Bilateral Allotransplantation of Upper Limbs

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00893698

Enrollment

Registered

2009-05-06

Start date

2009-01-31

Completion date

Unknown

Last updated

2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Private of Their Upper Limbs

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.

Interventions

PROCEDUREbilateral allotransplantation

bilateral allotransplantation of upper limbs

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities	6 years

Secondary

Measure	Time frame
Aesthetic and psychologic	6 years

Countries

France

Contacts

Primary ContactGuy Magalon

guy.magalon@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026