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NCT Number: NCT02818400

Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

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.).

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

composite tissue allotransplantation

Procedure

Primary outcomes

  1. functional recovery : motor recovery

    Time frame: 1 year

    labial contact allowing complete mouth closure

  2. functional recovery : sensory recovery

    Time frame: 1 year

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

  3. functional recovery : sensory recovery

    Time frame: 1 year

    sensitivity to heat and cold

Secondary outcomes

  1. functional recovery : motor recovery

    Time frame: 2 years, 5 years

    labial contact allowing complete mouth closure

  2. functional recovery : sensory recovery

    Time frame: 2 years, 5 years

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

  3. functional recovery : sensory recovery

    Time frame: 2 years, 5 years

    sensitivity to heat and cold

Study contacts

Contact information is provided by the study sponsor or research team.

Bernard DEVAUCHELLE, Md, PhD

CONTACT

[email protected]

+33 3 22 08 90 71

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: AFTC

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2016
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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