Face Reconstruction by Allotransplantation of Composite Tissues
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00527280
First received: September 5, 2007
Last updated: July 27, 2012
Last verified: September 2007
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Purpose
To show the feasibility of face transplantation in five patients
| Condition | Intervention | Phase |
|---|---|---|
|
Reconstruction of the Face |
Procedure: Feasibility ot face transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Face Reconstruction by Allotransplantation of Composite Tissues |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the potential benefit of such a transplantation in term of quality of life [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- To measure the impact of this improvement [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- To measure the impact of a immunosuppressive treatment for a pathology which is not vital [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 5 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Procedure: Feasibility ot face transplantation
Feasibility ot face transplantation
Other Name: 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. . s
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527280
Contacts
| Contact: Laurent LANTIERI, MD PhD | +33 (0) 1-49-81-21-11 | laurent.lantieri@hmn.aphp.fr |
Locations
| France | |
| Centre hospitalier Universaire Henri Mondor | Recruiting |
| Créteil, France, 94010 | |
| Contact: Laurent LANTIERI, MD PhD +33 (0) 1-49-81-21-11 Laurent.lantieri@hmn.aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Laurent LANTIERI, MD PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00527280 History of Changes |
| Other Study ID Numbers: | P050303 |
| Study First Received: | September 5, 2007 |
| Last Updated: | July 27, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Allotransplantation:composite tissue Face transplantation |
Additional relevant MeSH terms:
|
Facies Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013