USC-Exos in Corpus Spongiosum Reconstruction for Hypospadias

NCT07495176 | Completed

• 1 other identifier: SHDC2020CR3013A
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hypospadias; corpus spongiosum; urethral reconstruction; urine-derived stem cell; exosome

Outcome Measures

Primary Outcomes (1)

• 100% participants treated with the staged 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).

  From enrollment to the 6 months after the second stage surgery

Study Arms (2)

exosome group

EXPERIMENTAL

Children with proximal hypospadias admitted to the Department of Urology of Shanghai Children's Hospital Inclusion criteria: 46, XY karyotype; treated with Byar staged surgery; and informed consent from guardians. Exclusion criteria: patients with sexual development disorders; those undergoing one-stage repair; patients or guardians refusing participation; and those lost to follow-up.

Procedure: Exsome

Control group

PLACEBO COMPARATOR

Use the sodium hyaluronate

Procedure: Placebo

Interventions

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.

exosome group

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.

Control group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Children's Hospital: lead

Study Sites (1)

Shanghai Children's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)