Status:
TERMINATED
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
Lead Sponsor:
Emory University
Conditions:
Amputation
Transplantation
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung. Vascularized Composite Allotransplantation (VCA)...
Detailed Description
This protocol will study patients with below the elbow amputations who are selected to undergo limb allotransplantation. We will study patients after they have been trained on the use of a prosthetic ...
Eligibility Criteria
Inclusion
- male or female, 18-55 years of age, with below elbow amputation
- ability to give informed consent
Exclusion
- Any condition that precludes serial follow-up.
- Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing these are appropriately eliminated prior to transplant. For amputations due to malignancy, 5 years recurrence free survival will be required prior to enrollment.
- Any known immunodeficiency syndrome.
- Inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services
- Pregnancy or unwillingness to practice birth control methods during the first year of the study.
- Unwillingness to undergo blood transfusion if clinically indicated
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00778856
Start Date
September 1 2008
End Date
March 1 2013
Last Update
March 27 2015
Active Locations (2)
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1
Veterans Affairs Medical Center
Atlanta, Georgia, United States, 30033
2
Emory University
Atlanta, Georgia, United States, 30322