Face Transplantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Facial Injuries; Facial Deformity; Facial Trauma
• Intervention / Treatment: Procedure: Face allotransplantation

Detailed Description

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
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Curt Cetrulo, MD, FACS, FAAP; Phone Number: 877-424-5678; Email: CCETRULO@mgh.harvard.edu
• Study Contact Backup: Name: Curt Cetrulo, MD, FACS, FAAP; Email: CCETRULO@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Recent (≥6 months) or remote (i.e., several decades) severe facial disfigurement and/or facial functional impairment covering at least 25% of face and/or a major part e.g. nose, lips and desiring face transplantation.
• Aged 18-65 years. Noted should be that the maximal age difference between donor and recipient will be 10 years.
• Completion of the protocol informed consent form.
• No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (see Donor and Recipient Exclusion Criteria below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of facial transplantation.)
• No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
• Negative for malignancy for past 5 years.
• Negative for HIV at transplant.
• Negative crossmatch with donor.
• If female of child-bearing potential, negative serum pregnancy test. If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.
• Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.
• No smoking for 6 months prior to transplant, as confirmed by blood testing.

Exclusion Criteria:

• Positive for any of the following conditions: Untreated sepsis, HIV (active or seropositive), active tuberculosis, hepatitis B or C (HCV Ab+ and HCV RNA+ (HCV Ab+ but RNA negative is acceptable), HBVcAb+, HBVsAg+ or viral DNA+), viral encephalitis, toxoplasmosis, malignancy (within past 5 years), current/recent (within months of donation/consent) IV drug abuse, paralysis of ischemic or traumatic origin, inherited peripheral neuropathy, infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy, toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure), mixed connective tissue disease, severe deforming rheumatoid or osteoarthritis in the limb.
• Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment, including all liver and renal disease.
• Sensitized recipients with high levels (>=50%) of panel-reactive HLA antibodies.
• Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.
• Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.
• Conditions that may impact functional outcomes including lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.
• Pregnant, breastfeeding or planning to become pregnant within the next 2 years.
• Unable or unwilling to use an acceptable birth control method for 2 years following transplant. The patient cannot have given birth in the past 2 years. We acknowledge that a female recipient of childbearing age must carefully consider the associated risks of the transplant and immunosuppression and personally prioritize these issues and the lead face transplant surgeon (Dr. Cetrulo) will implement this subject in the preoperative education of the patient during consultation.
• Patients will be required to stop smoking for 6 months prior to listing and abstain from postoperative smoking
• If a subject does not receive a transplant after one year of enrollment, clinical consent will be re-obtained from that subject and clinical consent will be re-obtained yearly while the subject is enrolled and waiting for a donor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; Facial allotransplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of motor function of face	Function of face as assessed by ability to move face, smile, frown, etc.	1 Year
Incidence of intact sensation of face	Sensation of face intact using standard methods (sharp vs dull, presence of numbness)	1 Year
Incidence of an ascetically satisfactory appearing face	Evaluated by overall appearance, symmetry	1 Year
Incidence of a cost benefit to facial transplant	This will be assessed by standard treatment of facial disfigured patients vs face transplant	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of rejection episodes on triple therapy immunosuppression	1 Year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Curt Cetrulo, MD, FACS, FAAP, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2030

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Transplant; Face Transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Craniocerebral Trauma; Trauma, Nervous System; Facies; Facial Injuries
• Other Study ID Numbers: 2021P002531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No