Volumetric Muscle Loss (VML) Repair Following Extremity Trauma

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Materiel Development Activity (USAMMDA). The award(s) will be managed by the Combat Trauma and Acute Rehabilitation Project Management Office (CTAR PMO) in support of the Extremity Injury Repair – Muscle (EIR-M) effort at USAMMDA. The EIR-M Integrated Product Team (IPT) will provide consultative input into the project as needed, and conduct annual inprogress reviews with the Milestone Decision Authority, as well as interim reviews if needed more frequently.

The goal of this research is to develop an off-the-shelf biologic prototype capable of preventing, mitigating, or treating traumatic large-volume muscle loss (VML) injuries of the extremities. While such injuries are devastating, irreversible, and uniformly associated with long term disability, recent advances in regenerative medicine have made new approaches possible.

The Government seeks to assess the potential for repurposing products already commercially available or in clinical development for related indications, such as critical limb ischemia, iatrogenic muscle injuries, Duchene’s muscular dystrophy, compartment syndrome, and severe sports medicine injuries. Products capable of regenerating or repairing multiple tissue types or creating a therapeutic wound environment will also be considered.

Note: The repurposed product must be an existing product with demonstrated clinical benefit for at least one related skeletal muscle disorder indication. At least one successful FDA-regulated Phase 2 clinical trial should have been completed at Technology Readiness Level 7 (TRL 7). In addition, the product should have a plausible mechanism for benefit in VML injuries.

Scope of Work

To be provided initially by the Offeror at the time of submission. Submitted information is subject to change through negotiation if the Government selects for funding.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.