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Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure

NCT05093166 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-11-12

No results posted yet for this study

Summary

The purpose of this trial is to assess the safety and efficacy of Holour in patients suffering from hypospadias treatment failure. Holour is intended for urethral replacement and is made from ex vivo expanded autologous oral mucosal cells including stem cells.

Conditions

  • Hypospadias

Interventions

DRUG

"Ex vivo" expanded autologous human oral epithelium containing stem cells

The treatment includes a single administration of investigational product through a dedicated surgical procedure of penis wound bed preparation, epithelial surface adaption and product application followed by urethra tubularization and penis reconstruction.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • Holostem s.r.l.

    lead INDUSTRY

Principal Investigators

  • Graziella Pellegrini, Professor · Holostem s.r.l.

  • Gianantonio Manzoni, MD · Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-26
Primary Completion
2022-12-12
Completion
2022-12-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093166 on ClinicalTrials.gov