Urine-derived stem cell therapy shows promise for reducing surgery complications in boys with hypospadias
NCT ID NCT07495176
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether stem cell exosomes from a boy's own urine could improve healing after surgery for hypospadias, a common birth defect where the urethra opening is not at the tip of the penis. 82 boys with severe hypospadias were split into two groups: one received standard surgery plus the exosome treatment, the other had surgery alone. The goal was to see if the exosomes help rebuild the missing spongy tissue and lower the risk of complications like fistulas or narrowing.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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82 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Children's Hospital
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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