Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation (AFTC)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Surgery, Oral

Treatments: Procedure: composite tissue allotransplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02818400

PHRCN06-PR-DEVAUCHELLE

Details and patient eligibility

About

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.).

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Composite tissue allotransplantation

Experimental group

Treatment:

Procedure: composite tissue allotransplantation