Principal Investigator: Ji Hyun Kim, PhD
Organization: Wake Forest Institute for Regenerative Medicine
Pelvic and urogenital injuries account for 86% of urologic injuries in US armed conflicts, impacting the medical and combat readiness of wounded soldiers. Current surgical repair attempts often fail in restoring normal pelvic muscle anatomy. While autologous cell-based treatment shows promise in improving muscle function, its applicability in combat situations may be hindered by complex manufacturing processes. To address this issue, we propose an innovative and practical off-the-shelf muscle construct platform using functionalized acellular muscle fiber fragments capable of rapidly assembling into volume-stable muscle fibers that integrate into the host to restore normal muscle mass and function. This cell-free product can be stably stored for point-of-care use, providing a convenient solution closer to the point of need. Utilizing three-dimensional (3D) biofabrication technology, the manufacturing platform allows for personalized muscle implants tailored to each patient’s specific defect. In this project, we will 1) determine the optimal bioprinting process parameters of the implantable fragment manufacturing platform, 2) determine the therapeutic effectiveness andvalidate the clinical feasibility of using the platform prototype for restoring pelvic floor muscle volume and function, and 3) develop the manufacturing process and regulatory strategy.