NCT07495176

USC-Exos in Corpus Spongiosum Reconstruction for Hypospadias

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Shanghai Children's Hospital · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypospadias

Interventions

Type	Name	Description
PROCEDURE	Exsome	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.
PROCEDURE	Placebo	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China