Hand and Arm Transplantation Using a New Immunotherapy Protocol for Adults With Upper Limb Amputations

What this Trial Is About

Millions of people experience upper limb loss due to injuries, surgeries, or birth defects, and traditional prostheses often provide limited motor function and no sensation. Researchers are evaluating a new immunomodulatory protocol, called the Pittsburgh Protocol, in a Phase II clinical trial to make hand transplantation safer and more effective by reducing the need for lifelong high-dose immunosuppression, which can cause serious side effects like infections and cancer. This study aims to improve the quality of life for individuals with upper extremity amputations by enabling better graft survival with fewer risks. The trial involves performing up to 30 hand or forearm transplants using a novel approach that combines lymphocyte depletion, donor bone marrow cell infusion, and low-dose single-drug immunosuppression tacrolimus. After transplantation, donor bone marrow cells are infused about 10 days later to help the recipients immune system accept the graft. Tacrolimus is given for at least six months and then gradually reduced if the transplant remains stable. This protocol was adapted from treatments originally designed for organ donation and aims to minimize the side effects of traditional multi-drug immunosuppression. Participants will undergo thorough screening and follow-up evaluations over up to five years, during which researchers will monitor graft survival and the level of immunosuppressive drugs required to maintain it. Assessments include medical exams, blood tests, and continuous observation of immune response and transplant function. The study also tracks safety outcomes and functional results to better understand how well this protocol supports long-term hand transplant success and patient well-being.

Human Upper Extremity Allotransplantation