DoD FY15 Extremity Regeneration Technology/Therapeutic Development Award

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The Fiscal Year 2015 (FY15) Joint Program Committee 8/Clinical and Rehabilitative Medicine Research Program (JPC-8/CRMRP) Extremity Regeneration Technology/Therapeutic Development Award (ERTTDA) is intended to support the translation of promising preclinical findings into products focused on extremity regeneration. The focus is on bone and soft tissue reconstruction, limb and tissue salvage technologies, and regenerative medicine technologies for the treatment of trauma-induced damage. All products in development should be responsive to the health care needs of military Service members, Veterans, and other Military Health System beneficiaries, as well as the general public. All applications must specifically and clearly address the military relevance of the proposed research.The product(s) to be developed may be a tangible item such as a pharmacologic agent (drugs or biologics) or device, or a knowledge-based product such as clinical guidance for standard of care. The Principal Investigator (PI) must provide a transition plan (including potential funding and resources) showing how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the completion of the award.Proof-of-concept demonstrating the potential utility of the proposed product, or a prototype/preliminary version of the proposed product, should already be established. Applicants must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.Examples of the types of research that may be supported include, but are not limited to: Developing and validating clinical guidance/guidelines for standard of care; Testing new therapeutic modalities (agents, delivery systems, and chemical modification of lead compounds) using established or validated preclinical systems; Designing and implementing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials; Developing pharmacologic agents through absorption, distribution, metabolism, excretion, and toxicity (ADMET) studies;Developing pharmacologic agents to Investigational New Drug (IND) stage for initiation of Phase I clinical trials; Developing prototype devices to Investigational Device Exemption (IDE) stage for initiation of clinical trials; Optimizing diagnostic or treatment devices for field deploymentTo meet the intent of the FY15 JPC-8/CRMRP ERTTDA, applicants must specifically address one or both of the Focus Areas listed below; (1) Treatments of soft tissue injury, specifically, nerve, muscle, and vascular injury to the extremities. The aim of these technologies is to: (a) maintain the structure and function of denervated end organs distal to a nerve injury; (b) restore functional muscle tissue; and (c) restore vascular perfusion. Both innovative definitive care solutions as well as innovative technologies that may better enable a definitive care solution to be delivered at some future time point, such as vascular shunting or stenting technologies, will be considered; (2) Treatments for bone healing, for example, technologies that create a wound environment more conducive to bone healing following injury to the extremities.

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