Craniomaxillofacial Allotransplantation

NCT02158793 | Terminated DMC

• 1 other identifier: 14-00550
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and evaluate the acceptance and function of the transplanted tissue. The aim of the transplant is to provide patient a more normal appearance . Additionally we aim to restore functioning, movement, and sensation of their face including that of the lips, mouth, and eyes.

Conditions

Facial Injuries

Keywords

face transplant; Craniomaxillofacial Allotransplantation; facial disfigurement; facial trauma

Outcome Measures

Primary Outcomes (1)

• Evaluate the success of the face transplant

  We will measure the restoration of function, sensation, and appearance of the transplanted facial segment. These will be measured using various multi-disciplinary evaluations including swallow studies, photography, speech therapy evaluation, Occupational therapy evaluation, electromyogram (EMG) , Nerve Conduction Study (NCS), CT Angiogram, Functional ( Magnetic Resononance Image) MRI, vision exams, pathology samples to check for rejection, Blood tests

  Monthly for 6 months, every 6 months for 2 years, then annually up to year 5

Secondary Outcomes (1)

• Evaluate psychological effects of receiving a face transplant

  Monthly for 6 months, every 6 months for 2 years, then annually until year 5

Study Arms (1)

Face Transplant recipient

EXPERIMENTAL

Single Arm study, all participants will receive Craniomaxillofacial allotransplantation

Procedure: Craniomaxillofacial allotransplantation

Interventions

Craniomaxillofacial allotransplantation PROCEDURE

Transplantation of donor face

Face Transplant recipient

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated all required IRB approved consent forms
• Male or female recipient between the ages of 18-64 years. \* Recipients do not need to be same gender as donor\*
• Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.
• Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.
• Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery
• The subject is able to complete pre-transplant examination and screening procedures.
• Patient has been approved by Patient Selection Committee for placement on the recipient waiting list
• The subject is willing to continue immunosuppression regimen as directed by treating physician.
• Subject is willing and able to return to follow-up visits as described in treatment plan.
• Subjects must have autogenous tissue options available for reconstruction in event of graft failure.
• Normal GFR (glomerular filtration rate) \>60
• Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.

You may not qualify if:

• Subject has an uncontrolled infection
• Serious co-morbidities
• Positive serology for HIV; Hepatitis B/C Antigen
• Subject has active substance abuse/ alcoholism
• Active Severe Psychiatric Illness
• Cognitive limitations affecting the patient's ability to provide informed consent
• Recent history of medical nonadherence
• Unstable social situation as evidence by lack of stable housing and/or lack of a supportive significant other.
• Recent history of medical non-adherence.
• Lack of stable housing and/or supportive significant other/caregiver throughout all phases of the study
• Currently active smoker within 1 year
• Subjects with any cognitive deficits related to a TBI (traumatic brain injury) and or any organic neurological disorders will not be considered for this protocol.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Facial Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Eduardo Rodriguez, MD, DDS

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)