The RTRP seeks to promote a major multi-institutional network of VCA Centers and associated collaborators for the purpose of standardizing clinical protocols and SOPs for face and hand transplantation, and assessing those protocols in multi-institutional clinical trials.

It is the intent of

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the RTRP to bring together investigators from as many VCA Centers for both face and hand transplantation as possible to establish a consensus in the field of reconstructive transplantation for these protocols and SOPs.

The RTRP recognizes that such a consensus is a necessary first step to advancing face and hand transplantation from experimental status to that of a viable choice with the potential for reimbursement under health insurance policies.

This effort will be executed through a two-phased approach in the form of a single award to the Clinical Network Coordinating Center.

The Coordinating Center will serve as the Clinical Network information and planning nexus, providing administrative, operational, and data management support services to implement Clinical Network activities in a timely manner.

Guidance and oversight of the Clinical Network will be provided by the RTRP Clinical Network Steering Committee, composed of the RTRP Programmatic Panel, program staff, and other key U.

S.

Army Medical Research and Development Command (USAMRDC) personnel.

Phase I Phase I of the award will consist of five key objectives:
• Establish the Clinical Network:
Once awarded, the Coordinating Center must work with the RTRP Clinical Network Steering Committee to invite VCA Centers and other collaborators into the Clinical Network as subawards to serve as Network Sites.

(Network Sites will not be included in the application itself.) The Clinical Network must be representative of both face and hand transplantation and include as many VCA Centers as possible, as well as other collaborators as necessary to adequately include expertise across all RTRP Clinical Network Focus Areas.

• Develop Standardized Protocols and SOPs:
The Coordinating Center will establish a framework and collaborative environment for the Clinical Network within which the Network Sites will work as equal partners to meet the goals of standardizing protocols and SOPs for both face and hand transplantation.

• Develop Clinical Trial Applications:
The Coordinating Center will work with the Network Sites to develop one clinical trial application for face transplantation and one clinical trial application for hand transplantation utilizing the standardized protocols and SOPs.

• External Peer Review:
The Coordinating Center will be responsible for coordinating and funding an external scientific peer review of the two clinical trial applications developed under Phase I of the award.

Results of the peer review will then be submitted to the RTRP Clinical Network Steering Committee for assessment.

• Regulatory Approval:
Any regulatory approvals required by the U.

S.

Food and Drug Administration (FDA) must be obtained during Phase I.

Upon approval to proceed with the scientifically reviewed clinical trials from the RTRP Clinical Network Steering Committee, the standardized protocols and SOPs will be submitted to the single unified Institutional Review Board (IRB) of record for review and, upon approval, then submitted to the USAMRDC Human Research Protection Office (HRPO) for review and approval.

The period of performance for Phase I is 2 years, with maximum funding of $3 million (M) in total costs to the Coordinating Center.

The Coordinating Center will manage funding to the Network Sites as subawards and for other key collaborators.

RTRP funding for the Phase II option is contingent on successful completion of Phase I objectives and on available funding.

Phase II The Phase II option of the award, pending availability of funds, will have one key objective:
• Conduct Clinical Trials:
The Clinical Network will expand upon the successful development of standardized protocols and SOPs for both face and hand transplantation by assessing and validating them in multi-institutional clinical trials (one for face transplantation and one for hand transplantation).

Network Sites with VCA Centers will serve as enrollment sites for at least one of the clinical trials, depending on its specialty in face and/or hand transplantation.