Bilateral Allotransplantation of Upper Limbs

Not Applicable

• Conditions: Patients Private of Their Upper Limbs

• Registration Number: NCT00893698
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Study First Posted: 2009-05-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities	6 years

Secondary Outcome Measures

Name	Time	Method
Aesthetic and psychologic	6 years

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France