Vascularized Composite Allotransplantation of the Hand and Upper Extremity (Hand Transplant)

Hand transplantation is the surgical attachment of a hand and sometimes an arm from an organ
donor to a person who has previously suffered an amputation. It is similar to other organ
transplants, such as a heart, liver, or kidney, in that the tissue comes from a deceased
donor and therefore requires lifelong medications to prevent rejection. Hand transplantation
also requires extensive hand rehabilitation to regain function of the transplanted limb.

The primary focus of the study is to perform hand transplantation using a steroid-sparing
immunosuppression regimen, to closely follow outcomes for at least 2 years after the
transplant, and to utilize new methods for immune system and functional recovery. The number
and severity of side effects and the treatment provided will be analyzed in relation to the
standard immunosuppressive drugs used. Functional and clinical outcomes will be correlated
with data on quality of life.

After consultation with the study team and signing of the study consent forms, patients will
undergo a thorough screening phase, including imaging, laboratory tests, age-appropriate
screening, psychosocial evaluations, physical and occupational therapy (OT) screening, and
tissue typing. Patients will then be selected by a formal patient selection committee
meeting, based on results of screening procedures.

If found to be a good candidate for hand transplantation, the patient will be listed with the
United Network for Organ Sharing (UNOS) to wait for a compatible donor. Organ donors from the
surrounding region will be screened for compatibility in regards to blood type and tissue
type, as well as hand size, skin color, tone, and hair patterns. Once a matching donor is
located, the hand transplant team and participant will be notified.

After surgery the patient will stay in the intensive care unit for 1-3 days and then move to
a regular hospital room where they will stay for 1-2 weeks. Physical therapy will begin
within 2-3 days after surgery, and transplant staff will give daily information on the
anti-rejection medications. After discharge from the hospital, the patient will stay locally
for 3-6 months to monitor for signs of rejection and for extensive hand rehabilitation.
Housing will be provided during this period by the hospital. Functional, psychological and
immunological outcomes will then be closely followed for the life of the allograft.

Inclusion Criteria:

- Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper
limb loss from trauma or other causes desiring limb transplantation

- Below-shoulder amputation

- Male or female and of any race, color or ethnicity

- Aged 18-69 years

- Willing and able to understand and sign informed consent form

- No co-existing medical condition which, in the opinion of the study team, would place
them at high risk for the surgical procedure, immunosuppression protocol, or
functional results

- No co-existing psychosocial problems (i.e., alcoholism, drug abuse, lack of social
support) or issue identified during psychosocial battery of testing

- Negative for malignancy for past 5 years

- Negative for hepatitis C virus or HIV at transplant

- Negative crossmatch with donor

- If female of child-bearing potential, negative serum pregnancy test

- If female of child-bearing potential, consent to use reliable contraception for at
least one year following transplantation

- Willing and able to sign consents for tissue studies

- Willing to comply with Intermediate System (IS) and hand therapy protocols

Exclusion Criteria:

- Conditions that, in the opinion of the investigators, would place patient at
unacceptably high risk for the surgical procedure, immunosuppression protocol, or
functional results

- Sensitized recipients with high levels (>70%) of panel-reactive human leukocyte
antigen (HLA) antibodies

- Conditions that may impact the success of the surgical procedure or increase the risk
of postoperative complications including inherited coagulopathies like Hemophilia,
Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias,
Sickle Cell disease, etc.

- Mixed connective tissue diseases and collagen diseases that may result in poor wound
healing after surgery.