4 terminated, 2 completed. 4 Phase 2, 3 Phase 1, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Terminated 4 |
| Phase 1 | 3 | Terminated 3 |
| Phase 3 | 1 | Terminated 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 Transplantation - Junctional Epidermolysis Bullosa Non-Herlitz Type | Phase 2 / Phase 3 | Terminated | Holostem s.r.l. | 2 | 2022-07-15 | 2025-02-19 |
| Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure "Ex vivo" expanded autologous human oral epithelium containing stem cells - Hypospadias | Phase 1 / Phase 2 | Terminated | Holostem s.r.l. | 1 | 2021-11-26 | 2024-11-12 |
| Clinical Trial to Assess Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified in Patients With JEB (HOLOGENE17) Transplantation surgery of genetically corrected cultured epidermal autograft (ATMP) - Junctional Epidermolysis Bullosa | Phase 1 / Phase 2 | Terminated | Holostem s.r.l. | 1 | 2018-03-19 | 2022-03-07 |
| Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns Ophthalmologic examinations, Digital pictures, QoL Questionnaires - Limbal Stem Cell Deficiency Due to Ocular Burn | Completed | Holostem s.r.l. | 47 | 2017-12-13 | 2023-05-26 | |
| Clinical Trial to Assess Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified in Patients With RDEB. Genetically corrected cultured epidermal autograft (ATMP) - Recessive Dystrophic Epidermolysis Bullosa | Phase 1 / Phase 2 | Terminated | Holostem s.r.l. | 3 | 2017-01-30 | 2022-02-16 |
| Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency Biopsy from donor eye, Implant of Holoclar, Ophtalmologic examination - Limbal Stem Cells Deficiency | Phase 4 | Completed | Holostem s.r.l. | 70 | 2015-10-01 | 2022-04-01 |
Epidermolysis Bullosa Dystrophica (1) · Epidermolysis Bullosa, Junctional (1) · Epidermolysis Bullosa, Junctional, Non-Herlitz Type (1) · Hypospadias (1)
cyclic adenosine-5'-trimetaphosphate (2) · Restraint, Physical (1) · Surveys and Questionnaires (1) · Transplantation (1)
Italy (4) · Austria (2) · France (1)
Graziella Pellegrini, Professor (3) · Johann W. Bauer, MD (2) · Michele De Luca, MD/Professor (2) · Paolo Rama, MD (2) · Cristina Magnoni, MD, Surgeon (1) · Gianantonio Manzoni, MD (1)
2014 (1), 2015 (1)