deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT02577861

Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency (HOLOCORE)

Multinational, Multicentre, Prospective, Open-label, Uncontrolled Clinical Trial to Assess the Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency Due to Ocular Burns (HOLOCORE)

Sponsor: Holostem s.r.l.

Updated 12 times since 2017 Last updated: Mar 31, 2022 Started: Oct 31, 2015 Primary completion: Dec 31, 2020 Completion: Mar 11, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Limbal Stem Cells Deficiency and is currently completed. Holostem s.r.l. leads this study, which shows 12 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotRecruiting~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshotRecruiting~Dec 2018 – ~Jan 2020 · 13 months · monthly snapshotRecruiting~Jan 2020 – ~Sep 2020 · 8 months · monthly snapshotRecruiting~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotActive Not Recruiting~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshotActive Not Recruiting~Sep 2021 – ~May 2022 · 8 months · monthly snapshotActive Not Recruiting~May 2022 – ~Jul 2024 · 26 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshotCompleted~Mar 2025 – present · 16 months · monthly snapshotCompleted

Change History

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

    Completed PHASE4

  2. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. May 2022 — Jul 2024 [monthly]

    Completed PHASE4

    Status: Active Not RecruitingCompleted

  5. Sep 2021 — May 2022 [monthly]

    Active Not Recruiting PHASE4

Show 7 earlier versions
  1. Mar 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE4

  2. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE4

  3. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE4

    Status: RecruitingActive Not Recruiting

  4. Jan 2020 — Sep 2020 [monthly]

    Recruiting PHASE4

  5. Dec 2018 — Jan 2020 [monthly]

    Recruiting PHASE4

  6. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE4

  7. Jan 2017 — Jun 2018 [monthly]

    Recruiting PHASE4

    First recorded

Oct 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Holostem s.r.l.
Data source: Holostem s.r.l.

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

Study Locations