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Face Transplant for Functional Recovery

Not yet recruiting at 8 trial locations
OA
Overseen ByOmowunmi Afolabi, MSc. Psychology
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

VG

Vijay Gorantla, MD, PhD, FRCS

Principal Investigator

Wake Forest University Health Sciences

BP

Bohdan Pomahac, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with severe facial injuries or defects who may benefit from a face transplant. Participants must be healthy enough for major surgery and long-term medication, and cannot have conditions that would make the procedure unsafe.

Inclusion Criteria

I am motivated for a face transplant and understand its risks, benefits, and commitments.
Participants must show evidence of psychological stability and adaptive coping with stable treatment for conditions like depression, anxiety, or PTSD when documented and managed
I do not have any active cancer.
See 23 more

Exclusion Criteria

Documented pattern of poor adherence or inability to engage with follow-up despite trauma-informed efforts to reduce barriers
My donor has had head or neck radiation that affected tissue health.
Any condition or circumstance judged by transplant team and IRB to pose unacceptable risk or compromise ethical conduct
See 23 more

What Are the Treatments Tested in This Trial?

Interventions

  • Facial Vascularized Composite Allotransplantation

Trial Overview

The study tests face transplantation (facial VCA) to see how well the transplanted tissue survives over five years, as well as improvements in function and quality of life after surgery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Facial Vascularized Composite AllotransplantationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Wake Forest University Health Sciences

Collaborator

Trials
1,432
Recruited
2,506,000+

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