Face Reconstruction by Allotransplantation of Composite Tissues

March 21, 2017 updated by: Assistance Publique - Hôpitaux de Paris
To show the feasibility of face transplantation in patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Européen Geroges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: Feasibility ot face transplantation
Feasibility ot face transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the potential benefit of such a transplantation in term of quality of life
Time Frame: during the study
during the study
To measure the impact of this improvement
Time Frame: during the study
during the study
To measure the impact of a immunosuppressive treatment for a pathology which is not vital
Time Frame: during the study
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
at in the following days weeks and month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Laurent LANTIERI, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P050303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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