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Bilateral Allotransplantation of Upper Limbs

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ClinicalTrials.gov Identifier: NCT00893698
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : May 6, 2009
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patients Private of Their Upper Limbs Procedure: bilateral allotransplantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2009
Estimated Primary Completion Date : January 2015

Intervention Details:
  • Procedure: bilateral allotransplantation
    bilateral allotransplantation of upper limbs


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Aesthetic and psychologic [ Time Frame: 6 years ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00893698     History of Changes
Other Study ID Numbers: 2008/17
2008-A00516-49
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014