Clinical Trial: Vascularized Composite Allotransplantation of the Hand

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Vascularized Composite Allotransplantation of the Hand

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Christina L. Kaufman PhD

Current Primary Outcome: functioning allograft [ Time Frame: Monthly functional analysis for first three months and then on an annual basis for the life of the graft ]

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.


Original Primary Outcome: functioning allograft [ Time Frame: weekly, monthly for the first year, at 18 months and then annually ]

Current Secondary Outcome: 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 ]

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.


Original Secondary Outcome: document and manage complications associated with Composite Tissue allotransplantation [ Time Frame: montly as long as the subject has the transplant ]

Information By: Christine M. Kleinert Institute for Hand and Microsurgery

Dates:
Date Received: July 7, 2008
Date Started: June 1998
Date Completion: June 2017
Last Updated: April 14, 2016
Last Verified: April 2016