Cautionary stem cell tourism guidelines came out earlier this month, taking aim at overseas clinics characterized by unsupported expectations, overhyped therapies and uninformed risk.
The new guidelines originated from the
International Society for Stem Cell Research. (Mission statement: “an independent, nonprofit organization … to promote professional and public education in all areas of stem cell research and application.”)
From a press release: “The ISSCR is deeply concerned about the potential physical, psychological, and financial harm to patients who pursue unproven stem cell-based ‘therapies’ and the general lack of scientific transparency and professional accountability of those engaged in these activities.”
In other words, the stem cell field is worried about people getting ripped off or
getting harmed. They are also worried about the bigger picture. This is
from a piece on Bloomberg:
“We’re worried about patients and we are worried about the field,” said
George Daley, a researcher at the Harvard Stem Cell Institute and
member of the task force that wrote the guidelines, in a telephone
interview. “The field is at risk from renegade, illegitimate
practitioners. If there is a public perception that the science isn’t
being done carefully then we’re at risk for losing public support.”Of course anyone considering a trip to India or China or to any of the countries that offer stem cells should read this material and take it seriously.
Of course even though this represents the considerable opinion of the world’s cell biology brain trust, the guidelines may do little to deter those who see no hope in the choices of approved therapies available at home, and who have little patience that the U.S. stem cell promise will be realized any time soon.
I didn’t find much buzz about the latest stem cell caveat emptor at the Internet cure hangouts. The news was pretty well disseminated by the mainstream media, with some pithy headlines, like these:
Beware of Bogus Clinics Offering Stem Cell Cures "Rogue" stem cell clinics exploit hope: reportAn ISSCR team from 13 countries drafted the guidelines over the past year and honed them into two documents,
Guidelines for the Clinical Translation of Stem Cells, which looks at the scientific, clinical, regulatory, ethical and social justice issues that must be ironed out to move basic stem cell research toward clinical applications.
Simultaneously, the group released a consumer-oriented
Patient Handbook on Stem Cell Therapies. This is the one to read if you’re thinking about getting shot up with stem cells – it sets forth a primer on stem cells and their limited use, on how clinical trials work, and asks the questions that must be answered to know whether you are getting an expensive and exploitative experiment or a real therapy.
The ISSCR suggests this checklist for people considering a trip abroad for stem cells. Ask for:
- Evidence of published pre-clinical studies that have been reviewed -- and repeated -- by experts in the field (need it be said, these peer reviewers aren’t allowed to work for the clinic).
- Evidence that the provider has ethical approval from an independent committee (Good luck with this in China or India).
- Evidence that the provider has national or regional regulatory approval. In the UK, this is the European Medicines Agency (EMEA).
The ISSCR warns that certain claims made by providers of stem cell therapies should sound alarm bells:
- Claims based on patient testimonials (this is the basis of all Internet hopefulness; self-reported effects of any treatment are notoriously inconsistent and unreliable).
- Claims that multiple diseases or conditions are treatable with the same cells (there is no cell line or cell cocktail that is the universal treatment for say, Parkinson’s and heart disease).
- Claims regarding the source of cells or treatment details (you might want to know how well screened the cells are for viruses and pathogens – also, where exactly did they come from).
- Claims that there is no risk. Note: there is risk rolling into a foreign clinic; there is risk with any surgery, with any injection.
- High cost treatments or those where the true cost is hidden.
Until the overseas stem cell clinics answer basic questions, they must be considered human laboratories. If the treatments do indeed work, the medical technology must be shared. It’s up to the clinics to make their unsavory reputations go away. Kudos to ISSCR for taking a strong stand.
Mad
