A study in Cell Stem Cell finds that web sites that offer stem cell treatments over the Internet make lots of bogus claims, and the leading organization of stem cell scientists has issued a patient handbook of questions to ask potential providers, plus guidelines for the clinical translation of stem cells.
We have an excellent commentary that explores the issue from the view of various stakeholders including patients, providers, regulators, and scientists. It’s written by Doug Sipp of RIKEN in Japan and Sorapop Kiatpongsan of Harvard and Thailand’s Chulalongkorn University. Here is the NatureNews story.
This feature charts dilemmas faced by practitioners and patient advocates.
This news story includes opinions from diverse members of the task force and others in the community.
Links to a story in the popular press and a draft of a news story is below.
Here’s U.S. News and World Report
Worried that profit-hungry quacks are exploiting patients and endangering clinical research by offering risky stem-cell procedures, the International Society for Stem Cell Research (ISSCR) has published documents to both warn patients away from “fraudulent clinics” and spur government authorities to shut them down.
The society condemned ‘stem-cell tourism’ earlier this year, when it began soliciting public comments for the guidelines. In an article1 accompanying the announcement [of the guidelines],2 Timothy Caulfield of the University of Alberta examined websites of clinics that advertise their services directly to consumers. Offerings included stem-cell treatments for autism, Parkinson’s disease, and spinal cord injury, with an average cost of $21,500. Caulfield’s article describes the claims as “optimistic” and “unsubstantiated by the peer-reviewed literature.”
Many clinics operate under a lax regulatory environment in China, Thailand, India, Russia, the Caribbean, and Latin America, and researchers complain that few of these clinics provide details of their procedures.3 The new ISSCR handbook provides a list of questions patients should ask future practitioners, such as whether the treatment is considered routine and what evidence has been collected. It also warns against clinics that offer only testimonials as evidence and treat many unrelated diseases, particularly with the same cells. Right now, many clinics won’t even tell scientists what kinds of cells they are using, says Insoo Hyun, a bioethicist at Case Western University and co-chair of the committee that helped write the guidelines.
The guidelines acknowledge that, sometimes, “clinicians may be justified in attempting medically innovative stem-cell based interventions in a small number of their seriously ill patients,” but in such cases, they should be moving toward a clinical trial. Practitioners should also describe how they will characterize and administer cells, submit a plan for the procedure to independent experts, and disclose patients’ fates.
Additionally, guidelines detail how informed consent should be obtained from patients and tissue donors, the kind of animal studies that could provide evidence that a clinical trial should go forward, and how patients should be monitored during and following a trial.
“What they are asking for is what we already do [anyway],” says Rich Burt, who leads clinical trials involving adult stem cell transplants at Northwestern University and was not involved with drafting the study.
That response would please Hyun, who says that the goal was to document the consensus of the mainstream scientific community, the better to distinguish shady clinics from legitimate ones. “We now have something we can point to [in order] to say that the clinics fall short,” he says.
The members of the task force drafting the guidelines represent 13 countries, and they were able to interact with their respective governments and gain feedback from other groups working to move stem cells into the clinic. “I really don’t think it’s a task force product,” says Hyun, “It’s been examined by key stakeholders internationally.”
Olle Lindvall, a professor of neurology at Lund University in Sweden, and head of the task force, admits that right now the 40 guidelines are more over-arching principles than an operational handbook. (In fact, one of the guidelines is that the guidelines be regularly reviewed.) “They focus on general aspects of how to prepare the cells and to test the cells in animal models, aspects of informed consent and peer review and social justice.” The types of regulations and considerations for demonstrating safety and efficacy should vary depending on how much cells are manipulated, whether a patient receives his own cells or those from a donor, and even what other options for treatment a patient may have access to, says Lindvall. Different diseases will require different considerations, and the goal of these recommendations, says Lindvall, is to provide a starting point for moving more cells into the clinic. “Now we can sit down with our colleagues.”
“I don’t think that the details are as important as the principles of trying to weigh the risks and benefits,” says Marie Csete, chief scientific officer of the California Institute of Regenerative Medicine.
Lindvall doubts that these guidelines will cause clinics operating outside the scientific mainstream to reform: “More of the clinics are interested in making money than in helping patients.” Instead, he says, “we hope that governments and regulatory bodies will act so that these clinics will have to close.”