Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Study Overview
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Brief Summary
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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.).

Official Title
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Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Conditions
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Surgery, Oral

Intervention / Treatment
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* Procedure: composite tissue allotransplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Composite tissue allotransplantation<br> | Procedure: composite tissue allotransplantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional recovery : motor recovery | labial contact allowing complete mouth closure | 1 year | 
| functional recovery : sensory recovery | Sensitivity to light touch, as assessed with the use of static monofilaments | 1 year | 
| functional recovery : sensory recovery | sensitivity to heat and cold | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional recovery : motor recovery | labial contact allowing complete mouth closure | 2 years, 5 years | 
| functional recovery : sensory recovery | Sensitivity to light touch, as assessed with the use of static monofilaments | 2 years, 5 years | 
| functional recovery : sensory recovery | sensitivity to heat and cold | 2 years, 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillofacial surgery, face graft, composite tissue, stem cell infusion, allotransplantation, microsurgery