Clinical trial NCT02818400: Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
Official title: Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery, Oral
Keywords: maxillofacial surgery
face graft
composite tissue
stem cell infusion
allotransplantation
microsurgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.).


Eligibility criteria: 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 outcomes:
measure: functional recovery : motor recovery
timeFrame: 1 year
measure: functional recovery : sensory recovery
timeFrame: 1 year
measure: functional recovery : sensory recovery
timeFrame: 1 year
Secondary outcomes:
measure: functional recovery : motor recovery
timeFrame: 2 years, 5 years
measure: functional recovery : sensory recovery
timeFrame: 2 years, 5 years
measure: functional recovery : sensory recovery
timeFrame: 2 years, 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Bernard DEVAUCHELLE, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: