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

NCT07810790 | Not Yet Recruiting

• 2 other identifiers: 2000042327HT9425-23-3-0001
• 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 upper extremity vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol.

Conditions

Functional Recovery; Upper Extremity Vascularized Composite Allotransplantation

Keywords

Composite tissue allotransplantation; Rehabilitation; Vascularized composite allotransplantation; Upper-extremity transplantation; Hand transplantation

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 upper extremity 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 (20)

• Mean Active Range of Motion

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

• Muscle strength assessed using Clinical Motor Grading (MRC Scale)

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

• Mean Grip Strength

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

• Mean Pinch Strength

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

• Carroll Upper Extremity Function Test (UEFT)

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

Study Arms (1)

Upper Extremity Composite Allotransplantation

EXPERIMENTAL

Upper Extremity 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: Upper Extremity Vascularized Composite Allotransplantation (VCA)

Interventions

Upper Extremity Vascularized Composite Allotransplantation (VCA) PROCEDURE

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

Upper Extremity 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.
• where feasible, to support psychosocial and aesthetic integration.
• Willingness to undergo comprehensive psychosocial evaluation and ongoing monitoring by the multidisciplinary team.
• Demonstrated motivation for transplantation and understanding of the investigational nature of upper extremity 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 upper extremity disfigurement involving amputation proximal to the wrist.
• Conventional restorative options, including advanced myoelectric or body-powered prostheses, must be documented as exhausted (defined as a minimum of 12 months of consistent use of myoelectric or body-powered prostheses with a QuickDASH score remaining above 30), infeasible (due to stump length or soft tissue coverage), or clinically inadequate for restoring the sensory-motor integration required for the participant's essential functional needs.
• Identified plan for access to immunosuppressive medications and required follow up care (e.g., insurance coverage, assistance programs, institutional support), coordinated with social work and financial counseling.
• Willingness and ability, with available supports, to attend required follow up visits (in person or via approved telehealth where appropriate).
• Donor:
• Legal declaration of brain death

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 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)