Open-label, Pivotal Clinical Trial to Confirm Efficacy and Safety of Autologous Grafts Containing Stem Cells Genetically Modified for Epidermis Restoration in Patients With Junctional Epidermolysis Bullosa (HOLOGENE 5)
Multicentre, Open-label, Uncontrolled, Pivotal Clinical Trial to Confirm the Efficacy and Safety of Autologous Fibrin-cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified for Restoration of Epidermis in Patients With Junctional Epidermolysis Bullosa
Sponsor: Holostem s.r.l.
Terminated
Development program review and update due to Sponsor re-organization
Other terminated trials from Holostem s.r.l.
- Junctional Epidermolysis Bullosa · Phase PHASE1/PHASE2 · Sep 2018
- Recessive Dystrophic Epidermolysis Bullosa · Phase PHASE1/PHASE2 · Aug 2018
More terminations from Holostem s.r.l.
Listed as NCT05111600, this PHASE2/PHASE3 trial focuses on Junctional Epidermolysis Bullosa Non-Herlitz Type and remains terminated or withdrawn. Sponsored by Holostem s.r.l., it has been updated 7 times since 2022, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
7 versions recorded-
Mar 2025 — Present [monthly]
Terminated PHASE2/PHASE3
Status: Active Not Recruiting → Terminated
-
Dec 2024 — Mar 2025 [monthly]
Active Not Recruiting PHASE2/PHASE3
Status: Unknown → Active Not Recruiting
-
Sep 2024 — Dec 2024 [monthly]
Unknown PHASE2/PHASE3
Status: Recruiting → Unknown
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
-
Sep 2022 — Jul 2024 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
▶ Show 2 earlier versions
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Mar 2022 — Sep 2022 [monthly]
Not Yet Recruiting PHASE2_PHASE3
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Dec 2021 — Mar 2022 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Holostem s.r.l.
- IRCCS San Raffaele
- University of Modena and Reggio Emilia
For direct contact, visit the study record on ClinicalTrials.gov .