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|ClinicalTrials.gov Identifier: NCT02158793|
Recruitment Status : Recruiting
First Posted : June 9, 2014
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Facial Injuries||Procedure: Craniomaxillofacial allotransplantation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Craniomaxillofacial Allotransplantation|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Face Transplant recipient
Single Arm study, all participants will receive Craniomaxillofacial allotransplantation
Procedure: Craniomaxillofacial allotransplantation
Transplantation of donor face
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02158793
|Contact: Nicole Sweeney, NP||(646) 501-4464||Nicole.Sweeney@nyumc.org|
|Contact: Kristen Fernandez||(646) 501-4401||Kristen.Fernandez@nyumc.org|
|United States, New York|
|NYU Langone Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Nicole Sweeney, NP 646-501-4464 Nicole.Sweeney@nyumc.org|
|Contact: Tiffany Drummond, BS 212-263-4867 email@example.com|
|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|
|Principal Investigator:||Eduardo Rodriguez, MD, DDS||NYU Langone Medical Center|