Face Transplantation

NCT05699187 | Withdrawn

• 1 other identifier: 2021P002531
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Facial Trauma; Facial Deformity; Facial Injuries

Keywords

Transplant; Face Transplant

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Incidence of rejection episodes on triple therapy immunosuppression

  1 Year

Study Arms (1)

Face Transplant Recipient

EXPERIMENTAL

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

Interventions

Face allotransplantation PROCEDURE

Facial allotransplantation

Face Transplant Recipient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Facial Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Curt Cetrulo, MD, FACS, FAAP

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Curtis L. Cetrulo, Jr., M.D., FACS, FAAP

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share