Hand Transplantation for the Reconstruction of Below the Elbow Amputations (VCA-01)

This study has suspended participant recruitment.
(Principal Investigator relocated to Duke University. Potentially will resume the study at Duke University)
Sponsor:
Information provided by (Responsible Party):
Linda C Cendales, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00778856
First received: October 7, 2008
Last updated: May 22, 2014
Last verified: May 2014
  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: 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

Resource links provided by NLM:


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 2016 (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)

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 limb device prior to transplantation. We will treat them with immunosuppression known to prevent the rejection of other allografted tissues and designed to minimize their dependence on chronic maintenance immunosuppression. These patients will be studied to determine whether the transplanted limb functions better, worse or the same as a prosthetic hand, and to quantify those differences

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778856

Locations
United States, Georgia
Veterans Affairs Medical Center
Atlanta, Georgia, United States, 30033
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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: IRB00007760
Study First Received: October 7, 2008
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014