Hand Transplantation for the Reconstruction of Below the Elbow Amputations
Stopped early · Not applicable
Conditions studied: Amputation, Transplantation
In brief
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) {a.k.a. composite tissue allotransplantation} is the term used to describe transplantation of multiple tissues (skin, muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit (e.g. hand). Several recent advances in clinical organ transplant immunosuppression and experimental limb VCA have now made it feasible to consider clinical VCA for the functional restoration of patients with loss of one or both hands. This protocol facilitates the development of limb VCA at the Atlanta Veterans Affairs Medical Center (VAMC) and at Emory University for patients with below the elbow amputations. It will evaluate the patients' use of transplanted limb(s) in activities of daily living and compare the function of the transplanted hand to the function with their previous prosthesis. Patients with below the elbow amputations will be enrolled. Donor tissue will be recovered from deceased donors following the guidelines of and in cooperation with the regional Organ Procurement Organization. The transplantation procedure and postoperative care will be performed using the standard technique for limb replantation. Patients will receive standard immunosuppressive regimen. Rejections will be treated in keeping with experience from the solid organ transplant experience. Graft failure will be treated with allograft amputation.
Key facts
- Study ID
- NCT00778856
- Run by
- Emory University
- People needed
- 19
- Starts
- 2008-09-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2015-03-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- male or female, 18-55 years of age, with below elbow amputation
- ability to give informed consent
You may not qualify if…
- 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
Where it is running
- Veterans Affairs Medical Center — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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