Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Age - Related Macular Degeneration
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
OpRegen® is a cell-based product composed of retinal pigment epithelial (RPE) cells, derived from human embryonic stem cells (hESC) and administered as a cell suspension either in ophthalmic Balanced Salt Solution Plus (BSS Plus) or in CryoStor® 5 (Thaw-and-Inject, TAI). This is a Phase I/IIa, dose-...
OpRegen® is a cell-based product composed of retinal pigment epithelial (RPE) cells, derived from human embryonic stem cells (hESC) and administered as a cell suspension either in ophthalmic Balanced Salt Solution Plus (BSS Plus) or in CryoStor® 5 (Thaw-and-Inject, TAI). This is a Phase I/IIa, dose-escalation, evaluating safety and tolerability of OpRegen transplantation to patients with progressive dry-AMD. The study includes also initial exploration of efficacy. A total of approximately 24 subjects will be enrolled. The subjects should be 50 years of age and older, with non-neovascular (dry) AMD, who have funduscopic findings of GA in the macula, with absence of additional concomitant ocular disorders. The subjects will be divided into four cohorts, according to their best corrected visual acuity (BCVA) and administered OpRegen dose.
Tracking Information
- NCT #
- NCT02286089
- Collaborators
- CellCure Neurosciences Ltd.
- Investigators
- Principal Investigator: Tareq Jaouni, MD Hadassah Ein Kerem University Hospital, Israel Principal Investigator: Rita Ehrlich, MD Rabin Medical Center, Israel Principal Investigator: Adiel Barak, MD, Prof. Tel Aviv Souraski Medical Center, Israel Principal Investigator: Richard McDonald, MD West Coast Retina Medical Group, Inc, USA Principal Investigator: David Boyer, MD Retina Vitreous Associates Medical Group, USA Principal Investigator: Diana Do, MD, Prof. Byers Eye Institute, Stanford, USA Principal Investigator: David Telander, MD Retinal Consultants Medical Group, USA Principal Investigator: Christopher Riemann, MD Cincinnati Eye Institute Principal Investigator: Allen Ho Wills Eye Hospital Retina Service
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