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โ† Trials
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Human Penile Allotransplantation

RecruitingPhase 2, Phase 3Ages 18 Years - 69 YearsMaleJohns Hopkins University
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In plain words

What the trial is, and whether it could suit you

Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; an

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ6 months) or remote (i.e., several decades) penile injury resulting in the loss of โ‰ฅ75% 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.
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What it tests

  • Monoclonal Antibody (Humanized Anti-CD52)
  • Tacrolimus
  • Penile Allotransplantation
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Where

1 site
Johns Hopkins University School of Medicine
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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