Clinical Trials in Organ Transplantation in Children and Adults
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for organizations conducting clinical trials in organ and cellular transplantation. Eligible applicants typically include academic medical centers, hospitals, research institutions, and nonprofit organizations with the capacity to conduct multicenter clinical trials. The program focuses on trials in heart, lung, kidney, liver, and intestinal transplantation, as well as cellular therapies and vascularized composite tissue transplantation. Geographic scope is national; applicants anywhere in the U.S. may apply.
Organizations must have expertise in transplantation research and the infrastructure to manage complex, multicenter clinical trials. Previous NIH funding experience and established transplantation programs strengthen competitiveness. The grant supports trials with integrated mechanistic studies examining immune mechanisms.
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Key dates
- Jun 24, 2026 Applications open
- Sep 30, 2027 Application deadline in 441 days
- Jul 1, 2028 Award announced
- Jul 1, 2028 Project start
Program description
The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission through the continued support of the Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) program. The goal of the CTOT-CA is to improve the outcome of organ transplantation through clinical trials with mechanistic studies. The CTOT-CA will support multicenter clinical trials, with associated studies of immune mechanisms, in heart, lung, kidney, liver, and intestinal transplantation. The program will also support clinical trials of non-hematopoietic cellular transplantation as replacement therapies; vascularized composite tissue transplantation; and transplantation of bone marrow or mesenchymal stem cells, or of immunologically active cells, as adjuncts to organ transplantation. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R)
- Project Narrative
- Detailed Budget and Budget Justification
- Biosketches of Key Personnel
- Letters of Support from Collaborating Institutions
- Preliminary Data and Feasibility Documentation
- Data Safety Monitoring Plan (for clinical trials)
Program contact
- 👤 DAIT Transplantation Branch Clinical Trial Leadership
- 📧 CTOT_CA_U01@mail.nih.gov
- 📞 Please contact via email.
Funding track record
Recent awards under CFDA 93.855 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$246,626,852
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$201,437,825
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$185,816,804
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$180,737,624
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$136,265,880
-
$116,817,868
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$93,394,862
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$89,845,851
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$74,456,241
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$72,987,380
Top States by Funding
- CA 8 awards $696.2M
- MA 6 awards $602.8M
- NY 6 awards $335.0M
- TX 3 awards $280.9M
- GA 5 awards $257.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.855). How funding has trended year over year.
| 2024 | $4,073,812,529 | |
| 2025 | $4,378,235,639 | |
| 2026 est. | $4,299,426,996 |
FAQ
Who can apply for this grant?
Academic medical centers, hospitals, research institutions, and nonprofit organizations with transplantation research capacity can apply. Your organization should have experience managing clinical trials and a transplantation program.
What types of trials are supported?
The program funds multicenter clinical trials in organ transplantation (heart, lung, kidney, liver, intestine) and cellular therapies. Trials must include mechanistic studies of immune responses.
Is there a deadline for applying?
The deadline is September 30, 2027. This is a fixed deadline; applications submitted after this date will not be reviewed.
How competitive is this grant?
Very competitive. Applicants should have strong preliminary data, experienced research teams, and realistic timelines. Multicenter collaboration is essential.
What is the funding level?
Specific award amounts vary. The total program pool is approximately $11.28 million. Consult the detailed RFP for award ranges and project duration expectations.
💡 Tips for applicants
- Demonstrate strong preliminary data from your transplantation program. Include baseline outcomes and mechanistic findings to justify the proposed trial.
- Build a robust multicenter consortium. NIAID expects collaborative networks across institutions, not single-center trials.
- Clearly describe how your trial will advance immune mechanism understanding. Mechanistic studies are not optional; integrate them into your trial design.
- Address feasibility and recruitment timelines realistically. Reviewers scrutinize whether you can actually enroll the proposed patient numbers within the funding period.
- Highlight your team's transplantation expertise and track record. Include biosketches of key personnel and prior NIH-funded research in this area.
⚠️ Common mistakes
Applications fail when mechanistic studies are underdeveloped or feel tacked-on. Immune mechanism research must be central to the trial design. Applicants often underestimate recruitment challenges in small transplant populations. Realistic timelines and enrollment strategies are critical. Weak preliminary data or unclear rationale for the trial design signals insufficient preparation.
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