Clinical Trial: Face Transplantation Clinical Trial

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

Official Title: Protocol for Composite Facial Allograft Transplant

Brief Summary: The purpose of this study is to apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome.

Detailed Summary: The human scalp and face define two important body units, both functionally and aesthetically. Traumatic deformities of the head and neck region resulting from burn injuries, gun shot wounds, or ablative tumor surgeries may involve the defect of the skin, subcutaneous tissue, muscle or the combination of all these elements. In most cases, the ideal reconstruction is very difficult to achieve. Sometimes, a major part of face along with the ear or the nose may be involved. The extensive scalp loss due to burn or avulsion injury is another deforming and psychologically debilitating condition presenting as a major reconstructive challenge. An ideal reconstructive procedure should replace the missing tissues and restore the motor and sensory function. Traditional reconstructive procedures of facial deformities involve skin grafting, local flap applications, tissue expansion, and prefabrication as well as free tissue transfers. The primary goal during facial reconstruction is restoration of the function and aesthetic appearance. To obtain satisfactory results, missing parts should be replaced only by tissues of the same color and texture. The purpose of this study is to apply human facial allograft transplant to the subjects with severe facial deformities or disfigurements in order to provide adequate coverage, aesthetic appearance and functional outcome.
Sponsor: The Cleveland Clinic

Current Primary Outcome: Evaluate the success of the face transplant [ Time Frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years. ]

Demonstrate stable engraftment and restoration of facial skin/bone coverage and sensory-motor function in recipients of composite tissue allografts of vascularized skin, bone, and soft tissue augments(nose, ear, lips, eyelids, etc)under standard immunopression protocol.


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate tolerogenic properties of the immunosuppression protocol [ Time Frame: Patients will be carefully screened and monitored post-operatively for signs of rejection or flap failure for 5 years. ]

Characterize tolerogenic properties of our immunosuppression protocol, by monitoring of donor specific chimerism and presence of T regulatory cells in the face allograft transplant recipients.


Original Secondary Outcome: Same as current

Information By: The Cleveland Clinic

Dates:
Date Received: December 30, 2010
Date Started: July 2010
Date Completion: December 2022
Last Updated: November 16, 2016
Last Verified: November 2016