- Recent (≥6 months) or remote (i.e., several decades) unilateral or bilateral upper
limb loss (below the shoulder) desiring limb transplantation.
- Below-shoulder amputation.
- Male or female and of any race, color or ethnicity.
- Aged 18-69 years.
- Completes the protocol informed consent form.
- No co-existing medical condition which, in the opinion of the study team, could
affect the immunomodulatory protocol, surgical procedure, or functional results (see
Donor and Recipient Exclusion Criteria below. If the condition is amenable to
treatment, the study team must agree that said condition should not significantly
enhance the surgical risks of upper extremity transplantation.)
- No co-existing psycho-social problems (i.e., alcoholism, drug abuse).
- Negative for malignancy for past 5 years.
- Negative for 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.
- Consents to bone marrow infusion as part of the treatment regime.
- USA citizen or equivalent.
- Patient agrees to comply with the protocol and states a dedication to the
immunomodulatory treatment regime.
- Positive for any of the following conditions:
- Untreated sepsis.
- HIV (active or seropositive).
- Active tuberculosis.
- Hepatitis B or C.
- Viral encephalitis.
- Malignancy (within past 5 years).
- Current/recent (within 3 months of donation/screening consent) IV drug abuse.
- Paralysis of ischemic or traumatic origin.
- Inherited peripheral neuropathy.
- Infectious, post infectious, or inflammatory (axonal or demyelinating)
- Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent
- Mixed connective tissue disease.
- Severe deforming rheumatoid or osteoarthritis in the limb.
- Conditions that, in the opinion of the study team, may impact the immunomodulatory
protocol potentially exposing the recipient to an unacceptable risk under
- Sensitized recipients with high levels (50%) of panel-reactive 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 can result in poor wound
healing after surgery.
- Conditions that may impact functional outcomes including Lipopolysaccharidosis and
amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like
- Patients considered unsuitable per the consulted Psychiatrists appraisal.