Abstract
Presentation Description :
The 21st Century Cures Act, passed in December 2016, established a Regenerative Medicine Innovation Project (RMIP) 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. The act authorizes $30 million (distributed over fiscal year 2017 through 2020) for the funding of clinical research to further the field of regenerative medicine using adult stem cells. To amplify the benefit of these funds, the Cures Act requires that recipients contribute at least an equal amount of non-Federal dollars or in-kind contributions of non-Federal origin. For fiscal year 2017, Congress allocated $2 million for the RMIP. To make optimal use of these funds, researchers were invited to submit applications for competitive revisions to support clinical studies involving adult stem cells. These awards were made in September 2017. In December 2017, the NIH and FDA hosted a Regenerative Medicine Innovation Workshop in Bethesda, MD. The purpose of the workshop was 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 workshop identified critical gaps that must be addressed to enable significant innovation and rapid advancement of RM approaches and explored issues related to product development and standards, regulatory science, and clinical applications. Six notices were issued in January of 2018 about future funding opportunities that will utilize cooperative agreement funding mechanisms.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.