Allogeneic Hand Transplantation Composite Tissue Allotransplantation - Full Text View

Allogeneic Hand Transplantation Composite Tissue Allotransplantation (HandCTA)

This study is currently recruiting participants.

Verified by Christine M. Kleinert Institute for Hand and Microsurgery, July 2008

First Received: July 7, 2008 Last Updated: July 9, 2008 History of Changes

Sponsors and Collaborators:	Christine M. Kleinert Institute for Hand and Microsurgery Jewish Hospital and St. Mary's Healthcare Kleinert, Kutz and Associates University of Louisville U.S. Army Medical Research and Materiel Command Department of Defense
Information provided by:	Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:	NCT00711373

Purpose

This is a clinical trial of 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 II

MedlinePlus related topics: Arm Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Composite Tissue 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: weekly, monthly for the first year, at 18 months and then annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

document and manage complications associated with Composite Tissue allotransplantation [ Time Frame: montly as long as the subject has the transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	June 1998
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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 have performed the only three hand transplants in the US out of a total of 38 that have been performed worldwide. All three of our patients are doing well. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711373

Contacts

Contact: Warren C Breidenbach, MD	502-561-4286	wbreidenbach@kleinertkutz.com
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: Warren C Breidenbach, MD 502-561-4286 wbreidenbach@kleinertkutz.com
Contact: Brenda Blair, RN 502-562-0313 bblair@cmki.org
Principal Investigator: Warren C Breidenbach, MD

Sponsors and Collaborators

Christine M. Kleinert Institute for Hand and Microsurgery

Jewish Hospital and St. Mary's Healthcare

Kleinert, Kutz and Associates

University of Louisville

U.S. Army Medical Research and Materiel Command

Department of Defense

Investigators

Principal Investigator:

Warren C Breidenbach, MD

Kleinert, Kutz and Associates

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kleinert, Kutz and Associates ( Warren C. Breidenbach )
Study ID Numbers:	192.98, DoD-OAR A-14022.5
Study First Received:	July 7, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00711373 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:

CTA
composite tissue allotransplantation
amputation
Hand

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

ClinicalTrials.gov processed this record on May 07, 2009