The International Society for Stem Cell Research (ISSCR), the world’s largest professional organization of stem cell scientists, has released newly updated guidelines for stem cell research and the development of new clinical therapies. The new guidance comes at a time when rapidly evolving technologies like gene editing in human embryos and emerging areas of stem cell discovery and its applications are providing unprecedented opportunities to understand human biology and disease, but also raising questions that have social and ethical implications. The guidelines build on widely shared principles in science that call for rigor, oversight, and transparency in all areas of practice. Adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.
“The field of stem cell research is growing at a rapid pace, with scientists and physicians developing new therapies that can help patients around the world who suffer from a wide variety of conditions,” said Sean J. Morrison, ISSCR president and director of the Children’s Medical Center Research Institute at UT Southwestern. “These guidelines are essential to protect the integrity of the research and to assure that stem cell treatments are safe and effective,” he said.
Anna Veiga, Director of the Stem Cell Bank at the CMR[B], was one of the international authors that participated in the original version called “Guidelines on the Clinical Translation of Stem Cells” (ISSCR, 2008). The 2016 guidelines update and expand those topic areas and bring all guidance together under common principles of research integrity, patient welfare, respect for research subjects, transparency, and social justice.
The new guidelines address several issues not included in previous versions, such as:
• Recognize that the development of increasingly complex in vitro models of early stages of human development should undergo specialized review.
• Highlight opportunities to strengthen preclinical studies in stem cell research, including reproducibility and stringent standards for experimental design.
• Address the valuable contributions made by patients or patient groups to support clinical research and a framework to ensure this is achieved without compromising the integrity of the research.
• Highlight the responsibility of all groups communicating stem cell science and medicine—scientists, clinicians, industry, science communicators, and media—to present accurate, balanced reports of progress and setbacks.
The new guidelines were developed by an international task force of 25 experts in stem cell science, clinical research, and bioethics, from 9 countries, with review and feedback from 85 external individuals and organizations.
The ISSCR 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.