Bilateral Allotransplantation of Upper Limbs

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00893698
First received: May 5, 2009
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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 Intervention
Patients Private of Their Upper Limbs
Procedure: bilateral allotransplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Aesthetic and psychologic [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: January 2009
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: bilateral allotransplantation
    bilateral allotransplantation of upper limbs
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893698

Contacts
Contact: Guy Magalon guy.magalon@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: guy MAGALON         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00893698     History of Changes
Other Study ID Numbers: 2008/17, 2008-A00516-49
Study First Received: May 5, 2009
Last Updated: March 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on July 20, 2014