Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

NCT00213837

Otorhinolaryngologic Diseases

COMPLETED PHASE2

Influence of the Implant Connection on Facial Tissues Maturation

NCT04160689

Bone Loss Periodontal Bone Loss Implant Tissue Failure

COMPLETED PHASE4

Jawline Improvement Using Patient-specific Angle Implants With Virtual Planning in Orthognathic Surgery

NCT06235138

Malocclusion

COMPLETED

Evaluation of Using 3D Printed PEEK Facial Implants in Repairing Maxillofacial Deformities

NCT05348434

Maxillofacial Trauma Face Cancer Mucormycosis

COMPLETED

Implant Survival and Peri-abutment Tissue Reactions of Extra-oral Implants.

NCT03182361

Maxillofacial Prosthesis Implantation Extra-oral Implants Extra-oral Prosthesis +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery, Oral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Composite tissue allotransplantation

Group Type EXPERIMENTAL

composite tissue allotransplantation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

composite tissue allotransplantation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No