Principal Investigator: James J. Yoo, MD, PhD
Organization: Wake Forest Institute for Regenerative Medicine
Rotator cuff injuries or tears have a significant impact on both civilian and military populations, affecting approximately 17 million individuals in the United States alone. Military personnel experience even higher rates of these injuries, 20 times more than the general population. Rotator cuff injuries result in severe pain, limited mobility, muscle weakness, and early fatigue, greatly hindering daily activities and military duties. Although surgical repair is possible, surgical interventions often fall short of fully restoring muscle function, leading to re-rear rates ranging from 13% to 90%. Currently, there is no universally accepted surgical “gold standard” for restoring rotator cuff/shoulder strength and function. Regenerative medicine-based therapies, such as cell-based and cell-free approaches, offer potential alternatives, demonstrating promising results in animal studies. However, the challenge lies in effectively regenerating stable and functional clinically significant muscle tissues. In addition, the cell-based approaches may not be applicable in combat situations due to the lengthy and complex processing steps. To address this clinical issue, we propose an injection therapy platform using decellularized muscle fiber fragments for immediate use in a military theater to improve muscle mass and function in the upper extremity of patients with shoulder rotator cuff injury. The cell-free and lyophilized decellularized muscle fiber fragments can remain stable at ambient temperatures and allows the end-user (e.g., physician) to inject immediately in the target sites of wounded worriers following reconstitution in physiological solutions (e.g., normal saline) in combat situations. In this project, we will 1) determine the optimal bioengineering process of the decellularized muscle fiber fragment injection platform, 2) determine the therapeutic effectiveness and validate the clinical feasibility of using the platform prototype for restoring rotator cuff muscle volume and function, and 3) develop the manufacturing process and regulatory strategy.