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Hand Transplantation for the Reconstruction of Below the Elbow Amputations (CTA-01)
This study is currently recruiting participants.
Verified by Emory University, October 2008
Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00778856
  Purpose

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
Amputation
Transplantation
Procedure: Hand transplantation

U.S. FDA Resources
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

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Hand Transplant: Experimental 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
Criteria

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.
  • Patients with prior transplants
  • Cytomegalovirus and/or Ebstein Barr Virus negative patients
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778856

Contacts
Contact: Linda C. Cendales, M.D. 404-712-1737 lcendal@emory.edu
Contact: Beth Begley, BSN 404-712-7168 beth.begley@emoryhealthcare.org

Locations
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            
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Linda C. Cendales, MD Emory University School of Medicine, VA Medical Center
  More Information

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

ClinicalTrials.gov processed this record on January 14, 2009