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Penile Allotransplantation for Traumatic Injury

This study is looking at penile allotransplantation (a penis transplant) for men who have lost their penis due to traumatic injury. Researchers want to see if this procedure is possible and how well it works, including its effect on quality of life. The study uses a special treatment plan with Monoclonal Antibody (Humanized Anti-CD52) and Tacrolimus to help prevent the body from rejecting the new penis. Success will be measured by how long the transplanted penis survives, up to five years after the surgery. Men between 18 and 69 years old can join. The current recruitment status for this study is unclear, and it aims to enroll 60 participants.

Study design
This is an interventional study with a planned enrollment of 60 male participants aged 18 to 69 years.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess allograft (transplanted organ) survival from the time of transplantation up to five years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02395497

Human Penile Allotransplantation

Recruiting
PHASE2Ages 18–69InterventionalTreatment
Johns Hopkins University
~60 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Monoclonal Antibody (Humanized Anti-CD52)TacrolimusPenile Allotransplantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Allograft Survival
Measured over Transplantation through end of study period (up to 5 years)

Conditions

Amputation
Wounds and Injuries
Amputation, Traumatic
Urologic Surgical Procedures, Male
Amputation, Traumatic/Surgery
Penis/Transplantation
Penis/Surgery
Penis/Injuries
Congenital Anomaly, Male Genitalia

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Ambiguous GenitaliaMicropenisPenile CarcinomaPenile Injury

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Richard Redett, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Jane Littleton, CRNP, MSN
[email protected]
410-955-6875
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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.

Exclusion

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.
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.
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.

What this trial measures

  • Allograft SurvivalTransplantation through end of study period (up to 5 years)

    use an immunomodulatory protocol to reduce immunosuppression. Post-operative allograft survival will be assessed by various clinical measures including: physical assessments, imaging assessments (ultrasound, CT angiography, magnetic resonance (MR) Neurography and MRI) immune monitoring (screen patient sera for donor specific antibodies), hematologic and metabolic tests, viral tests, chimerism tests, and skin biopsies