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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Yale University
Study ID
NCT07810764
Status
Not Yet Recruiting

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Conditions

  • Facial Vascularized Composite Allotransplantation
  • Functional Recovery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 9, 2026
Start date
Oct 31, 2027
Status verified
Sep 2026
Primary completion
Oct 31, 2037
Completion
Oct 31, 2037

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Facial Vascularized Composite Allotransplantation
    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.

Primary Outcome Measure

Number of participants with Allograft Survival at 60 months [ Time Frame: Day 0 (surgery), weekly during initial hospitalization, months 1, 3, 6, 12, 18, 24, and annually thereafter through Month 60 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Yale New Haven Hospital / Yale UniversityNew HavenConnecticut06519-
University of LouisvilleLouisvilleKentucky40292-
Johns Hopkins MedicineBaltimoreMaryland21205-
Brigham and Women's HospitalBostonMassachusetts02115-
Mayo ClinicRochesterMinnesota55902-
NYU Langone HealthNew YorkNew York10016-
Cleveland ClinicClevelandOhio44195-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAYale New Haven Hospital / Yale University· New Haven, CTUniversity of Louisville· Louisville, KYJohns Hopkins Medicine· Baltimore, MDBrigham and Women's Hospital· Boston, MAMayo Clinic· Rochester, MN

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