Allogeneic Hand Transplantation Composite Tissue Allotransplantation (HandCTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 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
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: January 30, 2013
Last verified: January 2013
  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
Amputation
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: Composite Tissue Allotransplantation of the Hand

Resource links provided by NLM:


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: 10
Study Start Date: June 1998
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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 more than 12 years post transplant. We have also transplanted five 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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: Joseph E Kutz, MD 502-561-4244 jkutz@cmki.org
Contact: Brenda Blair, RN 502-562-0313 bblair@cmki.org

Locations
United States, Kentucky
Kleinert Kutz and Associates/Jewish Hospital and St. Mary's Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Brenda Blair, RN    502-562-0313    bblair@cmki.org   
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Principal Investigator: Michael Marvin, MD         
Principal Investigator: Joseph E Kutz, 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
Investigators
Principal Investigator: Michael Marvin, MD Jewish Hospital Transplant Center
Principal Investigator: Joseph E Kutz, MD Christine M. Kleinert Institute
  More Information

Additional Information:
No publications provided

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: January 30, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014