Hand Transplantation for the Reconstruction of Below the Elbow Amputations (VCA-01)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Amputation Transplantation |
Procedure: Hand transplantation |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hand Transplantation for the Reconstruction of Below the Elbow Amputations |
- Ability-relative to prosthetic limbs-to use the transplanted limb in activities of daily living, measured by quantitative functional tests [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Incidence of hand allograft rejection [ Time Frame: on-going ] [ Designated as safety issue: Yes ]
- Development/presence of alloantibodies [ Time Frame: on-going ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 5 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2022 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hand Transplant |
Procedure: Hand transplantation
allotransplantation of deceased donor composite tissue (hand and forearm)
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- male or female, 18-55 years of age, with below elbow amputation
- ability to give informed consent
Exclusion Criteria:
- Any condition that precludes serial follow-up.
- Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data.
- 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.
- Current or peak Panel Reactive Antibody (PRA) due to alloantibodies > 20% receiving their first allograft.
- 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
- Active psychiatric and/or substance abuse disorders that would 1) impair the subject's ability to provide informed consent; 2) compromise compliance with transplantation-related medical care, or 3) otherwise significantly threaten the successful completion of this protocol.
Contacts and Locations| Contact: Linda C. Cendales, M.D. | 404-727-0701 | lcendal@emory.edu |
| Contact: Beth Begley, BSN | 404-712-7168 | beth.begley@emoryhealthcare.org |
| United States, Georgia | |
| Veterans Affairs Medical Center | Recruiting |
| Atlanta, Georgia, United States, 30033 | |
| Principal Investigator: Linda C. Cendales, MD | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Linda C. Cendales, MD | |
| Principal Investigator: | Linda C. Cendales, MD | Emory University School of Medicine, VA Medical Center |
More Information
No publications provided
| Responsible Party: | Linda C Cendales, MD, Assistant Professor of Surgery, Emory University |
| ClinicalTrials.gov Identifier: | NCT00778856 History of Changes |
| Other Study ID Numbers: | 00007760 |
| Study First Received: | October 7, 2008 |
| Last Updated: | November 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013