Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Surgery, Oral Clinical Trial

— AFTC  

Official title:

Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02818400
• Other study ID #: PHRCN06-PR-DEVAUCHELLE
• Status: Recruiting
• Phase: N/A
• Start date: November 2009
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Bernard DEVAUCHELLE, Md, PhD
• Phone: +33 3 22 08 90 71
• Email: devauchelle.bernard[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery, Oral

Intervention

Procedure:
• composite tissue allotransplantation

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional recovery : motor recovery	labial contact allowing complete mouth closure	1 year
Primary	functional recovery : sensory recovery	Sensitivity to light touch, as assessed with the use of static monofilaments	1 year
Primary	functional recovery : sensory recovery	sensitivity to heat and cold	1 year
Secondary	functional recovery : motor recovery	labial contact allowing complete mouth closure	2 years, 5 years
Secondary	functional recovery : sensory recovery	Sensitivity to light touch, as assessed with the use of static monofilaments	2 years, 5 years
Secondary	functional recovery : sensory recovery	sensitivity to heat and cold	2 years, 5 years