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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00778856 |
Organ transplantation has become the treatment of choice for most patients suffering end stage diseases of the kidney, pancreas, liver, heart or lung. However, patients that suffer from unreconstructable tissue loss have not been able to benefit from transplantation therapies both for immunological and technical reasons. This is particularly true for complex innervated tissues such as the hand. Patients with limb loss have thus been required to adapt to their deficiency and utilize prostheses that, while helpful, remain insensate, limited in functionality, and cosmetically sub-optimal.
If transplant therapies could be successfully applied in the setting of limb amputation, it would greatly improve the functionality and quality of life for amputees.
Composite Tissue Allotransplantation (CTA) is the term used to describe transplantation of multiple tissues (skin, muscle, bone, cartilage, nerve, tendon, vessel) as a functional unit. Several recent advances in clinical organ transplant immunosuppression and experimental limb CTA have now made it feasible to consider clinical CTA for the functional restoration of patients with loss of one or both hands.
This protocol facilitates the development of limb CTA 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.
Five 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 prophylaxis for opportunistic infections and an immunosuppressive regimen based on induction therapy followed by chronic immunosuppression to include tacrolimus and mycophenolate mofetil. Rejections will be treated in keeping with experience from the solid organ transplant experience. Graft failure will be treated with allograft amputation.
Condition | Intervention |
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Amputation Transplantation |
Procedure: Hand transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Hand Transplantation for the Reconstruction of Below the Elbow Amputations |
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 |
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Hand Transplant: Experimental |
Procedure: Hand transplantation
allotransplantation of deceased donor composite tissue (hand and forearm)
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda C. Cendales, M.D. | 404-712-1737 | 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 | Not yet 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 |
Responsible Party: | Emory University School of Medicine and Veterans Affairs Medical Center ( Linda Cendales, MD ) |
Study ID Numbers: | 00007760 |
Study First Received: | October 7, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00778856 |
Health Authority: | United States: Institutional Review Board |