30
Participants
Start Date
July 21, 2011
Primary Completion Date
June 30, 2036
Study Completion Date
June 30, 2036
Deceased donor hand transplantation
Deceased donor hand is surgically attached to recipient arm's stump.
Bone marrow cell-based therapy & single-drug immunosuppression.
This protocol uses a novel bone marrow cell-based therapy for composite tissue allotransplantation (CTA) rather than conventional triple-drug immunosuppression to facilitate long-term graft survival of deceased donor human upper extremities under low-dose maintenance immunosuppression. Initial T-cell depletion with alemtuzumab is followed by upper extremity transplantation and tacrolimus maintenance therapy. Donor bone marrow cells are infused on Day 10 (±4 days) post-transplantation to elicit a host alloimmune response triggering exhaustion and deletion of the respective host (anti-donor) lymphocyte clones. Subsequently, tacrolimus therapy is given for at least 6 months before spaced weaning is considered in stable recipients.
RECRUITING
Johns Hopkins University School of Medicine, Baltimore
Johns Hopkins University
OTHER