Overview

This trial is active, not recruiting.

Condition reconstruction of the face
Treatment feasibility ot face transplantation
Phase phase 2
Sponsor Assistance Publique - Hôpitaux de Paris
Start date January 2007
End date January 2014
Trial size 5 participants
Trial identifier NCT00527280, P050303

Summary

To show the feasibility of face transplantation in patients

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
feasibility ot face transplantation Feasibility ot face transplantation
Feasibility ot face transplantation

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Face Reconstruction by Allotransplantation of Composite Tissues
Principal investigator Laurent LANTIERI, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.