Penis transplants could restore form and function for wounded warriors

NCT ID NCT02395497

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study investigates penile transplantation as a way to replace a severely damaged or missing penis with a donor organ, aiming to restore appearance, sensation, and sexual function. It includes men aged 18-69 who have lost their penis due to trauma, surgery, or birth defects. The approach uses a special immune-suppressing drug regimen to reduce the risk of rejection and the need for long-term medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a combination of monoclonal antibody (humanized anti-CD52), tacrolimus, and penile allotransplantation
What this could lead to
If successful, this could offer a way to restore natural-looking and functional penises for men with severe injuries or congenital defects, improving their quality of life.
What could go wrong
This is an early-stage trial with only 60 participants, and the procedure carries risks of rejection, infection, and side effects from lifelong immunosuppression. It may not work for everyone.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2014

Expected to finish

Jun 2039

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Johns Hopkins University School of Medicine

    RECRUITING

    Baltimore, Maryland, 21287, United States

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