Human Penile Allotransplantation

Last updated: July 3, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Birth Defects

Holoprosencephaly

Treatment

Penile Allotransplantation

Tacrolimus

Monoclonal Antibody (Humanized Anti-CD52)

Clinical Study ID

NCT02395497
NA_00089306
  • Ages 18-69
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 bloodpressure).

  • 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 theloss of ≥75% of the phallus.

  • Penectomy secondary to penile cancer

  • Penile Cancer Survivors > 5 years

  • Micropenis associated with congenital/birth defect and severely ambiguous malegenitalia

  • Must have completed a clinic appointment with one of the study surgeons to discussall penile reconstructive options.

  • Completes the protocol informed consent form(s).

  • No co-existing medical condition which, in the opinion of the study team, couldaffect the immunomodulatory protocol, surgical procedure, or functional results (Ifthe condition is amenable to treatment, the study team must agree that saidcondition should not significantly enhance the surgical risks of peniletransplantation.).

  • 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 marrowinfusion as part of the treatment regimen.

  • USA citizen or equivalent.

  • Patient agrees to comply with the protocol and states a dedication to theimmunomodulatory treatment regimen.

Exclusion

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 agentexposure).

  • 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 personallyidentifiable tattoo (i.e., donor name) on potential transplant.

Recipient Only Exclusion Criteria:

  • Conditions that, in the opinion of the study team, may impact the immunomodulatoryprotocol potentially exposing the recipient to an unacceptable risk underimmunosuppressive treatment.

  • Sensitized recipients with high levels (50%) of panel-reactive human leukocyteantigen (HLA) antibodies.

  • Conditions that may impact the success of the surgical procedure or increase therisk of postoperative complications including inherited coagulopathies likeHemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias,Thalassemias, Sickle Cell disease, etc.

  • Conditions that may impact functional outcomes including Lipopolysaccharidosis andamyloidosis (may impact nerve regeneration).

  • Patients considered psychologically/psychiatrically unsuitable.

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Penile Allotransplantation
Phase: 2/3
Study Start date:
June 01, 2014
Estimated Completion Date:
June 30, 2039

Study Description

Specific Aims: 1) To assess the feasibility and function of penile allotransplantation in Wounded Warriors and civilians who have lost their penis due to battle or traumatic injury, using an immunomodulatory protocol to reduce immunosuppression; 2) To assess pre-to-post changes in QOL in patients who undergo penile allotransplantation.

Connect with a study center

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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