Human Craniomaxillofacial Allotransplantation

PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2031

Conditions
Facial InjuriesTraumatic Wounds and InjuriesCraniofacial InjuriesCraniofacial DefectsFacial TransplantationFacial Deformity
Interventions
DRUG

Bone marrow cell-based therapy & 1-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 faces 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.

Trial Locations (1)

21287

RECRUITING

Johns Hopkins University School of Medicine, Baltimore

All Listed Sponsors
lead

Johns Hopkins University

OTHER