Face Transplantation for Treatment of Severe Facial Deformity

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bodhan Pomahac, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01281267
First received: January 20, 2011
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

Face transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. Face transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with severe facial injuries. The purpose of this study is to develop the best practices for facial transplantation that will improve the outcomes of future face transplant recipients.


Condition Intervention
Severe Facial Deformity
Procedure: Facial Allograft Transplantation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Outcomes of face transplantation. [ Time Frame: Subjects will be followed for 18 months after face transplantation ] [ Designated as safety issue: No ]
    We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.


Secondary Outcome Measures:
  • Efficacy and optimization of the immune suppression protocol. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will evaluate the cost-effectiveness of face transplantation.


Estimated Enrollment: 10
Study Start Date: September 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • face transplantation
  • facial transplantation
  • composite facial allograft transplantation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 60 years.
  • Loss of a major part of the face, such as the nose or the lips, or at least 25% of the facial tissue.
  • The facial defect cannot be restored with traditional reconstruction techniques.
  • Signed written informed consent.
  • Willing to complete psychological and social evaluations.
  • Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
  • Willing to return for follow-up visits as determined by the treating physician and to comply with extensive post-transplant rehabilitation therapy.
  • Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.

Exclusion Criteria:

  • Active malignancy.
  • High risk of return of malignancy.
  • History of persistent non-compliance.
  • Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
  • Any diagnosis that puts the subject at risk during the face transplant surgery.
  • Absence of adequate donor sites for skin grafting in the event of transplant failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281267

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Quinn    617-732-5303    lquinn1@partners.org   
Principal Investigator: Bohdan Pomahac, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bodhan Pomahac, Medical Director, Burn Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01281267     History of Changes
Other Study ID Numbers: 2008P000550, W911QY09C0216
Study First Received: January 20, 2011
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
facial transplantation
face transplantation
composite tissue allotransplantation
CTA
composite tissue allograft
facial allograft

Additional relevant MeSH terms:
Congenital Abnormalities
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014