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 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. |
Clinical trials phase |
Phases 1/2 |
Start date (estimated) |
2015-04-01 |
End date (estimated) |
2025-07-01 |
Clinical feature |
Label |
age related macular degeneration |
Link |
http://purl.obolibrary.org/obo/DOID_10871 |
Description |
A degeneration of macula and posterior pole that is characterized by a loss of vision in the center of the visual field (the macula) resulting from damage to the retina and resulting in blurring of the sharp central vision.; OMIM mapping confirmed by DO. [SN]. |
|
Publications |
|
Administrative Information |
NCT number |
NCT02286089 |
ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT02286089 |
Other study identifiers |
|
Source weblink |
http://clinicaltrials.gov/ct2/show/NCT02286089 |
Public contact |
Email |
patientcare@roche.com |
Public email |
patientcare@roche.com |
|
Sponsors |
Hoffmann-La Roche |
Cells |
Source pluripotent stem cell lines |
|
Which differentiated cell type is used |
Label |
retinal pigment epithelial cell |
Link |
http://purl.obolibrary.org/obo/CL_0002586 |
Description |
An epithelial cell of the retinal pigmented epithelium. |
|
Recruitment |
Recruitment Status |
Active, not recruiting |
Estimated number of participants |
24 |