CClinicalTrials.gg
Status unknownNCT00893698Updated Aug 29, 2014

Bilateral Allotransplantation of Upper Limbs

An interventional study of bilateral allotransplantation in Patients Private of Their Upper Limbs, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Patients Private of Their Upper Limbs
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Interventions

  • Procedurebilateral allotransplantation

    bilateral allotransplantation of upper limbs

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Aesthetic and psychologic

    Time frame: 6 years

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
    • guy MAGALON · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00893698
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
May 6, 2009
Start date
Jan 2009
Primary completion
Jan 2015 (estimated)
Last update
Aug 29, 2014

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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