In a strike against 'stem cell tourism', the International Society for Stem Cell Research (ISSCR) officially condemned unproven stem-cell treatments that lack appropriate oversight, patient monitoring, and sufficiently characterized cells. Clinicians should avoid such activities “as a matter of professional ethics,” an ISSCR task force on clinical translation announced at the society's annual meeting in Philadelphia, Pennsylvania, this June. In the next few weeks, the task force plans to release draft guidelines articulating a process for deciding when a potential therapy can be tested in people. The ISSRC is an independent non-profit organization set up to foster stem cell research.

Clinicians and stem cell researchers say they are besieged by enquiries from desperate patients and their families wondering whether to pay thousands of dollars and travel thousands of miles for unproven and possibly unsafe treatments. Society president and Harvard professor George Daley says patients will become more vulnerable as stem-cell science advances. “They will assume the cures are here, and that creates fertile ground for exploitation.” So far, the only established stem cell treatments are bone marrow transplants for some blood diseases.

Wise Young, a neuroscientist at Rutgers University in Newark, New Jersey, has travelled widely to encourage practitioners in countries such as China to collect and share data. He welcomes the guidelines, but says they won't stop the many clinics that are “already violating all the norms of medical ethics by providing false and misleading information.” Nor are guidelines likely to affect what patients do. Many already know the services don't conform to accepted medical criteria, he says. “They go anyway.”

But members on the ISSCR task force charged with drafting the guidelines say it is important to distinguish between those working within and outside scientific norms because well-publicized mishaps in the unregulated arena could tarnish the field. “We need a standard to judge disreputable scientists,” says Angela McNab, who is a task force member but was speaking in a personal capacity. She helped draft UK policies on embryo research as chief executive with the Human Fertilisation and Embryology Authority.

Another, more complicated worry involves practitioners who jump too quickly from animals to humans. Mahendra Rao, vice-president of Invitrogen, and a member of the task force, is concerned that practitioners who use his company's products to prepare cells might imply that the use of certified reagents means that unproven treatments have been validated equally carefully. Insoo Hyun, a bioethicist at Case Western Reserve University in Cleveland, Ohio, and a co-chair of the ISSCR task force, says everyone on the task force has high hopes that stem cells can provide therapies, but they worry about the consequences of rushing. “We don't want to run so fast that we fall.”

The guidelines will cover how cells should be processed and characterized, what pre-clinical evidence should be collected to justify their use in people, what information patients must receive before receiving stem cells or their derivatives, and how treatment effects should be shared and monitored. The guidelines also call on practitioners to consider how their research will benefit society. The ISSCR will not enforce its guidelines or monitor clinics for compliance. Indeed, task-force members had not even considered whether to revoke the membership of practitioners found to be acting outside the guidelines. Instead, the hope is that the guidelines will prompt governments to adopt appropriate regulations and that they will provide a benchmark for those working in less regulated countries.

The draft guidelines were scheduled to be announced on 12 June, but after disagreements among the ISSCR leadership over how harsh a tone to take and how specific to get, the society issued general principles instead. Speaking in a personal capacity, Alok Srivastava, head of Christian Medical College in Vellore, India, and a task-force member, says he hopes the society will reach out to practitioners proactively. The Indian government has funded several large, well-monitored trials, he says. “I don't think there has been any attempt made to get information from these clinics at an international level.”

Hyun says that the task force is actively seeking comments (which can be submitted via the ISSCR website, and that final guidelines should be available by the end of the year.