Human Upper Extremity (Hand and Forearm) Allotransplantation

This is an interventional treatment trial for Amputation, Traumatic focused on measuring Amputation, upper limb, composite tissue, immunosuppression Read More

Donor Selection Criteria

Brain dead donors who have met the criteria for Determination of Death will be selected by the hand transplant team in conjunction with the CORE (Center for Organ Recovery and Education), the organ procurement agency (OPO) for Pittsburgh and covers Pennsylvania, New York and West Virginia. The mandatory requirements are family consent for limb donation, stable donor (does not require excessive vasopressors to maintain blood pressure), age between 18 to 55 years, limb matched for size with recipient, same blood type as recipient, negative cross-match, and importantly accurately matched for gender, skin tone and race (may be relative requirement depending on recipient consent).

Recipient Selection Criteria

Recipients will be selected from a population of subjects with upper limb loss. Recipients may be male or female and of any race, color or ethnicity.

Inclusion Criteria:

1. Age (>18 years <60 years): Recipients <18 years of age are excluded due to limitations of giving full informed consent and the potentially increased risk of lymphoproliferative disorder in a younger population. Once hand transplantation and in particular the strategy for minimizing immunosuppression has proven to be efficacious and safe, the restrictions with regard to recipient age may be relaxed.
2. No serious co-existing medical (coronary artery disease, diabetes) or psycho-social problems (including alcoholism, drug abuse).
3. Must be negative for malignancy (for 10 years) or HIV (at transplant).
4. Negative crossmatch with donor.
5. Negative pregnancy test in female recipient of child bearing potential and consent to use reliable contraception for at least one year following transplantation.
6. Consent to cell collection, storage, and bone marrow infusion as part of the treatment regime.
7. Amputation may be recent (acute injury) or remote (patient may have undergone rehabilitation with prostheses).

Exclusion Criteria:

1. Conditions that may impact the immunomodulatory protocol: These include diseases like HIV or malignancy that could expose the recipient to an unacceptable risk under immunosuppressive treatment. Sensitized recipients with high level of preformed antibodies are also at risk.
2. Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications: These include inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thallassemias, Sickle Cell disease etc. Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery,
3. Conditions that may impact functional outcomes: Lipopolysaccharidoses and amyloidosis are few of the conditions that may impact nerve regeneration and impair outcomes. Also, rare disorders of bone healing like osteopetrosis may also be causes for exclusion.