Bilateral Allotransplantation of Upper Limbs

August 28, 2014 updated by: Assistance Publique Hopitaux De Marseille

The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.

Study Overview

Status

Unknown

Conditions

Patients Private of Their Upper Limbs

Intervention / Treatment

Procedure: bilateral allotransplantation

Study Type

Interventional

Enrollment (Anticipated)

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 Locations

France
- - Marseille, France, 13354
    - Recruiting
    - Assistance Publique Hôpitaux de Marseille
    - Contact:
      
      guy MAGALON

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Donor:

State of brain death
Compatibility with recipient about sex, size, age and color
Blood compatibility; integrity of upper limbs

Recipient:

Double amputation of hands or forearms with traumatic origin
Personal motivation
Good health condition
Delay from 2 months to 34 years between amputation and transplantation

Exclusion Criteria:

Donor:

Uncompatibility with sample
Lesion on upper limbs
Neoplasia
Hepatitis B or C
Positive CMV serology

Recipient:

Uncompatibility with immunosuppressant treatment
Psychosis
Carcinosis
Cardiovascular diseases
Addiction to alcohol or smoking
Pregnancy
Feeding

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: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities Time Frame: 6 years	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Aesthetic and psychologic Time Frame: 6 years	6 years

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

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

January 1, 2009

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria