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Study identifier: NCT02395497 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Human Penile Allotransplantation

Condition: Amputation · Wounds and Injuries · Amputation, Traumatic  ·  Sponsor: Johns Hopkins University

PhasePhase 2/Phase 3
Planned participants60
Who can joinMale, 18 Years to 69 Years
Healthy volunteersNo

About this study

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 immunomodulat…

This description comes directly from the study's public registry record.

Talk to the study team

Jane Littleton, CRNP, MSN  ·  410-955-6875  ·  jlittl38@jhmi.edu

TBD TBD  ·  443-287-7848

Always discuss trial participation with your own doctor first.

Locations (1)

Johns Hopkins University School of MedicineBaltimore, Maryland, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT02395497