Human Composite Facial Allotransplantation

Methodist Health System

Status

Completed

Conditions

Transplantation: Facial Transplantation

Treatments

Procedure: Facial Allotransplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT05117190

028.TRN.2014.D

Details and patient eligibility

About

Allotransplantation of maxillofacial of subject with severe facial deformities due to traumatic events.

Full description

A facial transplantation is a highly dynamic, prolonged operation requiring teams communicating seamlessly through its duration. This is similar to complex solid organ transplant teams at Methodist Transplant Institute. The Institute's clinical experience in management of complex facial defects and deformities along with the personnel and infrastructure at Methodist Dallas transplant institute would help develop a center for Facial Allotransplantation. The team experience, true collaboration, creativity and a unique approach to each patient would help provide the optimal care and reconstruction for the face allotransplant patient both before and after surgery.

The purpose of this study is centered on the advancement of a safe and effective procedure for Facial Allotransplantation at Methodist Hospital Medical Center at Dallas. Composite tissue allotransplantation for facial reconstruction is in its infancy as liver transplantation was 30 years ago when the first liver transplant was completed in Texas. This study will establish Methodist Hospital System as a center for Facial Allotransplantation for reconstruction of extensive facial defects resulting in functional loss and poor quality of life.

Patient participation post transplantation will either be for life, or failure of the composite tissue allograft. Patient enrollment will be initiated immediately after the IRB approval. The enrollment period will be completed after the patient receives the final transplant, and the study will be completed at 24 months after the final transplant. However, all patients enrolled into the study will have lifelong follow up with immunosuppressive management, psychological support, and evaluation of functional recovery per protocol.

Enrollment

3 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Between ages 18-70 years
Must be willing to undergo major facial reconstruction
Be able to understand the pre and post-transplantation evaluation, physical therapy, and follow up procedures
Conventional reconstruction deemed unsatisfactory

Exclusion criteria

Medically unable to provide consent
Active infections such as Human Immunodeficiency Virus, mycobacteria, hepatitis B, and hepatitis C
Recent history of alcohol or IV drug or chemical dependency
Psychiatric evaluation that indicate mental instability or non-compliance
Cognitively impaired and Terminally ill
Women of child bearing age with intent to conceive, pregnant or lactating
Unable to receive immunosuppression after transplantation because of either geographic or financial limitations
End stage organ disease (renal failure, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), etc.)
Chronic infections such as osteomyelitis