Human Composite Facial Allotransplantation

Transplantation: Facial Transplantation Clinical Trial

Official title:

Human Composite Facial Allotransplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117190
• Other study ID #: 028.TRN.2014.D
• Status: Completed
• Phase: N/A
• Start date: October 21, 2014
• Est. completion date: March 18, 2021

Study information

• Verified date: February 2022
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Facies
• Transplantation: Facial Transplantation

Intervention

Procedure:
• Facial Allotransplantation

Locations

Country	Name	City	State
United States	Methodist Health System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Facial Disability Index	a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders	measured at 6 weeks
Primary	Facial Disability Index	a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders	measured at 3 months
Primary	Facial Disability Index	a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders	measured at 6 months
Primary	Facial Disability Index	a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders	measured at 12 months
Primary	Facial Disability Index	a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders	measured at 18 months
Primary	Facial Disability Index	a disease-specific, self-report instrument for the assessment of disabilities of patients with facial nerve disorders	measured at 24 months
Primary	SF-36 Health Survey	a set of generic, coherent, and easily administered quality-of-life measures	measured at 6 weeks
Primary	SF-36 Health Survey	a set of generic, coherent, and easily administered quality-of-life measures	measured at 3 months
Primary	SF-36 Health Survey	a set of generic, coherent, and easily administered quality-of-life measures	measured at 6 months
Primary	SF-36 Health Survey	a set of generic, coherent, and easily administered quality-of-life measures	measured at 12 months
Primary	SF-36 Health Survey	a set of generic, coherent, and easily administered quality-of-life measures	measured at 18 months
Primary	SF-36 Health Survey	a set of generic, coherent, and easily administered quality-of-life measures	measured at 24 months