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Bilateral Allotransplantation of Upper Limbs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: May 5, 2009
Last updated: August 28, 2014
Last verified: August 2014
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: None (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 ]

Secondary Outcome Measures:
  • Aesthetic and psychologic [ Time Frame: 6 years ]

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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 identifier: NCT00893698

Contact: Guy Magalon

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

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT00893698     History of Changes
Other Study ID Numbers: 2008/17
Study First Received: May 5, 2009
Last Updated: August 28, 2014 processed this record on September 21, 2017