Clinical trial NCT05117190: Human Composite Facial Allotransplantation
Official title: Human Composite Facial Allotransplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplantation: Facial Transplantation
Keywords: Facial Transplantation
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Facial Clinimetric Evaluation Scale
timeFrame: measured at 6 weeks
measure: Modified Facial Clinimetric Evaluation Scale
timeFrame: measured at 3 months
measure: Modified Facial Clinimetric Evaluation Scale
timeFrame: measured at 6 months
measure: Modified Facial Clinimetric Evaluation Scale
timeFrame: measured at 12 months
measure: Modified Facial Clinimetric Evaluation Scale
timeFrame: measured at 18 months
measure: Modified Facial Clinimetric Evaluation Scale
timeFrame: measured at 24 months
measure: Facial Disability Index
timeFrame: measured at 6 weeks
measure: Facial Disability Index
timeFrame: measured at 3 months
measure: Facial Disability Index
timeFrame: measured at 6 months
measure: Facial Disability Index
timeFrame: measured at 12 months
measure: Facial Disability Index
timeFrame: measured at 18 months
measure: Facial Disability Index
timeFrame: measured at 24 months
measure: SF-36 Health Survey
timeFrame: measured at 6 weeks
measure: SF-36 Health Survey
timeFrame: measured at 3 months
measure: SF-36 Health Survey
timeFrame: measured at 6 months
measure: SF-36 Health Survey
timeFrame: measured at 12 months
measure: SF-36 Health Survey
timeFrame: measured at 18 months
measure: SF-36 Health Survey
timeFrame: measured at 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: Methodist Health System
name: Likith V. Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: