Bilateral Allotransplantation of Upper Limbs

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00893698
• Collaborator: (none)
• Enrollment: 5
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Private of Their Upper Limbs	Procedure: bilateral allotransplantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2009
• Anticipated Primary Completion Date: Jan 1, 2015

Outcome Measures

Primary Outcome Measures

1. 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

1. Aesthetic and psychologic [6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT00893698
• Other Study ID Numbers: 2008/17; 2008-A00516-49
• First Posted: May 6, 2009
• Last Update Posted: Aug 29, 2014
• Last Verified: Aug 1, 2014

Study Results

No Results Posted as of Aug 29, 2014