The National Institutes of Health (NIH) and participating NIH Institutes and Centers (ICs) and the U.S. Food and Drug Administration (FDA), through this Funding Opportunity Announcement (FOA), invite revision applications from investigators with active R01 Research Project awards that will support clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. A competing revision is a request for an increase in support in a current budget period for expansion of the project's approved scope or research protocol. These revision applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective regenerative medicine therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of product manufacturing, quality, safety, or effectiveness.
Toward these ends, the NIH will consider applications for clinical research involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of a pre-Investigational New Drug (IND) or pre-Investigational New Device Exemption (IDE) package; the submission of an IND/IDE application; or to support such research conducted under an authorized IND or IDE.
This FOA will use the R01 activity code and will thereby support a discrete, specified, circumscribed research project.