The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells.
Donor Name: National Institutes of Health
State: All States
County: All Counties
Type of Grant: Grant
Deadline (mm/dd/yyyy): 09/02/2022
Grant Size: $150,000
Grant Duration: 2 years
Details:
This Funding Opportunity Announcement (FOA) provides support for activities central to the refinement and completion of a study protocol and procedures necessary for implementing clinical trials that explore and enable the development of safe and effective RM interventions using adult stem cells that are not of embryonic or fetal origin with an emphasis on the following areas:
- Potential to catalyze sustained and accelerated development of the RM field through contributing to the knowledge critical for clinical testing, stem cell characterization and authentication, cGMP compliant stem cell production or phase-appropriate GMP and utilization of standards, in vivo stem cell tracking and monitoring, data standards development, and data sharing
- Readiness of the RM product for advancement into clinical trials under an IND/IDE application
- Contribution to the significant advancement of the field of RM by addressing well-recognized challenges in clinical development
- Critical issues relevant to clinical research and regulatory submissions, including those related to improved evaluation of product quality
- Provision of preliminary data, clinical and/or non-clinical study data, or information in the literature or citations regarding mechanism of action that support the scientific rationale and need for the clinical trial to test the proposed hypothesis or intervention
- Contribution to the breadth of RM science
- Use of existing research infrastructure such as clinical trial network(s) where possible
- Contribution to an improved and shared understanding of current technical and operational barriers as well as regulatory science issues in the field of RM and how to overcome them
Funding Information
- Award Ceiling: $150,000
- The maximum project period will be up to 2 years.
Eligibility Criteria
- State governments
- Native American tribal organizations (other than Federally recognized tribal governments)
- Special district governments
- For profit organizations other than small businesses
- Public housing authorities/Indian housing authorities
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Small businesses
- Native American tribal governments (Federally recognized)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- City or township governments
- County governments
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Independent school districts
For more information, visit Grants.gov.
