Clinical Trial: Human Craniomaxillofacial Allotransplantation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Human Craniomaxillofacial Allotransplantation

Brief Summary:

Background: The human face is critically important for breathing, eating, seeing, and speaking/ communicating, but its most important job may be to look like a human face. Devastating facial deformities often cause affected individuals to avoid human contact and disappear from society. Although current surgical advancements can somewhat restore facial defects, this process often requires many operations and the resulting face only resembles the human face. To date, over 20 face transplants have been performed with highly encouraging functional and aesthetic results, but widespread clinical use has been limited due to the adverse effects of life-long and high-dose immunosuppression needed to prevent graft rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly affect recipients' quality of life, make the procedure riskier, and jeopardize the potential benefits of face transplantation.

Study Design: This non-randomized, Phase II clinical trial will document the use of a new immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face transplantation as a safe and effective reconstructive treatment for devastating injuries/ defects by minimizing maintenance immunosuppression therapy in face transplant patients. This protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled graft survival using low doses of a single immunosuppressive drug followed by weaning of treatment. Initially designed for living-related solid organ donation, this regimen has been adapted for use with grafts donated by deceased donors. The investigators propose to perform 15 full or partial human face transplants employing this novel protocol.

Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the trea

Detailed Summary:
Sponsor: Johns Hopkins University

Current Primary Outcome: Graft Survival [ Time Frame: Transplantation through end of study period (up to 5 years) ]

Post-operative graft survival will be documented monthly Months 1-12 and quarterly (every 3 months) Years 2-5.


Original Primary Outcome: Same as current

Current Secondary Outcome: Documentation of immunosuppression required by transplanted participants to maintain graft. [ Time Frame: Transplantation to end of study period (up to 5 years) ]

Post-operative serum trough levels will be documented daily Days 1-28, semiweekly Weeks 5-12, weekly Weeks 13-25, biweekly Weeks 26-38, monthly Months 10-12, and quarterly (every 3 months) Years 2-5.


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: June 26, 2013
Date Started: August 2012
Date Completion: August 2026
Last Updated: March 8, 2016
Last Verified: March 2016