Recruiting
Phase 2
Phase 3

Penile Allotransplantation

Sponsor:

Johns Hopkins University

Code:

NCT02395497

Conditions

Amputation

Wounds and Injuries

Amputation, Traumatic

Urologic Surgical Procedures, Male

Amputation, Traumatic/Surgery

Eligibility Criteria

Sex: Male

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

Monoclonal Antibody (Humanized Anti-CD52)

Tacrolimus

Penile Allotransplantation

Study Details

Brief summary:

Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction.

The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results.

Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.

Conditions

Amputation

Wounds and Injuries

Amputation, Traumatic

Urologic Surgical Procedures, Male

Amputation, Traumatic/Surgery

Study ID

NCT02395497

Start date

Jun, 2014

Status verified date

Jul, 2026

Completion date

Jun, 2039

Anticipated

Primary completion date

Jun, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 69

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment: Transplantation

Penile transplantation with an immunomodulatory protocol consisting of monoclonal antibody induction therapy of humanized anti CD52 followed by donor bone marrow infusion and tacrolimus monotherapy.

Interventions

Monoclonal Antibody (Humanized Anti-CD52)

Tacrolimus

Penile Allotransplantation

Primary outcome measure

  • Allograft Survival [ Time Frame: Transplantation through end of study period (up to 5 years) ]

Central Contacts and Locations

Central contacts

Jane Littleton, CRNP, MSN

410-955-6875jlittl38@jhmi.edu

TBD TBD

443-287-7848

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Carisa Cooney, MPH,CCRP

443-287-4629ccooney3@jhmi.edu

TBD TBD

443-287-7848

Principal Investigator:

Richard Redett, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Penile Transplant
  • Vascularized Composite Allotransplantation (VCA)
  • Composite Tissue Allotransplantation (CTA)
  • Penis
  • Amputation
  • Immunosuppression
  • Composite Tissue
  • Male
  • Humans
  • Allotransplantation
  • Micropenis
  • Severely Aambiguous Male Genitalia
  • congenital/birth defect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.