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DoD Reconstructive Transplant Research Program Preannouncement

17 May 2022 10:56 AM | Anonymous member (Administrator)

The RTRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities.  This pre-announcement should not be construed as an obligation by the government.

 

The FY22 Defense Appropriations Act is anticipated to provide funding for the RTRP to support research of exceptional scientific merit to refine approaches for and increase access to reconstructive transplants and state-of-the-art immunotherapy.  The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The RTRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities.  This pre-announcement should not be construed as an obligation by the government.  The FY22 RTRP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website.  Pre-application and application deadlines will be available when the announcements are released. 

 

Applications submitted to the FY22 RTRP Investigator-Initiated Research Award must address one or more of the following Focus Areas:

 

Reduce the risks of vascularized composite allotransplantation (VCA)-associated immunosuppression

  • Define the unique manifestations and/or mechanisms of VCA immunogenicity
  • Develop novel approaches for achieving VCA immune tolerance
  • Develop less-toxic and/or personalized regimens for maintenance immunosuppression
  • Identify unique immunosuppression requirements for VCA compared to other solid organ transplants

 

Identify and/ or validate reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring

  • Identify and/or validate reliable non-invasive biomarkers for monitoring acute and chronic VCA graft rejection in human subjects or banked human specimens and medical records suitable for use in the clinic or at home
  • Develop assays or devices for clinical graft monitoring utilizing validated biomarkers

 

Develop VCA-specific outcome measures to include:

  • Measures of clinical outcomes, including but not limited to, graft health and survival, frequency and/or severity of graft rejections, immunosuppression-related toxicity
  • Measures of functional outcomes, including but not limited to, neuromusculoskeletal function, range of motion, resolution of phantom limb pain
  • Measures of social outcomes, including but not limited to, activities of daily living, return to work, community integration, VCA-specific quality of life measures

 

Applications submitted to the FY22 RTRP Advanced Technology Development Award must address one or more of the following Focus Areas:

 

Advance existing tissue preservation strategies to extend the timeline between procurement and transplantation

  • Develop promising approaches and technologies for translation to the clinic, including but not limited to, perfusion, hypothermic, high-subzero and low-subzero, or static preservation strategies
  • Determine the extent to which VCA tissue preservation technology impacts VCA immunogenicity

 

Advance reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring

  • Validate reliable non-invasive biomarkers for monitoring acute and chronic VCA graft rejection in a human model or banked human specimens and medical records
  • Develop assays or devices for clinical implementation of graft monitoring utilizing validated biomarkers

 

Applications submitted to the FY22 RTRP Concept Award must address one or more of the following Focus Areas:

 

Reduce the risks of VCA-associated immunotherapy

  • Define the unique manifestations and/or mechanisms of VCA immunogenicity
  • Develop novel approaches for achieving VCA immune tolerance
  • Develop less-toxic and/or personalized regimens for maintenance immunosuppression
  • Identify unique immunosuppression requirements for VCA compared to other solid organ transplants

 

Identify reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring

  • Identify new peripheral biomarkers for acute and chronic VCA graft rejection in human subjects or banked human specimens and medical records suitable for use in the clinic or at home
  • Develop assays or devices for clinical implementation of graft monitoring utilizing validated biomarkers

 

Applications submitted to the FY22 RTRP Clinical Network Award must address the standardization, assessment, and validation of protocols and/or clinical practice guidelines (CPGs) for each of the following aspects of VCA for face and hand transplantation:

  • Patient inclusion/exclusion criteria
  • Patient education
  • Surgical procedures
  • Immunosuppression and/or immunoregulation
  • Outcome metrics
  • Quality-of-life measures
  • Rehabilitation
  • Patient reporting (e.g., registry)

 

Press Release: 2022 Reconstructive Transplant Research Program, Congressionally Directed Medical Research Program (army.mil)

 

Investigator-Initiated Research Award

Independent investigators at all academic levels (or equivalent)

·      Supports studies with the potential to make an important contribution to the reconstructive transplant research field, patient care, and/or quality of life.

·      Preproposal is required; full application submission is by invitation only.

·      Applications must address at least one of the FY22 RTRP Investigator-Initiated Research Award Focus Areas.

·      Preliminary or published data are required for all Focus Areas.

·      Multiple PI Option:

·      Supports synergistic partnerships among two to four investigators collaborating on a single application.

Single PI:

·        Maximum funding of $1 million (M) for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

Multiple PI Option:

·        Maximum total funding of $1.5M for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

 

Advanced Technology Development Award

Independent investigators at all academic levels (or equivalent)

·      Supports research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation.

·      Applications must address at least one of the FY22 RTRP Advanced Technology Development Award Focus Areas.

·      Preproposal is required; full application submission is by invitation only.

·      Preliminary or published data are required.

·      Multiple Principal Investigator (PI) Option:

Supports synergistic partnerships among two to four investigators collaborating on a single application; multi-institutional collaborations are encouraged.

Single PI:

·        Maximum funding of $1M for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

Multiple PI Option:

·        Maximum total funding of $1.5M for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

 

Concept Award

Independent investigators at or above the level of postdoctoral fellow (or equivalent)

·      Pre-Application (Letter of Intent) is required.

·      Supports the exploration of a highly innovative new concept or untested theory that addresses an important problem relevant to reconstructive transplantation.

·      Preliminary data are NOT allowed.

·      Reviewers at both tiers of review will be blinded to the identities of the PI, collaborators, and their organizations.

·      Applications must address at least one of the FY22 RTRP Concept Award Focus Areas.

·      Maximum funding of $200,000 for total costs (direct plus indirect costs).

·      Maximum period of performance is 18 months.

 

Clinical Network Award

Independent investigators at or above the level of Assistant Professor (or equivalent) are eligible to be named PI.

·      To promote a major multi-institutional network of VCA Centers and associated collaborators for the purpose of standardizing clinical protocols and CPGs for face and hand transplantation, as well as assessing and validating those protocols and CPGs in multi-institutional clinical trials.

·      This effort will be executed through a two-phase 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.

·      Phase 1 Objectives

       Establish the Clinical Network

       Develop standardized protocols and Standard Operating Procedures

       Develop clinical trial applications

       Coordinate external Peer Review

       Obtain all regulatory approvals

·      Phase 2 Objectives

       Conduct clinical trials (one for face transplantation and one for hand transplantation)

       Submission of a Letter of Intent is required prior to full application submission.

Phase I:

  • Maximum funding of $3M for total costs (direct plus indirect costs) to the Coordinating Center.
  • Maximum period of performance is 2 years.

Phase II:

  • Maximum funding of $10M for total costs (direct plus indirect costs) to the Coordinating Center.
  • Maximum period of performance is 4 years.

 

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final funding opportunity announcements that will be available for downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

 

Submission deadlines are not available until the funding opportunity announcements are released.  For email notification when announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the RTRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

 

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil



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