Human Penile Allotransplantation

Specific Aims: 1) To assess the feasibility and function of penile allotransplantation in Wounded Warriors and civilians who have lost their penis due to battle or traumatic injury, using an immunomodulatory protocol to reduce immunosuppression; 2) To assess pre-to-post changes in QOL in patients who undergo penile allotransplantation.

Donor Inclusion Criteria:

• Males aged 16 - 65 years.
• Brain dead meeting the criteria for Determination of Death.
• Family consent for penile graft donation.
• Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).
• Same blood type as recipient.
• Negative lymphocytotoxic crossmatch.
• Accurately matched for skin tone

Recipient Inclusion Criteria:

• Males of any race, color or ethnicity; aged 18-69 years.
• Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus.
• Penectomy secondary to penile cancer
• Penile Cancer Survivors > 5 years
• Micropenis associated with congenital/birth defect and severely ambiguous male genitalia
• Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options.
• Completes the protocol informed consent form(s).
• No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile 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.
• Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.
• USA citizen or equivalent.
• Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.

Recipient and Donor Exclusion Criteria:

• Untreated sepsis.
• HIV (active or seropositive).
• Active tuberculosis.
• Active Hepatitis B infection.
• Hepatitis C.
• Viral encephalitis.
• Toxoplasmosis.
• 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) neuropathy.
• Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).
• Mixed connective tissue disease.
• Severe deforming rheumatoid or osteoarthritis in the limb.

Donor Only Exclusion Criteria:

• Evidence of active herpes simplex virus-2 (HSV-2) infection.
• Tattoos: non-professional tattoo within the last 6 months, or personally identifiable tattoo (i.e., donor name) on potential transplant.

Recipient Only Exclusion Criteria:

• Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.
• Sensitized recipients with high levels (50%) 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.
• Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).
• Patients considered psychologically/psychiatrically unsuitable.