The ISSCR today condemned unproven stem-cell treatments that are not designed to learn and report information and that are conducted without oversight, particularly if patients are charged for advertised medical services. Originally a task force within the ISSCR was supposed to release a draft of guidelines on Thursday. After disagreements about how specific the guidelines should be and how stringent a tone to take, the group decided instead to announce over-arching principles at its annual meeting.
The ISSCR particularly condemns giving unproven treatments that are advertised as medical services for paying patients. In fact, instead of stem-cell treatment, the preferred term is “stem-cell based intervention” because the term “treatment” denotes benefit.
The guidelines will be very broad, basically laying out how to decide when stem-cell product is ready to be tested in people. They will cover how cells should be processed and characterized, what pre-clinical evidence should be collected, how strong the case against risk and for benefit should be, how patients should be informed. They should also consider who research stands to benefit society as a whole.
“This is not based on science; it is not based on clinical judgment,” Olle Lindvall, co-chair of the task force that drew up the guidelines said, speaking of clinics that lure patients with promises to cure all manner of disease. This leaves a big gray area of clinicians who are charging patients but also documenting their work and occasionally publishing their research. While acknowledging controversy, task members think that some clinicians are naïve about the information that can be gleaned from preclinical work and are moving from mice to humans too quickly
After the presentation, many questioners asked about inclusion. Attendees asked about the nationalities of task force members, whether anyone was communicating with China, and noted that clearly dangerous treatments (injecting rabbit cells in people) were happening even in countries like the UK. They asked how much the task force was communicating with
Lindvall said that the task force represented 13 countries (including China), and Insoo Hyun, also co-chair of the task force, said a chief purpose of this meeting was to collect as much feedback as possible. When asked whether clinicians and scientists that did not adhere to the guidelines would be barred from membership in the ISSCR, Lindvall said that that had not been discussed.
One question is whether these guidelines will be useful, since the ISSCR does not have regulatory authority. However, task force members seemed to think that many regulatory agencies would welcome their guidelines and adopt them as policy. At a separate session, Angela McNab, who helped set UK regulation around human embryonic stem cell research, said she thought that the guidelines could get unregulated governments to move a bit faster; they could also help researchers in unregulated countries set best practices.
I blogged from one of the earlier meetings of the task force.