Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

General Information

Summary The main objective of the study is evaluation of the safety and tolerability of OpRegen - human embryonic stem cell-derived retinal pigment epithelial (RPE)cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.
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 in ophthalmic Balanced Salt Solution Plus (BSS Plus). 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.
Clinical trials phase Phases 1/2
Start date (estimated) 2015-04-01
End date (estimated) 2019-12-31
Clinical feature
Label atrophic macular degeneration
Link http://www.ebi.ac.uk/efo/EFO_1001492
Description Dry AMD is most common type of macular degeneration and affects 90% of the people who have the condition. In the dry form, there is a breakdown or thinning of the layer of retinal pigment epithelial cells (RPE) in the macula. No medical or surgical treatment is available for this condition.
Publications

Administrative Information

NCT Number NCT02286089
Other study identifiers
Name CCN_CT02
Source weblink http://clinicaltrials.gov/ct2/show/NCT02286089
Regulatory body approval
Country
Public contact
Email maria@cellcure.co.il
Public email maria@cellcure.co.il
First name Maria
Last name Gurevich
Phone +972-733263657
City Jerusalem
Country
Israel
Sponsors BioTime Inc.
Collaborators

Cell Line

Stem cell lines obtained from

Recruitment

Recruitment Status Recruiting
Estimated number of participants 24