Vascularized Composite Allotransplantation for Multiple Extremity Amputations

Limb transplantation surgery, the transfer of the limb(s) from a deceased human donor to a
patient with amputation of one or more limbss, is an experimental reconstructive procedure
that has the potential to significantly improve the lives of amputees.

Limb transplantation is similar to face transplantation in that the tissues transplanted
include skin, tendons, muscles, ligaments, bones and blood vessels. The transplant team at
Brigham and Women's Hospital includes a wide variety of medical and surgical specialties. The
team hopes to build upon the success of their first face transplantation to provide amputee
patients with the significant benefits of limb transplantation.

Toward this goal, BWH is actively seeking qualified candidates for the limb transplant
research study. We will be studying a small group of people to learn more about:

- How to advance the science of limb transplantation

- How to support and limit transplant rejection issues

- How people do after limb transplantation

We describe limb transplant surgery as a life-giving procedure because it has the potential
to dramatically improve, that is to restore, both a patient's mental and physical health and
his/her ability to function and integrate in society. However, as with any other type of
organ transplantation, this improvement will require the patient to make a lifetime
commitment to taking medications that suppress the body's immune system.

Conventional reconstruction methods are always considered first, but they may provide less
than optimal results for certain patients. There are many sophisticated prostheses that
satisfactorily replace the basic function of a missing limb. However, replacing limbs (in
whole or in part) with prosthetics remains suboptimal in that prostheses do not provide
sensation and do not have a natural appearance. Limbtransplant surgery, however, has the
potential to deliver these desired functional and aesthetic benefits. Functionally, limb
transplant surgery can provide a patient with new limbs that, after extensive rehabilitation,
allow him/her to perform daily activities and, in most cases, return to work. Furthermore,
the ability to restore a near-normal aesthetic appearance of the limb(s) can lead to
tremendous psychological benefits, including elevated confidence and mood.

From the time we begin our search for a qualified limb transplant recipient to the continuing
care we provide following surgery, a significant amount of time, expertise and attentiveness
is contributed toward making the procedure a progressive success. Limb transplant candidates
go through an extensive screening process that is likely to last several months. This
screening includes a psychiatric and social support evaluation and a series of imaging tests
to help determine a patient's physical and mental readiness for the procedure. If, upon
completion of the screening process, it is determined that a patient is a suitable candidate,
we will place the patient on a transplant waiting list. We will then begin working with the
New England Organ Bank (NEOB) team to find a donor who matches the recipient's tissue
requirements - for example similar age and correct blood type. This search could take many
months, and, if a suitable donor is not found within one year, we will speak with the patient
to determine whether he/she is willing to continue waiting.

Inclusion Criteria:

- Age between 18 and 60 years.

- Single dominant hand or multiple limb amputation.

- Time elapsed since amputation more than 6 months but less than 15 years.

- Patient has tried prosthesis without success.

- Level of amputation anywhere from the wrist (or ankle) joint to just below the
shoulder (or hip) joint, which should be functional.

- Signed written informed consent.

- Willing to complete psychological and social evaluations.

- Willing to take immunosuppressants - drugs that help prevent rejection of the
transplant - for life.

- Willing to comply with extensive post-transplant rehabilitation for a minimum of two
years.

- Willing to return for follow-up visits as determined by the treating physician.

- Willing to receive standard vaccinations prior to the transplant, such as influenza
and hepatitis B.

Exclusion Criteria:

- Single, non-dominant hand amputees.

- Active malignancy.

- High risk of return of malignancy.

- History of persistent non-compliance.

- Findings of psychological evaluation that indicate inability to comply with
physician's orders or mental instability.

- Any diagnosis that puts the subject at risk from limb transplant surgery or life-long
immune suppression.

- Inability to ensure adequate follow-up of post-transplant care and immune suppression.