Facial Vascularized Composite Allotransplantation: A Study Evaluating Safety, Functional Outcomes, and Patient-Reported Psychosocial Outcomes

NCT07810764 | Not Yet Recruiting

• 2 other identifiers: 2000042326HT9425-23-3-0001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 9

Brief Summary

The primary objective of this study is to evaluate the 5-year (60-month) allograft survival rate of facial vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol.

Conditions

Facial Vascularized Composite Allotransplantation; Functional Recovery

Keywords

Vascularized composite allotransplantation; Face transplantation; Composite tissue allotransplantation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number of participants with Allograft Survival at 60 months

  Allograft survival is defined as the continued presence of the transplanted facial tissue with evidence of adequate vascular perfusion assessed as clinical evaluation by the surgical team. Survival is a binary categorical variable (Success/Failure). Failure is defined as total graft loss necessitating surgical removal (explantation).

  Day 0 (surgery), weekly during initial hospitalization, months 1, 3, 6, 12, 18, 24, and annually thereafter through Month 60

Secondary Outcomes (13)

• Number of participants with Motor Function Change

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

• Number of participants with Sensory Restoration

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

• Mean score General Health Status (PROMIS-29 v2.0)

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

• Mean score Health Utility (EQ-5D-5L)

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

• Mean score Face-Specific PROMs (FACE-Q)

  Baseline, 3, 6, 12, 24, 36, 48 and 60 months

Study Arms (1)

Facial Vascularized Composite Allotransplantation

EXPERIMENTAL

Facial VCA performed under a standardized CONSORT clinical protocol. The study utilizes a longitudinal cohort design where each participant serves as their own control pre and post transplant.

Procedure: Facial Vascularized Composite Allotransplantation (VCA)

Interventions

Facial Vascularized Composite Allotransplantation (VCA) PROCEDURE

Facial VCA, performed to treat severe facial defects. This procedure will be performed by qualified surgeons in accordance with standard institutional surgical practices.

Facial Vascularized Composite Allotransplantation

Eligibility Criteria

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

You may qualify if:

• Participants:
• Competent to provide informed consent, as determined through structured clinical assessment by qualified study personnel, and able to demonstrate adequate psychosocial support, including caregiver or other support-person assistance as needed, to facilitate postoperative recovery, adherence to immunosuppressive therapy, and long-term study follow-up.
• Non smoker at the time of transplantation (no cigarettes, vaping, or nicotine products), with counseling and support offered for cessation as needed.
• For participants of reproductive potential:
• Negative pregnancy test at listing and again immediately prior to transplant.
• Agreement to use effective contraception throughout study participation and for at least 12 months post transplant.
• A serum pregnancy test performed shortly before transplantation will be determinative; individuals who are pregnant at that time will be screen failures for the transplant intervention, though may be offered continued follow up and support as appropriate.
• Willingness to undergo comprehensive psychosocial evaluation and ongoing monitoring by the multidisciplinary team.
• Demonstrated motivation for transplantation and understanding of the investigational nature of facial VCA, including its risks, potential benefits, alternatives, and long-term commitments.
• Evidence of psychological stability and adaptive coping, with attention to prior trauma, grief, and body-image disturbances; stable treatment for conditions such as depression, anxiety, or post-traumatic stress disorder is acceptable when documented and appropriately managed.
• Demonstrated capacity for adherence and, when available, a history of adherence to complex medical regimens, such as chronic disease treatment, dialysis, or transplant care, recognizing that prior barriers may be mitigated through structured supports and longitudinal follow-up.
• Availability of adequate family, caregiver, and/or social support, including an identified caregiver, support person, or formal support services, sufficient to assist with postoperative recovery, medication adherence, transportation, and psychosocial needs. A caregiver/family information sheet will be provided to support persons to promote realistic expectations prior to consent.
• Final psychosocial approval by a transplant mental health professional in consultation with the broader psychosocial team.
• Severe facial disfigurement involving one or more central facial structures or functional subunits (e.g., perioral, periorbital, nasal, midface) with major impact on function and appearance.
• Disfigurement must result in substantial functional impairment (e.g., speech, mastication, swallowing, breathing, eyelid closure, eye protection) and/or psychosocial burden (e.g., profound body image disturbance, social withdrawal, stigma) such that conventional reconstructive options are exhausted, infeasible, or reasonably expected to be inadequate for restoring function or appearance.

You may not qualify if:

• Anatomical or surgical factors that render transplantation unsafe or technically unfeasible (e.g., prohibitive vascular disease, prior surgeries precluding adequate anastomoses) in the judgment of the surgical team.
• Active or inadequately treated serious infection, including tuberculosis, hepatitis B or C with uncontrolled viremia, or syphilis.
• Active malignancy.
• History of melanoma or other high risk, virus driven malignancies.
• Malignancy in remission \<5 years, except for selected low risk, non viral cancers explicitly reviewed and approved by the transplant team.
• Must have clearance for transplant from oncology.
• Decompensated liver disease without hepatology clearance
• Decompensated or advanced cirrhosis
• Uncontrolled or uncorrectable comorbidities that substantially elevate perioperative or immunosuppressive risk despite optimization efforts (e.g., uncontrolled diabetes with end organ damage, uncontrolled hypertension, uncorrected coagulopathy).
• Current pregnancy or stated intent to become pregnant within 12 months of transplant.
• Inability or unwillingness to use effective contraception, when applicable.
• Documented pattern of poor adherence or inability to engage with follow up despite reasonable, trauma informed efforts to reduce barriers (e.g., transportation, scheduling, health literacy, financial support).
• Active psychiatric illness that currently impairs judgment, decisional capacity, or capacity to adhere to care (e.g., untreated psychosis, severe untreated depression with suicidality, impaired reality testing), as determined by the transplant psychosocial team.
• Smoking at the time of transplantation (including cigarettes, vaping, or nicotine products)
• Active substance use disorder (alcohol or drugs) without sustained remission and without adequate recovery supports, unless the multidisciplinary team determines that risk has been sufficiently mitigated.

Sponsors & Collaborators

• Yale University: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (9)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Yale New Haven Hospital / Yale University

New Haven, Connecticut, 06519, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21205, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Bohdan Pomahac, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Vijay Gorantla, MD, PhD, FRCS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omowunmi Afolabi, MSc. Psychology

CONTACT

203-737-4752; omowunmi.afolabi@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of five procedures will be performed. Given the five-procedure cap, enrollment opportunities will be limited and dependent upon donor availability, candidate eligibility, multidisciplinary review, and regulatory readiness across participating sites.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): October 1, 2027
• Primary Completion (Estimated): October 1, 2037
• Study Completion (Estimated): October 1, 2037
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)