Patients hoping to learn more about the credibility of clinics selling stem cell treatments abroad will soon have new information to help them make important and often costly decisions regarding their health. A report released today by the Task Force on Unproven Stem Cell Treatments, convened by the International Society for Stem Cell Research (ISSCR) outlines criteria by which people can evaluate the claims made by the hundreds of so-called "rogue" clinics operating across the globe.
Such treatments can cost patients in excess of $40,000, with no guarantee of efficacy or safety, and often with little or no follow-up on the part of the clinic. Current data suggests that as many as 5,000 of these treatments have already been conducted by the largest of these clinics.
The ISSCR report recommends that each clinic be evaluated based on:
1. Whether it has obtained Research Ethics Board approval in its jurisdiction, and 2. Whether it has been approved by an internationally-recognized National Oversight Body in its country of operation.
The Task Force further stressed the importance of sound scientific grounding before starting trials and clinics being assessed for the above criteria will be invited to submit published papers documenting their research and data.
"It is well documented that many of these clinics make claims of cures or treatments in the absence of any scientific evidence. In some cases, not only do we not know what kinds of cells are being administered to patients, we have little indication of any real benefit or, more importantly, harm from the procedures," says Stem Cell Network investigator Timothy Caulfield, Director of the Health Law Institute at the University of Alberta. "In terms bringing a measure of accountability and transparency to the issue of stem cell tourism, the ISSCR initiative is an important first step."
The Task Force was comprised of world-leading researchers and experts in the stem cell field, including representation from Canada. With the release of today's report, the ISSCR has announced plans to provide a publicly accessible forum, via web site, where patients and other interested parties may obtain a list of those clinics that fail to meet the criteria set out in the report. In addition, patients may submit the name of a clinic for evaluation by the ISSCR. The web site (www.closerlookatstemcells.org) is expected to start listing clinics later this year.
"The false claims and unscrupulous methods through which some clinics attract patients has quickly become one of the most important concerns facing the field today," says Drew Lyall, Executive Director of the Stem Cell Network and one of the authors of the report.
"Researchers have made great advances toward the clinical application of stem cells, however, for many diseases we haven't yet put all the pieces of the puzzle in place. This report and web initiative is a reminder of the real risks that exist for those who choose to participate in what is still considered experimental medicine, and the ethical safeguards, regulatory oversight, and scientific evidence patients have a right to expect." says Lyall.
Patient advocacy groups have also praised today's announcement. "Our offices across the country receive inquiries about treating Parkinson's through stem cell therapies," reports Joyce Gordon, President & CEO of Parkinson Society Canada. "Patients want to know whether the treatment offered by overseas clinics is effective and worth the cost. Since Parkinson's is one of the diseases unsupported by clinical evidence for these treatments, the new resource will provide more critical information so people can evaluate the claims by overseas clinics."
The new evaluation web site complements the Patient Handbook on Stem Cell Therapies, which was published in 2008 by the ISSCR to serve as an outline on the basics of stem cell therapies and clinical trials and provides some key considerations and questions for patients. The Handbook was translated into French for Canadian audiences by the Stem Cell Network earlier this year.
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