Face Reconstruction by Allotransplantation of Composite Tissues

NCT ID: NCT00527280

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2016-05-31

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.

Conditions

Reconstruction of the Face

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Feasibility ot face transplantation

Intervention Type: PROCEDURE

Feasibility ot face transplantation

Interventions

Feasibility ot face transplantation

Feasibility ot face transplantation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent LANTIERI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital européen Geroges Pompidou

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27567680 (View on PubMed)

Other Identifiers

P050303

Identifier Type: -

Identifier Source: org_study_id