by Monya Baker

The ISSCR hopes its handbook will prompt regulators and governments to shut shady clinics

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 has published documents to warn patients away from fraudulent clinics and to spur government authorities to shut the clinics down.

The society condemned stem cell tourism, saying that shady clinics exploit patients' hopes and could jeopardize "legitimate progress of translational stem cell research."1 Researchers worry clinics promote unreasonable expectations for how quickly mainstream work will progress and generate bad publicity that could tarnish the entire field. Patients and patient advocates often express worry that the scientific community is moving too slowly and say patients should be free to try all options.

Timothy Caulfield of the University of Alberta, Canada, examined the 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 and colleagues described the claims as "optimistic" and "unsubstantiated by the peer-reviewed literature."2 Benefits of treatment were overemphasized and risks were underemphasized.

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 procedures3. The new International Society for Stem Cell Research (ISSCR) handbook provides a list of questions that patients should ask their potential 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 that 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 Reserve University in Cleveland, Ohio, and cochair 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. (Copies of the guideline and patient handbook are available at the ISSCR website.)

Additionally, the guidelines detail how informed consent should be obtained from patients and tissue donors, the type 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," says Richard Burt, who leads clinical trials involving adult stem cell transplants at Northwestern University in Evanston, Illinois, 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 and thereby better 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.

"We now have something we can point to [in order] to say that the clinics fall short."

Insoo Hyun
Case Western Reserve University

Caulfield, who was not on the task force, agrees. "Because of the international and multi-jurisdictional nature of this research, it is tremendously difficult to regulate this field. However, I believe the ISSCR guidelines are an incredibly valuable benchmark."

"Ultimately, it is for the local authorities and the medical and scientific community to prevent exploitation of vulnerable patients. The role of the ISSCR is educational and to help with policy," says Alok Srivastava, a physician and scientist at the Christian Medical College in Vellore, India, and a member of the task force that wrote the guidelines.

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."

The ISSCR does not have the authority to regulate, Hyun says, and the society does not have the capacity to evaluate every clinic and protocol. Indeed, the society has not even discussed whether or how to treat people who have joined the ISSCR but participate in shady clinics. (Officials interviewed in June said that they did not know of any such people joining the society.)

Olle Lindvall, a professor of neurology at Lund University, Sweden, and head of the task force, admits that right now the 40 guidelines serve more as overarching principles than as 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 the 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.

"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 for Regenerative Medicine in San Francisco.

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."

But the ISSCR is continuing to work on the issue, says Srivastava. A recently established clinical translation committee will work to prevent exploitation of vulnerable patients, among other goals.


Image Credit: Jessica Kolman

Source: Nature