Human Composite Facial Allotransplantation

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

Study Overview

• Status: Completed
• Conditions: Transplantation: Facial Transplantation
• Intervention / Treatment: Procedure: Facial Allotransplantation

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Facial Deformity; Face not the normal shape because of injury or illness.	Procedure: Facial Allotransplantation

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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Likith V. Reddy, MD, Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2014
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Facial Transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: 028.TRN.2014.D