deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT05093166

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

Prospective, Open-label, Uncontrolled Pilot Clinical Trial to Assess the Safety and Efficacy of Autologous Cultured Oral Mucosa Grafts for Urethral Reconstruction in Patients Due to Hypospadias Treatment Failure

Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Conditions Hypospadias
Updated 8 times since 2021 Last updated: Nov 11, 2024 Started: Nov 26, 2021 Primary completion: Dec 12, 2022 Completion: Dec 12, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Due to the current re-organization at the Sponsor site

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This PHASE1/PHASE2 trial investigates Hypospadias and is currently terminated or withdrawn. Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico leads this study, which shows 8 recorded versions since 2021 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshotRecruiting~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshotRecruiting~Mar 2022 – ~Apr 2023 · 13 months · monthly snapshotRecruiting~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotSuspended~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotSuspended~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshotSuspended~Dec 2024 – ~Mar 2025 · 3 months · monthly snapshotTerminated~Mar 2025 – present · 16 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Mar 2025 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Dec 2024 — Mar 2025 [monthly]

    Terminated PHASE1/PHASE2

    Status: SuspendedTerminated

  3. Sep 2024 — Dec 2024 [monthly]

    Suspended PHASE1/PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Suspended PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  5. Apr 2023 — Jul 2024 [monthly]

    Suspended PHASE1_PHASE2

    Status: RecruitingSuspended

Show 3 earlier versions
  1. Mar 2022 — Apr 2023 [monthly]

    Recruiting PHASE1_PHASE2

  2. Dec 2021 — Mar 2022 [monthly]

    Recruiting PHASE1_PHASE2

  3. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Holostem s.r.l.
  • University of Modena and Reggio Emilia
Data source: Holostem s.r.l.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations