The International Society for Stem Cell Research (ISSCR) – the world’s leading professional organisation of stem cell researchers – have released new guidelines for the responsible development of safe and effective stem cell therapies for patients.
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. They will accelerate the translation of stem cell research into practice while addressing associated scientific, clinical,
regulatory, ethical and social issues.
“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.
“Stem cell research holds tremendous promise for the development of novel therapies for many serious diseases. However, as clinicians and scientists, we recognise an urgent need to address the problem of unproven stem cell treatments being marketed directly to patients.”
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.
The ISSCR also offers a handbook for patients and their doctors evaluating a stem cell therapy. The 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 the 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.
To develop these new guidelines, the ISSCR convened an international task force of experts in stem cell science, clinical research and bioethics from 13 countries.
The task force was led by Dr. Lindvall and Dr. Insoo Hyun, ISSCR member and professor at Case Western Reserve University.
“Our task force has captured the most current, comprehensive thinking on translational stem cell research. The result – these new guidelines – will be valuable for all members of the stem cell community,” said Dr. Fiona Watt, president of the ISSCR.