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Vascularized Composite Allotransplantation of the Hand (HandCTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Collaborators:
Jewish Hospital and St. Mary's Healthcare
Kleinert, Kutz and Associates
University of Louisville
U.S. Army Medical Research and Materiel Command
United States Department of Defense
Information provided by (Responsible Party):
Christina L. Kaufman PhD, Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT00711373
First received: July 7, 2008
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
This is a clinical trial of unilateral and bilateral hand transplantation. This will be done by the surgical transfer of a hand from a non-living donor to restore function of non-functioning or amputated hand. Recipients must currently take the same type of drugs as a kidney transplant patient to prevent rejection of the hand.

Condition Intervention Phase
Upper Extremity Injuries
Procedure: Allogeneic hand transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vascularized Composite Allotransplantation of the Hand

Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:

Primary Outcome Measures:
  • functioning allograft [ Time Frame: Monthly functional analysis for first three months and then on an annual basis for the life of the graft ] [ Designated as safety issue: No ]
    Subjects will be monitored in Louisville for three months. After that subject will be monitored for function of the allograft on an annual basis or as clinical course indicates. We are requesting that subjects allow function to be evaluated on an annual basis for the life of the graft.


Secondary Outcome Measures:
  • document and manage complications associated with Composite Tissue allotransplantation [ Time Frame: monthly labs for the first year, then bi-monthly for the first five years, or as clincial course indicates ] [ Designated as safety issue: Yes ]
    Transplant recipients will have drug levels drawn weekly and then monthly until target blood levels of immunosuppression are acheived. We will then have blood drawn monthly and then quarterly as time progresses. We are requesting that subjects allow us to follow them for the life of the graft.


Estimated Enrollment: 20
Study Start Date: June 1998
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unilateral and Bilateral Amputees Procedure: Allogeneic hand transplantation
Surgical reconstruction of part or all of the hands and/or hands and forearm using tissue from a non-living donor

Detailed Description:

At the Christine M. Kleinert Institute in Louisville, Kentucky, we are recruiting patients for a research protocol that is underway for Composite Tissue Allotransplantation of the Hand. This study is not for all upper extremity injuries, but it is a possibility for some.

The Hand Surgeons at Kleinert, Kutz and Associates and the Christine M. Kleinert Institute performed the first hand transplant in the United States. This patient is doing very well, and is now almost 15 years post transplant. We have also transplanted seven other recipients, including a bilateral recipient. For more information visit www.handtransplant.com.

While hand transplantation is a viable option for select upper extremity amputees, there are significant risks that must be understood before a patient can decide whether hand transplantation is the right option for him or her. The major risk is the systemic immunosuppression that all current hand transplant recipients must take.

As part of this clinical trial of hand transplanation we are also offering a sub-study sub study to determine if cells isolated from fat tissue can be used to control the immune response against the graft. This population of cells that will be isolated from fat tissue is called the stromal vascular fraction (SVF) and has been used on an experimental basis in patients who have problems with blood vessels in their legs, with patients who have received a bone marrow transplant, and with patients who have Chron's disease. These trials have also been experimental. To date, there have been no cases where the SVF cells isolated from and used in the same patient have been associated with harmful side effects.

In this optional sub-study SVF isolated from the patient's own fat tissue would be injected into the graft at the time of transplant, or at the time of a rejection episode. We hope that these cells will help the hand and the nerves heal, and help control your immune systems response against the donor hand. However, this is an experimental study and we don't know if this will work or not. After your transplant and the injection of the SVF cells you will be followed and treated the same as any other hand transplant recipient in this clinical trial.

This sub-study is optional. Subjects can choose to not participate in this sub-study and still be able to participate in the hand transplant clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidates may be male or female patients between the ages of 18 and 65 who are missing all or part of a hand and forearm
  • No serious co-existing medical or psycho-social problems
  • Must be HIV negative at the time of transplant
  • Crossmatch is negative between donor and recipient
  • Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours of transplant and agree to use reliable contraception for one year following transplant
  • Subjects must give written informed consent

Exclusion Criteria:

  • Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
  • Alcoholism not currently under control
  • Malignancy
  • Excessive proximal level of amputation: some presence of proximal muscles is required to motor a functioning hand
  • Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue may affect post transplant results
  • History of amputation of less than six months: subject must be allowed to attempt prosthetic use prior to hand transplantation
  • Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
  • Pregnancy
  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: NCT00711373

Contacts
Contact: Tuna Ozyurekoglu, MD 502-561-0352 tozyurekoglu@cmki.org
Contact: Donna Stacy, RN 502-562-0313 dstacy@cmki.org

Locations
United States, Kentucky
Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Donna Stacy, RN    502-562-0313    dstacy@cmki.org   
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Principal Investigator: Chris Jones, MD         
Principal Investigator: Tuna Ozyurekoglu, MD         
Sponsors and Collaborators
Christina L. Kaufman PhD
Jewish Hospital and St. Mary's Healthcare
Kleinert, Kutz and Associates
University of Louisville
U.S. Army Medical Research and Materiel Command
United States Department of Defense
Investigators
Principal Investigator: Chris Jones, MD Jewish Hospital Transplant Center
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute
  More Information

Additional Information:
Responsible Party: Christina L. Kaufman PhD, Exec. Director, Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT00711373     History of Changes
Other Study ID Numbers: 192.98  DoD-OAR A-14022.5 
Study First Received: July 7, 2008
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
VCA
composite tissue allotransplantation
amputation
Hand

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 23, 2016