Vascularized Composite Allotransplantation of the Hand

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.

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