Bilateral Allotransplantation of Upper Limbs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients Private of Their Upper Limbs
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •State of brain death
- •Compatibility with recipient about sex, size, age and color
- •Blood compatibility; integrity of upper limbs
- •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
- •Uncompatibility with sample
- •Lesion on upper limbs
- •Neoplasia
- •Hepatitis B or C
- •Positive CMV serology
- •Uncompatibility with immunosuppressant treatment
- •Psychosis
- •Carcinosis
- •Cardiovascular diseases
- •Addiction to alcohol or smoking
Outcomes
Primary Outcomes
Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities
Time Frame: 6 years
Secondary Outcomes
- Aesthetic and psychologic(6 years)