Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Not Applicable

Recruiting

• Conditions: Surgery, Oral
• Interventions: Procedure: composite tissue allotransplantation

• Registration Number: NCT02818400
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems.

By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction.

In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach.

Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Patients with loss of unrepairable substance by conventional techniques shreds, at the front

Exclusion Criteria

• Facial lesions repaired by conventional reconstructive surgery techniques
• History of malignancy in remission for less than 5 years
• Malignant neoplasm undergoing changes
• Severe psychiatric history
• Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology)
• Patients above a grade 1 in the classification NYHA ( New York Heart Association )
• insufficient with renal creatinine clearance less than 70 mL / min or presence of a proteinuria
• Severe hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Composite tissue allotransplantation	composite tissue allotransplantation	-

Primary Outcome Measures

Name	Time	Method
functional recovery : motor recovery	1 year	labial contact allowing complete mouth closure
functional recovery : sensory recovery	1 year	sensitivity to heat and cold

Secondary Outcome Measures

Name	Time	Method
functional recovery : motor recovery	2 years, 5 years	labial contact allowing complete mouth closure
functional recovery : sensory recovery	2 years, 5 years	sensitivity to heat and cold

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France