Phase II Study of Face Transplantation Using a New Bone Marrow Cell Therapy and Reduced Single-Drug Immunosuppression to Treat Severe Facial Injuries

What this Trial Is About

Researchers are studying a new immunomodulatory protocol called the Pittsburgh Protocol for face transplantation in individuals with severe facial injuries or defects. This Phase II clinical trial aims to make face transplantation safer and more effective by reducing the need for lifelong, high-dose immunosuppression, which currently carries risks like infection, cancer, and metabolic problems. The goal is to improve graft survival while minimizing these risks, helping patients regain facial function and social integration. The study involves performing 15 full or partial face transplants using a novel treatment approach that combines lymphocyte depletion with donor bone marrow cell infusion. After transplantation, participants receive low-dose maintenance immunosuppression with a single drug, tacrolimus, beginning with T-cell depletion via alemtuzumab. Donor bone marrow cells are infused about 10 days after transplantation to promote immune tolerance. Tacrolimus is maintained for at least six months before considering gradual reduction. Participants will be closely monitored throughout the study, which may last up to five years, to assess graft survival and the amount of immunosuppression needed. Evaluations include clinical assessments, documentation of immunosuppression levels, and safety monitoring. The study focuses on maintaining graft function while reducing long-term drug exposure. Overall participation spans from transplantation through the end of the study period, with ongoing follow-up to track outcomes and potential complications.

Human Craniomaxillofacial Allotransplantation