Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02818400

Acronym

AFTC

Enrollment

Registered

2016-06-29

Start date

2009-11-01

Completion date

2026-12-01

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery, Oral

Keywords

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

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.).

Interventions

PROCEDUREcomposite tissue allotransplantation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
functional recovery : motor recovery	2 years, 5 years	labial contact allowing complete mouth closure
functional recovery : sensory recovery	2 years, 5 years	Sensitivity to light touch, as assessed with the use of static monofilaments

Countries

France

Contacts

CONTACTBernard DEVAUCHELLE, Md, PhD

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

PRINCIPAL_INVESTIGATORBernard DEVAUCHELLE, Md, PhD

CHU Amiens

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026