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Craniomaxillofacial Allotransplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02158793
Recruitment Status : Recruiting
First Posted : June 9, 2014
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Facial Injuries Procedure: Craniomaxillofacial allotransplantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Craniomaxillofacial Allotransplantation
Study Start Date : June 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Face Transplant recipient
Single Arm study, all participants will receive Craniomaxillofacial allotransplantation
Procedure: Craniomaxillofacial allotransplantation
Transplantation of donor face

Primary Outcome Measures :
  1. Evaluate the success of the face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5 ]

    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 :
  1. Evaluate psychological effects of receiving a face transplant [ Time Frame: Monthly for 6 months, every 6 months for 2 years, then annually until year 5 ]
    Psychological outcome will be measured using patient reported outcome tools such as MoCA; BIDQ; SF-36; PHQ-9

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02158793

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Contact: Nicole Sweeney, NP (646) 501-4464
Contact: Kristen Fernandez (646) 501-4401

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United States, New York
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Nicole Sweeney, NP    646-501-4464   
Contact: Tiffany Drummond, BS    212-263-4867   
Principal Investigator: Eduardo D Rodriguez, MD, DDS         
Sub-Investigator: Alexes Hazen, MD         
Sub-Investigator: Daniel Ceradini, MD         
Sub-Investigator: Jamie Levine, MD         
Sub-Investigator: Pierre Saadeh, MD         
Sub-Investigator: Bruce Gelb, MD         
Sponsors and Collaborators
New York University School of Medicine
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Principal Investigator: Eduardo Rodriguez, MD, DDS NYU Langone Medical Center

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Responsible Party: New York University School of Medicine Identifier: NCT02158793     History of Changes
Other Study ID Numbers: 14-00550
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Keywords provided by New York University School of Medicine:
face transplant
Craniomaxillofacial Allotransplantation
facial disfigurement
facial trauma

Additional relevant MeSH terms:
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Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries