Massachusetts General Hospital
Curtis L. Cetrulo, MD
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.
Facial Trauma
Facial Deformity
Facial Injuries
Face allotransplantation
Not Applicable
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 |
Estimated Enrollment : | 4 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Face Transplantation |
Actual Study Start Date : | March 2023 |
Estimated Primary Completion Date : | December 2027 |
Estimated Study Completion Date : | December 2030 |
Arm | Intervention/treatment |
---|---|
Experimental: Face Transplant Recipient The procedure will be carried out simultaneously by two teams of transplant surgeons for each face transplanted in the operation. The teams will be divided between the functions of tissue recovery (donor operation) and transplant surgery (recipient operation). In most cases the facial graft will include the entire nose; the soft tissues of the mid-face, including all its blood vessels, muscles, and nerves; and a significant portion of the mid-facial skeleton. |
Procedure: Face allotransplantation |
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.