Study of Hand Transplantation Using Belatacept to Improve Daily Function for Adults with Limb Loss

What this Trial Is About

Researchers are evaluating the safety and effectiveness of hand transplantation as a treatment for people who have lost a limb below the elbow. This Phase 2 study focuses on whether patients can use the transplanted hand in everyday activities 18 months after the procedure. The study also tests a new immunosuppressant drug called Belatacept, which is already approved for kidney transplants but is investigational here for preventing rejection in hand transplants. Participants will receive a hand transplant from a deceased donor and be treated with Belatacept to help prevent rejection. The study involves multiple visits over 18 months for assessments, including medical history, vital signs, psychosocial evaluations, urine and blood tests, chest X-rays, bone density scans, and biopsies. The research team collects detailed data on recipient and donor information, transplant history, range of motion, sensation, and immunosuppressive medications. During the study, participants will be closely monitored for their ability to use the transplanted limb and signs of rejection through clinical and tissue evaluations. Researchers will use a quantitative functional test at 18 months to measure daily living activity use. Safety assessments include monitoring for infection, rejection, and risks related to procedures like blood draws and biopsies. All personal data are securely handled according to strict privacy standards, with participation lasting 18 months.

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy