Stem cells injected into eye aim to halt blindness
NCT ID NCT02286089
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study tests a stem cell therapy called OpRegen for people with advanced dry age-related macular degeneration (geographic atrophy). Researchers inject retinal pigment epithelium cells derived from human embryonic stem cells into the eye to see if they can safely replace damaged cells and slow vision loss. The trial involves 24 participants aged 50 and older with poor central vision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OpRegen (human embryonic stem cell-derived retinal pigment epithelium cells)
- What this could lead to
- If successful, this could slow or stop vision loss from dry age-related macular degeneration, offering a new treatment option for a currently untreatable condition.
- What could go wrong
- This is an early-phase trial with only 24 participants, so results may not apply to everyone. Risks include inflammation, retinal detachment, or the cells not surviving long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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24 people
The number who actually took part.
- Started
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Apr 2015
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 50 and older; * Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes; * Funduscopic findings of dry age-related macular degeneration (AMD) with progressive geographic atrophy in the macula; * Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and 20/64-20/250 in cohort 4 in the study eye by ETDRS vision testing; * Vision in the non-operated eye must be better than or equal to that in the operated eye; * Subjects with sufficiently good health to allow participation in all study-related procedures and complete the study follow up period (based on medical records); * Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care; * Blood counts, blood chemistry, coagulation and urinalysis without abnormal significance; * Negative for tuberculosis (TB) (cohort 4), human immunodeficiency virus (HIV), hepatitis B (HBC), and hepatitis C virus (HCV), negative for cytomegalovirus (CMV) Immunoglobulin (IgM) and Epstein-Barr Virus (EBV) IgM or asymptomatic in the opinion of the investigator (cohort 4); * No history of malignancy (other than a non-melanoma skin cancer). For cancers in remission for more then 5 years enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment; * Willing to defer all future blood and tissue donation; * Able to understand study procedures and willing to sign informed consent. Exclusion Criteria: * Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye; * History or presence of diabetic retinopathy, vascular occlusions, uveitis, Coat's disease, uncontrolled glaucoma, cataract or media opacity preventing posterior pole visualization or any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; * History of retinal detachment repair in the study eye; * Axial myopia greater than -6 diopters; * At least 2 months following cataract removal in the study eye and Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks and any other ocular surgery in the study eye in the past 3 months prior to implantation; * History of cognitive impairments or dementia; * Contraindication for systemic immunosuppression; * History of any condition other than AMD associated with choroidal neovascularization in the study eye (e.g. pathologic myopia or presumed ocular histoplasmosis); * Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the patient at special risk. * Pregnancy or breastfeeding; * Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye. * Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery; * History of cancer (other than a non-melanoma skin cancer). For cancers in remission more than five years ago, enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
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Hadassah Medical Center
Jerusalem, 9112001, Israel
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Kaplan Medical Center
Rehovot, 76100, Israel
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Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
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Rabin Medical Center
Petah Tikva, 4941492, Israel
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Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
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West Coast Retina Medical Group
San Francisco, California, 94109, United States
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Other studies related to the condition(s) this trial covers.
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