The ISSCR is pleased to announce the release of “Stem Cell Based Clinical Trials: Practical Advice for Physicians and Ethics / Institutional Review Boards,“ a guidebook providing background and fundamental questions for clinicians and institutional review boards to ask when considering running or reviewing early phase, cell-based clinical trials. The guide was developed by practicing physician-scientists and stem cell professionals on the ISSCR’s Clinical Translation Committee.
With stem cell science rapidly progressing toward medical application, the number of clinical trials using stem cell-derived approaches is increasing, yet physicians and ethics / institutional review boards currently have little independent guidance on how to assess them. Stem cell-derived cellular interventions require a unique set of considerations that differ from those used to assess pharmacological drugs, so it’s essential that the physicians that run them and the review boards that approve them are familiar with the appropriate questions to ask. These questions evaluate not only safety, but also to determine whether a trial is well-designed and is based on strong and rational preclinical evidence, and that evidence supports the potential therapy being both safe and ultimately clinically effective and competitive. The guide is meant to help evaluate cellular therapy trials to ensure they are capable of meeting patient needs, regardless of disease area or approach.
Information for patients about stem cell science and its translation to medicine may be found on the ISSCR website, A Closer Look at Stem Cells. The ISSCR is committed to promoting professional and public education in all areas of stem cell research and its application.