The International Society for Stem Cell Research (ISSCR), the world's leading professional organization of stem cell researchers, released new guidelines for the responsible development of safe and effective stem cell therapies for patients.
A commentary article that summarizes the guidelines for the clinical translation of stem cells will be published in the December issue of Cell Stem Cell, the official affiliated journal of ISSCR.
These guidelines define a roadmap for medical researchers and doctors, outlining what needs to be accomplished to move stem cells from promising research to proven treatments for patients. The new guidelines will accelerate the translation of stem cell research into practice while addressing associated scientific, clinical, regulatory, ethical and social issues. Founded on core principles of scientific rigor and ethical conduct, the recommendations offered in the guidelines include an insistence on expert evaluation and independent oversight, a thorough informed consent process to provide patients with essential information on the unique aspects of stem cell-based treatments, and transparency in reporting of clinical trial results.
"Our guidelines will arm patients and their doctors with the information they need to make decisions about whether to seek stem cell treatments," said Dr Olle Lindvall, co-chair of the ISSCR task force that developed the guidelines and professor in clinical neurology at the University of Lund, Sweden. "Stem cell research holds tremendous promise for the development of novel therapies for many serious diseases. However, as clinicians and scientists, we recognize an urgent need to address the problem of unproven stem cell treatments being marketed directly to patients."
Too often rogue clinics around the world exploit patients' hopes by offering unproven stem cell therapies, typically for large sums of money and without credible scientific rationale, oversight or patient protections.
The ISSCR's new guidelines establish standards that can be used to judge the claims made by stem cell clinics and whether the treatments they offer are being developed responsibly. ISSCR urges governments and regulatory bodies to enact the recommendations outlined in these guidelines. The guidelines call for countries without an official regulatory body to develop a way to monitor new stem cell-based treatments, and ISSCR has offered to advise agencies that want to build these regulatory capacities.
"Regulators have a responsibility to prevent exploitation of patients in their jurisdictions, and where necessary, to close fraudulent clinics and take disciplinary action against the doctors involved," said Dr George Q Daley, immediate past-president of the ISSCR and associate director of the Stem Cell Program at Children's Hospital Boston.