Face Reconstruction by Allotransplantation of Composite Tissues

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 2

Conditions

Reconstruction of the Face

Treatments

Procedure: Feasibility ot face transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00527280

P050303

Details and patient eligibility

About

To show the feasibility of face transplantation in patients

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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