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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT02818400

Collaborator

(none)

Enrollment

Location

Arm

181

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.).

Condition or Disease	Intervention/Treatment	Phase
Surgery, Oral	Procedure: composite tissue allotransplantation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Composite tissue allotransplantation	Procedure: composite tissue allotransplantation

Arm

Intervention/Treatment

Experimental: Composite tissue allotransplantation

Procedure: composite tissue allotransplantation

Outcome Measures

Primary Outcome Measures

functional recovery : motor recovery [1 year]
labial contact allowing complete mouth closure
functional recovery : sensory recovery [1 year]
Sensitivity to light touch, as assessed with the use of static monofilaments
functional recovery : sensory recovery [1 year]
sensitivity to heat and cold

Secondary Outcome Measures

functional recovery : motor recovery [2 years, 5 years]
labial contact allowing complete mouth closure
functional recovery : sensory recovery [2 years, 5 years]
Sensitivity to light touch, as assessed with the use of static monofilaments
functional recovery : sensory recovery [2 years, 5 years]
sensitivity to heat and cold

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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