Human Composite Facial Allotransplantation

Study Overview
=================
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.

Official Title
-----------------
Human Composite Facial Allotransplantation

Conditions
-----------------
Transplantation: Facial Transplantation

Intervention / Treatment
-----------------
* Procedure: Facial Allotransplantation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Facial Deformity<br>Face not the normal shape because of injury or illness. | Procedure: Facial Allotransplantation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Facial Clinimetric Evaluation Scale | validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis. | measured at 6 weeks | 
| Modified Facial Clinimetric Evaluation Scale | validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis. | measured at 3 months | 
| Modified Facial Clinimetric Evaluation Scale | validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis. | measured at 6 months | 
| Modified Facial Clinimetric Evaluation Scale | validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis. | measured at 12 months | 
| Modified Facial Clinimetric Evaluation Scale | validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis. | measured at 18 months | 
| Modified Facial Clinimetric Evaluation Scale | validated quality-of-life instrument that is used to assess facial impairment and disability after facial paralysis. | measured at 24 months | 
| Facial Disability Index | a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders | measured at 6 weeks | 
| Facial Disability Index | a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders | measured at 3 months | 
| Facial Disability Index | a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders | measured at 6 months | 
| Facial Disability Index | a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders | measured at 12 months | 
| Facial Disability Index | a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders | measured at 18 months | 
| Facial Disability Index | a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders | measured at 24 months | 
| SF-36 Health Survey | a set of generic, coherent, and easily administered quality-of-life measures | measured at 6 weeks | 
| SF-36 Health Survey | a set of generic, coherent, and easily administered quality-of-life measures | measured at 3 months | 
| SF-36 Health Survey | a set of generic, coherent, and easily administered quality-of-life measures | measured at 6 months | 
| SF-36 Health Survey | a set of generic, coherent, and easily administered quality-of-life measures | measured at 12 months | 
| SF-36 Health Survey | a set of generic, coherent, and easily administered quality-of-life measures | measured at 18 months | 
| SF-36 Health Survey | a set of generic, coherent, and easily administered quality-of-life measures | measured at 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Facial Transplantation