The 21st Century Cures Act, passed in December 2016, establishes a Regenerative Medicine Innovation Project to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for carrying out scientific research and protecting patient safety. For more information about the Regenerative Medicine Innovation Project, visit www.nih.gov/RMI.
On December 6-7, 2017, the NIH and FDA will be hosting a Regenerative Medicine Innovation Workshop at the Bethesda North Marriott & Convention Center. The purpose of the workshop is to explore the state of regenerative medicine science involving adult stem cells with a focus on approaches to the development of safe and effective products. The draft agenda can be viewed at the Materials tab of this website.
With a focus on the development of safe and effective regenerative medicine (RM) products, the workshop will identify critical gaps that must be addressed to enable significant innovation and rapid advancement of RM approaches and will explore issues related to product development and standards, regulatory science, and clinical applications. The framework for sessions in six scientific fields is a set of key questions designed to identify the scientific, technical, and operational challenges as well as to highlight strategies for enabling major transformative advances and the development of clinical applications using adult stem cells. These challenges and opportunities will be explored through the lens of scientific overviews and case studies of clinical science and product development in specific scientific areas that will serve as springboards for in-depth discussions while emphasizing cross-cutting issues with broad applicability to many areas of RM clinical research.