Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation (AFTC)

February 7, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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.).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Composite tissue allotransplantation
Procedure: composite tissue allotransplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional recovery : motor recovery
Time Frame: 1 year
labial contact allowing complete mouth closure
1 year
functional recovery : sensory recovery
Time Frame: 1 year
Sensitivity to light touch, as assessed with the use of static monofilaments
1 year
functional recovery : sensory recovery
Time Frame: 1 year
sensitivity to heat and cold
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Bernard DEVAUCHELLE, Md, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PHRCN06-PR-DEVAUCHELLE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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