strategy & Action Plan. “Canada has a world-class stem cell sector and we are poised to bring new treatments to the clinic. It’s about bringing more clinical trials to Canada so that Canadians have early access to therapies that are proven to be safe and effective.”

 

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30
Jan 2015
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Doubts about Howe’s treatment underscore need for Strategy

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The experimental stem cell treatment Gordie Howe underwent in Tijuana in December has raised further scientific concerns.

According to a report by Canadian Press health writer Sheryl Ubelacker that was carried online by the Globe and Mail, regenerative medicine experts question whether stem cells are actually responsible for what Howe’s son has called a “miraculous” recovery.…

The experimental stem cell treatment Gordie Howe underwent in Tijuana in December has raised further scientific concerns.

According to a report by Canadian Press health writer Sheryl Ubelacker that was carried online by the Globe and Mail, regenerative medicine experts question whether stem cells are actually responsible for what Howe’s son has called a “miraculous” recovery.

According to Dr. Mick Bhatia, Director of the Stem Cell and Cancer Research Institute at McMaster University, Howe’s apparent recovery has many unknown factors. “Is this a transient effect, or is it really a perceived or somewhat of a placebo effect and is there something really happening? Scientifically and biologically that is important,” he told CP.

In addition, Dr. Bhatia is concerned that immunosuppression drugs or any other drugs Howe might have taken before the treatment could be showing some of the improvement effects. “We really don’t know.”

Dr. Michael Rudnicki, CEO and Scientific Director of the Stem Cell Network and a member of the Foundation’s Board of Directors, told CP  that while he couldn’t speak specifically about Howe’s treatment in Mexico as it’s not clear how much the hockey legend has improved or whether the stem cell treatment he received was responsible, some patients have suffered adverse effects from therapies received at clinics abroad. “There’s real potential for doing harm,” said Dr. Rudnicki. “And a person claiming to get better doesn’t prove anything,” he added.

Although there is currently no stem cell treatment for stroke approved by Health Canada, the Canadian Stem Cell Strategy & Action Plan will lead the way to delivering five to 10 novel treatments for chronic diseases within 10 years.

If Canada makes stem cell research and development a national priority, the Strategy will ultimately ensure the access to stem cell treatments that are proven to be safe and effective.

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20
Jan 2015
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Strategy will streamline the process for clinical trials in Canada

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The controversy over the experimental stem cell treatment in India grabbed national headlines last week.

Alberta businessman Lee Chuckry told CBC News in Manitoba that he spent $34,000 for a stem cell therapy in India only to find his MS got worse and that “I think it’s just a big fraudulent scam.” However, another MS patient who took part in the experimental trial claims the treatment helped her.…

The controversy over the experimental stem cell treatment in India grabbed national headlines last week.

Alberta businessman Lee Chuckry told CBC News in Manitoba that he spent $34,000 for a stem cell therapy in India only to find his MS got worse and that “I think it’s just a big fraudulent scam.” However, another MS patient who took part in the experimental trial claims the treatment helped her.

The controversy points to the need for Canada to make stem cell research and development a national priority. Always a clear leader in stem cell research, Canada needs a coordinated strategy to bring health benefits for Canadians. The goal of the Stem Cell Strategy & Action Plan is for Canada to lead the way in delivering five to 10 safe and effective treatments for chronic diseases within 10 years.

CBC News visited Foundation’s offices in Ottawa to ask President and CEO James Price about the goals of the Strategy. He told the CBC that the Strategy will streamline the process for clinical trials in Canada “so that Canadians that are suffering have access to treatments that are safe and proven to be effective.”

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15
Jan 2015
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Controversies over stem cell tourism underscore need for Strategy

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Two days after we blogged about the scientific concerns regarding Gordie Howe’s experimental stem cell treatment in Tijuana, another example of Canadians seeking unproven therapies abroad has hit the media.…

Two days after we blogged about the scientific concerns regarding Gordie Howe’s experimental stem cell treatment in Tijuana, another example of Canadians seeking unproven therapies abroad has hit the media.

Alberta businessman Lee Chuckry told CBC News in Manitoba that he spent $34,000 for a stem cell therapy in India only to find his MS got worse and that “I think it’s just a big fraudulent scam.” MS

Chuckry, who has been battling MS for over a decade, was recruited into the stem cell trial by Doug Broeska, founder of a Winnipeg-based company called Regenetek Research. Broeska recruited patients for the the so-called “liberation” therapy pioneered by Italian researcher Dr. Paolo Zamboni in 2008. The treatment, dubbed chronic cerebrospinal venous insufficiency, or CCSVI, involves widening the patient’s neck veins to improve blood flow. The Indian clinical trial combines CCSVI and the injection of stem cells into the veins and spinal column.

In March 2013, Chuckry flew to India for the trial. “It comes to a point of sort of desperation of trying to find the next thing that might help me, so I’m always on the search for that and I came across this,” he told the CBC. But the attacks came back upon his return home. His attempts to get in touch with Broeska about his new MS symptoms were unsuccessful and he received none of the follow-up common in clinical trials, such as MRIs and physical examinations.

According to the CBC, Broeska claimed on his LinkedIn profile that he earned a PhD at the University of Manitoba, but the university could not confirm that and his LinkedIn profile was down yesterday. The International Cellular Medicine Society, of which Broeska claims to be a member, has no record of his membership. And the ethics committee at India’s Inamdar Hospital in India, where the clinical trial is underway, ordered Broeska to step down as principal investigator because his lack of credentials and follow-up “violated international ethical standards.”

In addition, the Winnipeg Free Press reported this morning that the University of Winnipeg has cancelled a joint project with Regenetek Research.

Over the last few years the much publicized potential of stem cells to treat a variety of diseases has raised hope among patients suffering from conditions for which there currently are no cures. This, in turn, has led some less than scrupulous companies across the globe to capitalize on that hope by marketing costly stem cell therapies that do not have the support of proven clinical evidence. For more information, please visit our Treatment Abroad page.

Both the Howe report and this week’s MS controversy point to the need for Canada to make stem cell research and development a national priority. As James Price, Foundation President and CEO, told the Ottawa Citizen earlier this week, “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, with its goal of delivering five to 10 new treatments to clinics within 10 years. He told the paper that the Action Plan will give Canadians confidence “that new therapies are a priority and ultimately, Canadians will have first access to these therapies.”

Indeed, Canada is a world leader in stem cell research. MS survivor Jennifer Molson has been symptom-free for 12 years after receiving a stem cell transplant in a  clinical trial run by Dr. Harry Atkins at the Ottawa Hospital. “I’m living proof of the tremendous potential that exists with stem cell research. I got a second chance at life.” said Molson in declaring her support for the Strategy.

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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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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 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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