Face Transplantation for Treatment of Severe Facial Deformity
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|ClinicalTrials.gov Identifier: NCT01281267|
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : January 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Severe Facial Deformity||Procedure: Facial Allograft Transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation|
|Actual Study Start Date :||September 1, 2009|
|Actual Primary Completion Date :||October 31, 2019|
|Actual Study Completion Date :||November 12, 2019|
|Experimental: Face transplantation||
Procedure: Facial Allograft Transplantation
Facial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity.
- Outcomes of face transplantation. [ Time Frame: Subjects will be followed for 18 months after face transplantation ]We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.
- Efficacy and optimization of the immune suppression protocol. [ Time Frame: 18 months ]We will evaluate the risks of rejection or likelihood of tolerance induction by measuring specific parameters in the blood or tissue, including: Serum alloantibodies concentration, numbers/phenotype of specific T cell alloreactivity in the peripheral blood, phenotypic characterization of graft infiltrating cells and local gene expression of cells and cytokines.
- Procedural outcomes of face transplantation [ Time Frame: From subject recruitment to 18 months after transplantation ]We will optimize the screening, pre-operative, peri-operative and follow-up procedures of face transplantation.
- Functional outcomes of face transplantation [ Time Frame: Subjects will be followed for 18 months following face transplantation ]We will evaluate the return of facial sensory and motor function after face transplantation.
- Psychosocial outcomes of face transplantation [ Time Frame: Subjects will be followed up for 18 months following face transplantation ]We will evaluate the psychological and social outcomes of face transplantation by evaluating the subject's quality of life at various time points before and after transplantation.
- Financial and economic aspects of face transplantation [ Time Frame: Subjects will be followed for 18 months after face transplantation ]We will evaluate the cost-effectiveness of face transplantation.
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): NCT01281267
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Bohdan Pomahac, MD||Brigham and Women's Hospital|