Face Reconstruction by Allotransplantation of Composite Tissues

To show the feasibility of face transplantation in patients

Study Overview

• Status: Completed
• Conditions: Reconstruction of the Face
• Intervention / Treatment: Procedure: Feasibility ot face transplantation

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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.	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	during the study
To measure the impact of this improvement	during the study
To measure the impact of a immunosuppressive treatment for a pathology which is not vital	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	at in the following days weeks and month after surgery

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

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: Allotransplantation:composite tissue; Face transplantation
• Other Study ID Numbers: P050303