Clinical trial NCT00527280: Face Reconstruction by Allotransplantation of Composite Tissues
Official title: Face Reconstruction by Allotransplantation of Composite Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reconstruction of the Face
Keywords: Allotransplantation:composite tissue
Face transplantation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To show the feasibility of face transplantation in patients

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 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

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.
timeFrame: during the study
Secondary outcomes:
measure: To evaluate the potential benefit of such a transplantation in term of quality of life
timeFrame: during the study
measure: To measure the impact of this improvement
timeFrame: during the study
measure: To measure the impact of a immunosuppressive treatment for a pathology which is not vital
timeFrame: during the study
measure: 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
timeFrame: at in the following days weeks and month after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital européen Geroges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent LANTIERI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lantieri L, Grimbert P, Ortonne N, Suberbielle C, Bories D, Gil-Vernet S, Lemogne C, Bellivier F, Lefaucheur JP, Schaffer N, Martin F, Meningaud JP, Wolkenstein P, Hivelin M. Face transplant: long-term follow-up and results of a prospective open study. Lancet. 2016 Oct 1;388(10052):1398-1407. doi: 10.1016/S0140-6736(16)31138-2. Epub 2016 Aug 25.