The International Society for Stem Cell Research (ISSCR; Skokie, IL, USA) has released newly updated guidelines for stem cell research and the development of new clinical therapies, which outline the practices and required for the transparent, safe and efficacious development of stem cell-based therapies.
Following the recent, rapid progress within the stem cell field, including the use of controversial technologies that have raised ethical concerns, such as gene editing in human embryos and human—animal chimeras, and the ever-increasing number of clinical trials utilizing stem cell-based therapies, the International Society for Stem Cell Research (ISSCR; Skokie, IL, USA) has released an update to its Guidelines for Stem Cell Science and Clinical Translation. The document the principles and practice stem cell scientists should adhere to order for their work to remain transparent, ethical and 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,” explained Dr Sean J Morrison, ISSCR president and director of the Children’s Medical Center Research Institute at UT Southwestern (Dallas, TX, USA). “These guidelines are essential to protect the integrity of the research and to assure that stem cell treatments are safe and effective.”
A task force of 25 scientists, ethicists, and experts in healthcare policy from nine countries, and chaired by bioethicist Dr Jonathan Kimmelman (McGill University, MontrÃ©al, QC, Canada), updated and expanded an earlier set up guidelines developed by the ISSCR in 2006 and 2008, with key topics being research integrity, patient welfare, respect for research subjects, transparency and social justice. They reiterate the need for specialized oversight process for research involving human embryos, and for rigor on all stages of the research. The guidelines also address the cost of regenerative medicine products, and emphasize the need for accurate and effective public communication.
“By addressing ethical uncertainties, articulating standards, and protecting patients and the public interest, these guidelines provide a path for rapid advances in stem cell biology and medicine,” said Kimmelman. “Science moves quickly, and we recognize the guidelines are a living document that will undergo ongoing review, interpretation, and revision in order to support the community.”
Although these guidelines provide professional standards for the responsible conduct of research that governments and institutions should consider for their stem cell research policies, the dynamic and fast-changing nature of the stem cell field requires constant discussion of these topics and review of the correct standards.