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Clinical study on repairing corpus spongiosum of hypospadias using autologous UDC-Exos

Clinical study on repairing corpus spongiosum of hypospadias using autologous UDC-Exos

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036403
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Interventions

Experimental group:In the first stage of operation, UDC-Exos was smeared on the outer surface of prepuce or oral mucosa, and then the prepuce or oral mucosa was fixed on the ventral surface of penile
Control group:In the first stage of operation, placebo (saline) was smeared on the outer surface of prepuce or oral mucosa, and then the prepuce or oral mucosa was fixed on the ventral surface of peni

Sponsors

Children's Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Children with severe hypospadias who need to undergo staged operation using autologous prepuce or oral mucosa as urethral reconstruction materials, and their guardians should have informed consent.

Exclusion criteria

Exclusion criteria: Patients with DSD (dysplasia of sexual development). Patients with other external genitalia abnormalities.Patients who could complete hypospadias surgery in one stage. Patients' guardians refused to participate in the study.

Design outcomes

Primary

MeasureTime frame
Repair effect of corpus spongiosum defect;

Secondary

MeasureTime frame
Surgical effect and postoperative complications of hypospadias;

Countries

China

Contacts

Public ContactFang Chen

Children's Hospital of Shanghai

doctorchenfang@126.com+86 18916833333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026