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Recruiting Not applicable

Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

NCT02818400 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2009-11
Last updated
2026-05-13

Condition(s) studied

Surgery, Oral

Investigational drug(s) / intervention(s)

composite tissue allotransplantation

Study 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.).

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02818400 on ClinicalTrials.gov ↗ ← All trials in France