Clinical Trial: Craniomaxillofacial Allotransplantation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Craniomaxillofacial Allotransplantation
Brief Summary: The purpose of this study is to perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and evaluate the acceptance and function of the transplanted tissue. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.
Detailed Summary:
This study is to perform facial transplants in patients with severe facial deformities or facial wounds from traumatic injuries. The transplant is to help reconstruct a person's damaged face. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.
There are some procedures in plastic and reconstructive surgery that can repair the look of a patient's face, but often can't replace the movement and use of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. Conventional reconstruction method requires multiple surgeries in order to form and shape the transplanted tissue. Because this type of reconstruction is limited, it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face.
This study uses a composite tissue allograft , or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants. The damaged parts of the face could return movement as well. Transplanted patients are required to take lifelong immunosuppression drugs which have risks, which are still a consideration when deciding to choose this option for correcting severe facial deformities.
We will conduct the surgery and prospectively follow the patient to monitor signs of rejection of the transplanted face. Additionally, patients will be constantly evaluated for clinical and functional outcomes and ensure that optimal results are achieved.
Sponsor: New York University School of Medicine
Current Primary Outcome: Evaluate the success of the face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5 ]
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment.
These will be measured using various multi-disciplinary evaluations including swallow studies, photography, speech therapy evaluation, Occupational therapy evaluation, electromyogram (EMG) , Nerve Conduction Study (NCS), CT Angiogram, Functional ( Magnetic Resononance Image) MRI, vision exams, pathology samples to check for rejection, Blood tests
Original Primary Outcome: Evaluate the success of the face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5 ]
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment.
These will be measured using various multi-disiplinary evaluations including swallow studies, photography, speech therapy evaluation, Occupational therapy evaluation, EMG, NCS, CT Angiogram, Functional MRI, vision exams, pathology samples to check for rejection, Blood tests
Current Secondary Outcome: Evaluate psychological effects of receiving a face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually until year 5 ]
Original Secondary Outcome: Same as current
Information By: New York University School of Medicine
Dates:
Date Received: June 5, 2014
Date Started: June 2014
Date Completion: June 2020
Last Updated: August 17, 2016
Last Verified: August 2016
