21st Century Cures Act: Regenerative Medicine Initiative
Active
- Assistance listing
- 93.370
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Grant awards
- 23 $40,759,634 in federal obligations
Program facts
- Also known as
- Regenerative Medicine Initiative
- Assistance types
-
- Cooperative Agreement
- Project Grant
- Treasury account
-
- 75-2018-0-0-028
Program details come from SAM.gov Assistance Listings. Updated . Grant award figures come from USAspending.gov.
About this program
The Department of Health and Human Services National Institutes of Health is funding clinical-stage and preclinical regenerative medicine therapies through the 21st Century Cures Act: Regenerative Medicine Initiative (CFDA 93.370), with the most recent grant award dated September 15, 2023.
The program funds development and translation of cell-based and tissue engineering therapies across multiple disease areas. Recent awards demonstrate substantial focus on mesenchymal stromal cell (MSC) therapies for pancreatitis and pain management, stem cell-derived therapies for ocular conditions including corneal scarring and age-related macular degeneration, iPSC-based treatments for rare genetic skin disorders and cardiac disease, tissue-engineered vascular grafts for congenital heart surgery, and extracellular vesicle therapies for cardiovascular repair. The portfolio includes preclinical manufacturing validation, early-phase clinical trials, and phase 1/2a clinical testing.
Grant awards are predominantly Cooperative Agreements (96 percent of 23 total awards) with a single Project Grant, reflecting the program's emphasis on collaborative translational work. The National Institutes of Health Office of the Director is the sole funding entity across all 23 awards documented in the portfolio. Combined federal obligation stands at $40.8 million across the award set, with combined total obligation (including non-federal cost-share) reaching $44 million. Recent award magnitudes range from approximately $298 thousand to $10.4 million, with most clustered between $500 thousand and $2.5 million.
Award activity shows eight grants in 2023 (the most recent cycle documented), five in 2020, and declining volume in 2021 (two awards). The program demonstrates sustained activity from its inception in 2019 through September 2023. Representative recent awards include mesenchymal stem cell therapy for chronic pancreatitis pain ($2.3 million, September 2023), human corneal stromal stem cells manufactured to GMP standards for corneal scarring ($2.6 million, September 2023), induced pluripotent stem cell therapy for recessive dystrophic epidermolysis bullosa delivered via spray device ($538 thousand, September 2023), and tissue-engineered vascular grafts for pediatric congenital heart surgery ($10.4 million, September 2019).
No open grant opportunities are currently posted in the source material. The program does not specify a next application deadline or recent solicitation activity.
Objective and description
- Objective
To provide support for initiatives funded under the 21st Century Cures Act to support the BRAIN Initiative's aim of revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, rese
Eligibility
- Applicant eligibility
The awardee will be a university, college, hospital, public agency, nonprofit research institution or for-profit organization that applies and receives a grant for support of research by a named principal investigator. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council.
- Beneficiary eligibility
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
- Credentials and documentation
Applications must be submitted in compliance with instructions provided with each initiative.
- Uses of assistance
Grants and cooperative agreements may be made to eligible institutions for the support of the BRAIN Initiative. The grants and cooperative agreements may be used for personnel, consultant costs, equipment, supplies, travel, patient costs, animals, alterations and renovations, miscellaneous items, and Facilities and Administrative Costs (formerly known as indirect costs).
- Length and time phasing of assistance
Grants and Cooperative Agreements: Average 3 to 5 years, and a maximum of 5 years. Renewals may be awarded for additional periods of up to 5 years based on competitive peer review.
How to apply
- Award procedure
Grants and cooperative agreements are funded based on scientific merit, program relevance, and program balance and are made annually. The initial grant award provides funds for the first budget period (usually 12 months) and letter Notice of Award indicates support recommended for the remainder of the project period, allocation of Federal funds by budget categories and special conditions, if any.
- Time to approval or disapproval
Regular Grants: Approximately 10 months
- Renewals
Applications submitted for renewal are reviewed and selected for funding on a competitive basis.
- Appeals
A principal investigator may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/notice-files/not97-232.html .
Grant awards
Latest 10 of 23 listed here. See the rest on GovTribe.
Top recipients by federal obligations
| Rank | Recipient | Federal obligations | Share |
|---|---|---|---|
| 1 | Research Institute At Nationwide Children's Hospital | $8,278,202 | 20% |
| 2 | The Johns Hopkins University | $6,325,294 | 16% |
| 3 | Regenerative Research Foundation | $4,792,432 | 12% |
| 4 | Steadman Philippon Research Institute | $4,030,969 | 10% |
| 5 | The Medical University Of South Carolina | $2,700,822 | 7% |
| 6 | University Of Illinois | $2,601,656 | 6% |
| 7 | University Of Pittsburgh - Of The Commonwealth System Of Higher Education | $2,564,108 | 6% |
| 8 | Trustees Of Boston University | $1,960,412 | 5% |
| 9 | Wake Forest University Health Sciences | $1,586,297 | 4% |
| 10 | The Regents Of The University Of Colorado | $1,345,788 | 3% |
10 of 16 recipients listed here. See the rest on GovTribe.
Federal obligations by fiscal year
| Fiscal year | Federal obligations |
|---|---|
| FY2026 | $3,837,362 |
| FY2025 | $1,723,544 |
| FY2024 | $9,808,970 |
| FY2023 | $6,632,255 |
| FY2022 | $4,768,395 |
| FY2021 | $4,620,327 |
Quick answers
What is Assistance Listing 93.370?
Assistance Listing 93.370 is 21st Century Cures Act: Regenerative Medicine Initiative, a federal grant program run by National Institutes of Health (Department of Health and Human Services).
What is the CFDA number for 21st Century Cures Act: Regenerative Medicine Initiative?
Its CFDA number is 93.370: Assistance Listing numbers were called CFDA numbers before 2018.
How much funding has Assistance Listing 93.370 awarded?
23 grant awards under 93.370 have obligated $40,759,634 in federal funds to 16 recipients.
Who receives the most funding from 93.370?
The recipients obligated the most under 21st Century Cures Act: Regenerative Medicine Initiative are Research Institute At Nationwide Children's Hospital ($8,278,202), The Johns Hopkins University ($6,325,294) and Regenerative Research Foundation ($4,792,432).
How much did 93.370 obligate in fiscal year 2025?
Grants under 93.370 obligated $1,723,544 in federal funds in fiscal year 2025.
On GovTribe
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