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Craniomaxillofacial Allotransplantation

Primary Purpose

Facial Injuries

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Craniomaxillofacial allotransplantation

About this trial

This is an interventional treatment trial for Facial Injuries focused on measuring face transplant, Craniomaxillofacial Allotransplantation, facial disfigurement, facial trauma

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

Subject has an uncontrolled infection
Serious co-morbidities
Positive serology for HIV; Hepatitis B/C Antigen
Active malignancy within 5 years with the exclusion of non-melanoma
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.

Sites / Locations

NYU Langone Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Face Transplant recipient

Arm Description

Single Arm study, all participants will receive Craniomaxillofacial allotransplantation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate psychological effects of receiving a face transplant

Psychological outcome will be measured using patient reported outcome tools such as MoCA; BIDQ; SF-36; PHQ-9

Full Information

NCT ID

NCT02158793

First Posted

June 5, 2014

Last Updated

August 28, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02158793

Brief Title

Craniomaxillofacial Allotransplantation

Official Title

Craniomaxillofacial Allotransplantation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 2014 (Actual)

Primary Completion Date

September 2027 (Anticipated)

Study Completion Date

September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is to perform facial transplants in patients with severe facial deformities or facial wounds from traumatic injuries. The transplant is to help reconstruct a person's damaged face. 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. There are some procedures in plastic and reconstructive surgery that can repair the look of a patient's face, but often can't replace the movement and use of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. Conventional reconstruction method requires multiple surgeries in order to form and shape the transplanted tissue. Because this type of reconstruction is limited, it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face. This study uses a composite tissue allograft , or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants. The damaged parts of the face could return movement as well. Transplanted patients are required to take lifelong immunosuppression drugs which have risks, which are still a consideration when deciding to choose this option for correcting severe facial deformities. We will conduct the surgery and prospectively follow the patient to monitor signs of rejection of the transplanted face. Additionally, patients will be constantly evaluated for clinical and functional outcomes and ensure that optimal results are achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Injuries

Keywords

face transplant, Craniomaxillofacial Allotransplantation, facial disfigurement, facial trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Face Transplant recipient

Arm Type

Experimental

Arm Description

Single Arm study, all participants will receive Craniomaxillofacial allotransplantation

Intervention Type

Procedure

Intervention Name(s)

Craniomaxillofacial allotransplantation

Intervention Description

Transplantation of donor face

Primary Outcome Measure Information:

Title

Evaluate the success of the face transplant

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Evaluate psychological effects of receiving a face transplant

Description

Psychological outcome will be measured using patient reported outcome tools such as MoCA; BIDQ; SF-36; PHQ-9

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: Subject has an uncontrolled infection Serious co-morbidities Positive serology for HIV; Hepatitis B/C Antigen Active malignancy within 5 years with the exclusion of non-melanoma 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas Calahan

Phone

(929) 455-5826

Thomas.Calahan@nyulangone.org

First Name & Middle Initial & Last Name or Official Title & Degree

Aimee Chow

Phone

(212) 263-4355

Aimee.Chow@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Rodriguez, MD, DDS

Organizational Affiliation

NYU Langone Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Sweeney, NP

Phone

646-501-4464

Nicole.Sweeney@nyumc.org

First Name & Middle Initial & Last Name & Degree

Tiffany Drummond, BS

Phone

212-263-4867

tiffany.drummond@nyumc.org

First Name & Middle Initial & Last Name & Degree

Eduardo D Rodriguez, MD, DDS

First Name & Middle Initial & Last Name & Degree

Alexes Hazen, MD

First Name & Middle Initial & Last Name & Degree

Daniel Ceradini, MD

First Name & Middle Initial & Last Name & Degree

Jamie Levine, MD

First Name & Middle Initial & Last Name & Degree

Pierre Saadeh, MD

First Name & Middle Initial & Last Name & Degree

Bruce Gelb, MD

12. IPD Sharing Statement

Learn more about this trial

Craniomaxillofacial Allotransplantation

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