Hologene 5 (ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a LAMB3-encoding retroviral vector) / Holostem - LARVOL DELTA

HOLOGENE 5: 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 (clinicaltrials.gov) - P2/3 | N=2 | Terminated | Sponsor: Holostem Terapie Avanzate s.r.l. | Active, not recruiting ➔ Terminated; Development program review and update due to Sponsor re-organization

Trial termination

HOLOGENE 5: 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 (clinicaltrials.gov) - P2/3 | N=2 | Active, not recruiting | Sponsor: Holostem Terapie Avanzate s.r.l. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Dec 2024

Enrollment closed • Trial completion date

HOLOGENE 5: 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 (clinicaltrials.gov) - P2/3 | N=6 | Recruiting | Sponsor: Holostem Terapie Avanzate s.r.l. | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2022 ➔ Jul 2022

Enrollment open • Trial initiation date

HOLOGENE 5: 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 (clinicaltrials.gov) - P2/3 | N=6 | Not yet recruiting | Sponsor: Holostem Terapie Avanzate s.r.l. | Trial completion date: Jun 2023 ➔ Jun 2024 | Initiation date: Nov 2021 ➔ Mar 2022 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial initiation date • Trial primary completion date