RecruitingNot ApplicableNCT02818400

Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

5 participants

Start Date

Nov 1, 2009

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria1

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

Exclusion Criteria8

  • 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

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Interventions

PROCEDUREcomposite tissue allotransplantation

Locations(1)

CHU Amiens

Amiens, France

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NCT02818400


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