Human Penile Allotransplantation

Launched by JOHNS HOPKINS UNIVERSITY · Mar 17, 2015

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical option called penile allotransplantation, which aims to help men who have lost a significant portion of their penis due to injuries or medical conditions. Unlike traditional surgical methods that can only partially recreate the appearance and function of the penis, this trial seeks to see if transplanting a donor penis can provide better results in terms of appearance, sensation, and erectile function. The goal is to improve the quality of life for individuals affected by these traumatic injuries.

To participate in this study, men aged 18 to 69 with a severe loss of the penis (at least 75%) from injury, cancer, or congenital issues may be eligible. Participants should not have serious medical or psychological conditions that could complicate the surgery or recovery. If accepted, they can expect to undergo a detailed evaluation and be part of a treatment plan that includes careful monitoring and support to ensure the best possible outcomes. This trial is currently recruiting participants, and it represents a hopeful advancement in restoring functionality and quality of life for those affected by penile injuries.

Gender

MALE

Eligibility criteria

• 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.