DoD Reconstructive Transplant, Clinical Network Award | W81XWH 20 RTRP CNA

Opportunity Information: Apply for W81XWH 20 RTRP CNA

The DoD Reconstructive Transplant, Clinical Network Award (RTRP CNA; Funding Opportunity Number W81XWH-20-RTRP-CNA) is a Department of Defense funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Reconstructive Transplant Research Program (RTRP). Its core purpose is to build a large, multi-institutional clinical network focused on vascularized composite allotransplantation (VCA), specifically face and hand transplantation. The program is trying to move these procedures closer to routine clinical care by doing something the field has struggled with: aligning major VCA centers around shared, standardized clinical protocols and standard operating procedures (SOPs), then testing those agreed-upon approaches in coordinated, multi-site clinical trials. The underlying rationale is that broad consensus and multi-center evidence are essential steps for shifting face and hand transplantation away from being treated as purely experimental and toward being considered a viable option that could ultimately support payer and insurance reimbursement.

The award is structured as a single, two-phase effort centered on one funded entity: the Clinical Network Coordinating Center. Rather than funding many separate stand-alone projects, DoD intends to fund one Coordinating Center that becomes the operational hub for the entire Clinical Network. This hub is expected to handle the day-to-day backbone work that makes a multi-institutional program function: administrative coordination, operational support, data management, and overall execution so Network activities move on schedule. Strategic guidance and oversight come from the RTRP Clinical Network Steering Committee, which includes the RTRP Programmatic Panel, program staff, and other key USAMRDC personnel. In practice, the Coordinating Center runs the network, but it does so under Steering Committee direction, with major decisions and progression through phases tied to that oversight.

Phase I lasts up to 2 years and is essentially the build-and-launch stage. It has five main objectives. First, the Coordinating Center must establish the Clinical Network by working with the Steering Committee to invite VCA Centers and other necessary collaborators to participate as Network Sites via subawards. An important detail is that the Network Sites are not included in the initial application itself; the Coordinating Center is selected first, and then the broader network membership is built after award. The network is expected to include as many face and hand VCA centers as possible and to bring in additional collaborators as needed so the network collectively covers the expertise required across RTRP focus areas. Second, the network must develop standardized protocols and SOPs for both face and hand transplantation. The Coordinating Center is responsible for setting up the structure and collaborative environment that allows participating sites to work as equal partners toward harmonized, consensus-driven clinical procedures. Third, the Coordinating Center and Network Sites must produce two full clinical trial applications: one for face transplantation and one for hand transplantation, each grounded in the standardized protocols and SOPs developed by the network. Fourth, the Coordinating Center must arrange and pay for an external scientific peer review of both trial applications, then submit those peer review results to the Steering Committee for assessment. Fifth, Phase I must secure required regulatory approvals, including any approvals needed from the U.S. Food and Drug Administration (FDA). After the Steering Committee authorizes moving forward, the standardized protocols and SOPs and the reviewed trial plans must go to a single unified Institutional Review Board (IRB) of record, and then to the USAMRDC Human Research Protection Office (HRPO) for final human-subjects protections review and approval.

Funding for Phase I is capped at $3 million in total costs to the Coordinating Center over the 2-year period of performance. The Coordinating Center is also expected to manage funds flowing to Network Sites through subawards and to support other key collaborators as necessary, meaning the award is not just paying for the lead organization but for the coordination and resourcing of the full network it assembles. Phase II is an option period, not guaranteed, and depends on both successful completion of Phase I objectives and the availability of funds. The single Phase II objective is to conduct the clinical trials: one multi-institutional face transplantation trial and one multi-institutional hand transplantation trial designed to assess and validate the standardized protocols and SOPs created in Phase I. Participating VCA Network Sites will serve as enrollment sites for one or both trials depending on whether they specialize in face transplantation, hand transplantation, or both.

From an applicant and administrative standpoint, the opportunity was categorized as discretionary funding, with funding instruments listed as cooperative agreement and grant, reflecting DoD’s expectation of substantial programmatic involvement and coordinated execution rather than an arms-length research award. Eligibility was described as unrestricted (open to any entity type, subject to any additional eligibility text). Only one award was expected, reinforcing that DoD wanted a single Coordinating Center to unify and drive the field toward consensus standards and produce multi-site clinical evidence. The original posting timeline shows a creation date of September 25, 2020, and an original closing date of December 3, 2020, and it is listed under CFDA 12.420 (military medical research and development).

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Reconstructive Transplant, Clinical Network Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Sep 25, 2020.
• Applicants must submit their applications by Dec 03, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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