Stem cells hold tremendous promise for the development of new treatments for many serious diseases and the ISSCR is optimistic that ongoing stem cell research will lead to effective new therapies. Yet, most potential stem cell treatments are still highly experimental and require more research before they can be offered safely and effectively to patients outside of a clinical trial. The range of diseases where stem cell treatments have been shown to be beneficial in rigorously conducted clinical trials is still limited. The ISSCR is concerned that some stem cell treatments are being prematurely offered to patients without safeguards in place to ensure safety and efficacy.
The Texas Medical Board has proposed changes to its policy concerning the use of investigational agents, with implications for the application of stem cell- and other cell-based treatments. Contrary to preliminary media reports, the ISSCR has not endorsed a position on the draft language. The ISSCR welcomes all efforts that aim to ensure that new stem cell treatments are adequately tested, with appropriate regulatory oversight, and that restrict the inappropriate clinical use of unproven therapies, especially the direct marketing to patients of unproven stem cell-based treatments. In 2008, the ISSCR released professional “Guidelines for the Clinical Translation of Stem Cells” that call for rigorous standards in the development of stem cell treatments, including stringent expert evaluation and oversight of clinical trials, a thorough informed consent process, and transparency in operating and reporting.
The ISSCR emphasizes the critical role that expert independent review and oversight plays in the development and practice of stem cell treatments, and continues to urge regional and federal governments, licensing and regulatory bodies to enact the recommendations outlined in these guidelines.
The International Society for Stem Cell Research is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.