Facial Injuries Clinical Trial
Official title:
Craniomaxillofacial Allotransplantation
NCT number | NCT02158793 |
Other study ID # | 14-00550 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | September 2027 |
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 2027 |
Est. primary completion date | September 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | Monthly for 6 months, every 6 months for 2 years, then annually until year 5 |
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