drugset / Trial / NCT03963154
Interventional Study of Implantation of hESC-derived RPE in Patients With RP Due to Monogenic Mutation
NaSequentialOpen-labelTreatment
Summary
Phase I/II open-label, safety, tolerability and preliminary efficacy study of implantation into one eye of hESC-derived RPE (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)) in patients with retinitis pigmentosa due to monogenic mutation. Study non randomized single group assignment consisting in 2 sequential cohorts of patients: * First cohort of 2 patients with very advanced loss of visual acuity (legally blind) * Second cohort of 10 patients with less advanced loss of visual acuity:
Timeline
- Start
- 2019-08-19
- Primary completion
- 2023-06-22
- Completion
- 2026-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ISTEM-01 | Cell therapy | — | Other |