Penile allotransplantation for men with severe penile injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the feasibility and effectiveness of penile allotransplantation in men who have lost their penis due to traumatic injuries or cancer. The study will utilize an immunomodulatory protocol to minimize the need for immunosuppression, which is crucial for transplant success. Participants will undergo a thorough assessment of their quality of life before and after the procedure to determine the impact of the transplant on their overall well-being. The trial includes both Wounded Warriors and civilians, focusing on those with significant penile loss.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins University School of Medicine
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Richard Redett, MD — Johns Hopkins University
• Study coordinator: Jane Littleton, CRNP, MSN
• Email: jlittl38@jhmi.edu
• Phone: 410-955-6875

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.