NCT02818400 Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
| NCT ID | NCT02818400 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Surgery, Oral |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2009-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2009-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Bernard DEVAUCHELLE, Md, PhD
PRINCIPAL INVESTIGATOR
CHU Amiens
Frequently Asked Questions
Who can join the NCT02818400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Surgery, Oral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02818400 currently recruiting?
Yes, NCT02818400 is actively recruiting participants. Contact the research team at devauchelle.bernard@chu-amiens.fr for enrollment information.
Where is the NCT02818400 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT02818400 clinical trial?
NCT02818400 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Bernard DEVAUCHELLE, Md, PhD at CHU Amiens. The trial plans to enroll 5 participants.