Bilateral Allotransplantation of Upper Limbs

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Patients Private of Their Upper Limbs

Treatments: Procedure: bilateral allotransplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00893698

2008/17

2008-A00516-49

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)