Face allotransplantation will be performed in facial trauma patients. Immune suppression will primarily be provided according to standard three-drug regimen. The primary outcome to be evaluated in the proposed trial is face allograft acceptance.
Patients with severe facial disfigurement referred or self-identified to the MGH Face Transplantation Program will undergo a consultation with the PI (Dr. Cetrulo) who will perform a thorough clinical assessment and explain in detail the treatment protocol, risks and benefits of the face allotransplantation procedure and alternative options. At the time of appointment, candidates will be first requested to sign a face transplant Research Informed Consent form . Following the signing of these documents, the candidate will meet with the MGH Transplant Center team (see below for description of entire team), a clinical pharmacist, dietician, and a transplant social worker. Appropriate subjects will then undergo further evaluation/medical screening procedures to determine their candidacy for face transplantation. Prospective recipients who are selected based on results of screening procedures will be invited to review and sign the full informed consent form prior to being wait-listed for the procedure. There is a significant evaluation using tests, procedures, consults, and evaluations that will be performed as part of the standard of care for those clinically-approved for organ transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Facial allotransplantation
Incidence of motor function of face
Function of face as assessed by ability to move face, smile, frown, etc.
Time frame: 1 Year
Incidence of intact sensation of face
Sensation of face intact using standard methods (sharp vs dull, presence of numbness)
Time frame: 1 Year
Incidence of an ascetically satisfactory appearing face
Evaluated by overall appearance, symmetry
Time frame: 1 Year
Incidence of a cost benefit to facial transplant
This will be assessed by standard treatment of facial disfigured patients vs face transplant
Time frame: 1 Year
Incidence of rejection episodes on triple therapy immunosuppression
Time frame: 1 Year
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