Face Reconstruction by Allotransplantation of Composite Tissues

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00527280
First received: September 5, 2007
Last updated: January 10, 2014
Last verified: September 2007
  Purpose

To show the feasibility of face transplantation in patients


Condition Intervention Phase
Reconstruction of the Face
Procedure: Feasibility ot face transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Face Reconstruction by Allotransplantation of Composite Tissues

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the potential benefit of such a transplantation in term of quality of life [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • To measure the impact of this improvement [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • To measure the impact of a immunosuppressive treatment for a pathology which is not vital [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: January 2007
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Feasibility ot face transplantation
Feasibility ot face transplantation
Other Name: 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.

  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 corticoid
  • 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
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: NCT00527280

Locations
France
Hopital européen Geroges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent LANTIERI, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00527280     History of Changes
Other Study ID Numbers: P050303
Study First Received: September 5, 2007
Last Updated: January 10, 2014
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014