USC-Exos in Corpus Spongiosum Reconstruction for Hypospadias

Hypospadias is one of the common congenital malformation disorders in male children, with a ratio of about 1 to 300 in newborn boys. Proximal hypospadias, due to the underdeveloped corpus spongiosum, has a high incidence of postoperative complications (e.g., urethral fistula, stricture, recurrence of penile curvature), exceeding 50%. Traditional surgeries focus on urethral tubularization but fail to restore the corpus spongiosum, leading to long-term micturition and sexual dysfunction.

Recent studies have shown that stem cell exosomes promote angiogenesis and tissue repair through paracrine mechanisms. Urine-derived stem cells (USC) have the advantages of non-invasive acquisition and high proliferative capacity, and the investigator's previous study found that the USCs secreted exosomes (USC-Exos) promoted the regeneration of cavernous sinusoids in an animal model. In this study, the investigators applied autologous USC-Exos for the first time to pediatric hypospadias surgery to evaluate its clinical value in corpus spongiosum reconstruction.

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Children's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

46, XY karyotype
proximal hypospadias
treated with Byar staged surgery
informed consent from guardians.

Exclusion criteria

patients with sexual development disorders
those undergoing one-stage repair
patients or guardians refusing participation
those lost to follow-up

Treatment and study plan

Exsome

Procedure

200 ml of urine was collected by aseptic catheterization, after which it was centrifuged and expanded to the P6 generation using a gelatin-coated culture plate. Exosome extraction: USC-Exos was isolated via tangential flow filtration combined with ultrafiltration. Quality control was performed via nano-flow cytometry (particle size 72.27±21.90 nm), transmission electron microscopy (double-membrane structure), and Western blot (positive for CD9/CD63/TSG101).

First stage, the dorsal penile foreskin flap was transferred to the ventral side to reconstruct the urethral plate (Byar Stage Ⅰ). In the exosome group, USC-Exos (1-3×10^10^/ml) were applied topically.

Second-stage, urethral tubularization after 6-9 months, urethral plate tissues were taken for HE, CD31, α-SMA and VEGF immunohistochemical analysis during the surgery.

Placebo

Procedure

First stage, the dorsal penile foreskin flap was transferred to the ventral side to reconstruct the urethral plate (Byar Stage Ⅰ). In the control group, sodium hyaluronate was used.

Second-stage, urethral tubularization after 6-9 months, urethral plate tissues were taken for HE, CD31, α-SMA and VEGF immunohistochemical analysis during the surgery.

Primary outcomes

100% participants treated with the staged surgery

Time frame: From enrollment to the 6 months after the second stage surgery

82 participants were average divided into Exosome and Control group. All the participants were treated with the Byar's staged surgery(including I and II stage).

Sponsors and collaborators

Lead sponsor

Shanghai Children's Hospital

Other

Registry information

Official study title

A Study on the Value of Autologous Exosomes Secreted by Urine-derived Stem Cell (USC-Exos) in Corpus Spongiosum Reconstruction for Hypospadias

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Mar 27, 2026
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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