Friday, September 21, 2012

Clinical Trial Involving Limb Muscle Repair, Seeking Participants

Traumatic Limb Muscle Loss Clinical Trials, please contact Allyson LaCovey at 412-624-5308 or lacoveya2@upmc.edu. More information about the trial can be found on this study recuitment flyer, at the trial website, or Dr. Badylak's laboratory website. Trial Website: Traumatic Limb Muscle Loss Clinical Trials "Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) with the Use of Biologic Scaffolds for Patients Suffering From Severe Skeletal Muscle Injury We are conducting a research study to help us improve the surgical treatment of people who have suffered a severe loss of muscle and/or tendon tissue as a result of an injury to their arms or legs. You will undergo a standard reconstructive surgical procedure that is performed at UPMC hospitals to repair muscle and tendon tissue. During this surgical procedure, you also will receive an extracellular matrix (ECM), a material that functions outside of the body's cells to lay a framework to provide structural support for cells to grow on. This matrix has been developed to strengthen and reinforce the surgically repaired muscle tendons, and it provides a structural framework to support the growth of new tissue and blood vessels in that area. The ECM has been approved by the Food and Drug Administration as an "implantable device." It is made from cow tissue and composed mostly of collagen (a naturally occurring protein in our bodies). In this study, an FDA-approved ECM device will be used during the surgical repair procedure. The operative procedure for this study is considered a research procedure. The goal of this research study is to observe how each person’s injuries heal over time, and to measure changes in the functional ability of the repaired limb during a six-month, postsurgical follow-up period. We plan to enroll in the study approximately 40 adults, male or female, civilian or military personnel, 18 to 60 years of age."