{ "data": { "asOf": "2026-10-30T22:23:56.449Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT03011541", "title": "Stem Cell Ophthalmology Treatment Study II", "scientificTitle": "Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II", "status": "recruiting", "studyType": "interventional", "phase": [], "conditions": [ "Retinal Disease", "Age-Related Macular Degeneration", "Retinitis Pigmentosa", "Stargardt Disease", "Optic Neuropathy", "Nonarteritic Ischemic Optic Neuropathy", "Optic Atrophy", "Optic Nerve Disease", "Glaucoma", "Leber Hereditary Optic Neuropathy", "Blindness", "Vision Loss Night", "Vision Loss Partial", "Vision, Low", "Retinopathy", "Maculopathy", "Macular Degeneration", "Retina Atrophy" ], "interventions": [ { "name": "Arm 1", "type": "PROCEDURE", "description": "Procedure/ Surgery: RB (Retrobulbar)\n\nRetrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)\n\nProcedure/Surgery: ST (Subtenon)\n\nSubtenon injection of Bone Marrow Derived Stem Cells (BMSC)\n\nProcedure/Surgery: IV (Intravenous)\n\nIntravenous injection of Bone Marrow Derived Stem Cells (BMSC)" } ], "sponsor": { "name": "MD Stem Cells", "type": "INDUSTRY" }, "locations": [ { "city": "Westport", "country": "United States", "facility": "MD Stem Cells" }, { "city": "Coral Springs", "country": "United States", "facility": "MD Stem Cells" }, { "city": "Vienna", "country": "Austria", "facility": "MD Stem Cells Kobinia Med" }, { "city": "Dubai", "country": "United Arab Emirates", "facility": "The Saudi-German Hospital" } ], "outcomes": { "other": [], "primary": [ "Visual Acuity" ], "secondary": [ "Visual Fields", "Optical Coherence Tomography (OCT)" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Have objective, documented damage to the retina or optic nerve unlikely to improve OR\n* Have objective, documented damage to the retina or optic nerve that is progressive AND have less than or equal to 20/30 best corrected central visual acuity in one or both eyes AND/OR an abnormal visual field in one or both eyes.\n* Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.\n* If under current medical therapy ( pharmacologic treatment) for a retinal or optic nerve disease be considered stable on that treatment and unlikely to have visual function improvement ( for example, glaucoma with intraocular pressure stable on topical medications but visual field damage ).\n* Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n* Be over the age of 18\n* Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure.\n* Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n* Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.\n* Patients who are not capable or not willing to undergo follow up eye exams with the principle investigator or their ophthalmologist or optometrist as outlined in the protocol.\n* Patients who are not capable of providing informed consent.\n* Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 500 }, "startDate": "2016-01-01", "completionDate": "2028-07-31", "lastUpdated": "2026-06-29T00:00:00.000Z", "firstPosted": "2017-01-05T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT03011541" ] }, 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