Penis transplants could restore form and function for wounded warriors
NCT ID NCT02395497
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ambiguous male genitalia are added.
By submitting, you agree to our Terms of use
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
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Johns Hopkins University School of Medicine
RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can we predict prosthetic success? a study seeks answers
- Can bionic limbs feel real? a trial tests touch feedback for amputees
- Can a common anesthetic dampen phantom limb pain?
- A new physical therapy twist could rebuild knees after dislocation
- Can tiny electrodes give amputees a better grip on bionic limbs?
- Can a Two-Drug punch erase penile cancer before surgery?