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Face Reconstruction by Allotransplantation of Composite Tissues

This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, September 2007

Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00527280
  Purpose

To show the feasibility of face transplantation in five patients


Condition Intervention Phase
for the Reconstruction of the Face
Procedure: Feasibility ot face transplantation
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Face Reconstruction by Allotransplantation of Composite Tissues

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids. [ Time Frame: during the study ]

Secondary Outcome Measures:
  • To evaluate the potential benefit of such a transplantation in term of quality of life [ Time Frame: during the study ]
  • To measure the impact of this improvement [ Time Frame: during the study ]
  • To measure the impact of a immunosuppressive treatment for a pathology which is not vital [ Time Frame: during the study ]
  • To evaluate Acute Graft rejection using skin and mucosa biopsies: function of the lips and or eyelids mobility and function of the orbicularis muscles Quality of life the psychiatric and psychological evaluations [ Time Frame: at in the following days weeks and month after surgery ]

Estimated Enrollment:   5
Study Start Date:   January 2007
Estimated Study Completion Date:   January 2014

Arms Assigned Interventions
1: Experimental Procedure: Feasibility ot face transplantation

Detailed Description:

Most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. The study was designed following the advice of the French National Ethics Advisory Committee for life sciences and health (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression. . s

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Age 18 through 65 years
  • Signed written informed consent
  • patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid.
  • validation of the feasibility by a committee of expert in plastic surgery and maxillofacial
  • patient with a positive psychologic evaluation
  • patient with an anatomical evaluation and assessment pretransplantation positive normal infectious assessment
  • Good compliance and capacity of adaptation to the assessment difficulties
  • Patient with renal, hepatic, hematologic ,cardiac normal
  • Patient profiting from a Social Security cover
  • Patient informed patient, having signed a free assent lit with inclusion in the study

Exclusion Criteria:

  • patient minor under supervision or deprived of freedom by court order or administrative.
  • person remaining in a medical or social establishment
  • pregnant. or breast-feeding women
  • patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational
  • patient presenting a hepatic pathology
  • Any cancer that has been in complete remission for > 5 years malignancies tumoral lesion of the face with 2 years deadline of remission respected renal insufficiency chronic clearance of creatin < 60l ml/mn
  • chronic respiratory insufficiency
  • patient presenting an active infection which can be worsened by the immunosuppression
  • patient presenting an active infection which can be worsened by the corticoïd
  • patient with affection being able to compromise post-operative survival
  • patient with digestive ulcer
  • No known HIV infection
  • serology hepatitis B with circulating DNA highlighted quantitatively
  • personality emotional unstable
  • schizophrenic or not schizophrenic psychosis
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527280

Contacts
Contact: Laurent LANTIERI, MD PhD     +33 (0) 1-49-81-21-11     laurent.lantieri@hmn.aphp.fr    

Locations
France
Centre hospitalier Universaire Henri Mondor     Recruiting
      Créteil, France, 94010
      Contact: Laurent LANTIERI, MD PhD     +33 (0) 1-49-81-21-11     Laurent.lantieri@hmn.aphp.fr    

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Investigators
Principal Investigator:     Laurent LANTIERI, MD PhD     Assistance Publique - Hôpitaux de Paris    
  More Information


Study ID Numbers:   P050303
First Received:   September 5, 2007
Last Updated:   September 6, 2007
ClinicalTrials.gov Identifier:   NCT00527280
Health Authority:   France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Allotransplantation:composite tissue  
Face transplantation  

Study placed in the following topic categories:
Facies

ClinicalTrials.gov processed this record on October 16, 2008




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