Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

NCT02818400 | Unknown

• 1 other identifier: PHRCN06-PR-DEVAUCHELLE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.).

Conditions

Surgery, Oral

Keywords

maxillofacial surgery; face graft; composite tissue; stem cell infusion; allotransplantation; microsurgery

Outcome Measures

Primary Outcomes (3)

• functional recovery : motor recovery

  labial contact allowing complete mouth closure

  1 year

• functional recovery : sensory recovery

  Sensitivity to light touch, as assessed with the use of static monofilaments

  1 year

• functional recovery : sensory recovery

  sensitivity to heat and cold

  1 year

Secondary Outcomes (3)

• functional recovery : motor recovery

  2 years, 5 years

• functional recovery : sensory recovery

  2 years, 5 years

• functional recovery : sensory recovery

  2 years, 5 years

Study Arms (1)

Composite tissue allotransplantation

EXPERIMENTAL

Procedure: composite tissue allotransplantation

Interventions

composite tissue allotransplantation PROCEDURE

Composite tissue allotransplantation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Interventions

Vascularized Composite Allotransplantation

Intervention Hierarchy (Ancestors)

Organ Transplantation; Transplantation; Surgical Procedures, Operative; Transplantation, Homologous

Study Officials

• Bernard DEVAUCHELLE, Md, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernard DEVAUCHELLE, Md, PhD

CONTACT

+33 3 22 08 90 71; devauchelle.bernard@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 29, 2016
• Study Start: November 1, 2009
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)