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Clinical Trials in the USA / NCT03011541
Recruiting Not applicable

Stem Cell Ophthalmology Treatment Study II

NCT03011541 · tracked via the Priya Life Science USA tracker
Sponsor
MD Stem Cells
Phase
Not applicable
Started
2016-01
Last updated
2026-06-29

Condition(s) studied

Retinal DiseaseAge-Related Macular DegenerationRetinitis PigmentosaStargardt DiseaseOptic NeuropathyNonarteritic Ischemic Optic NeuropathyOptic AtrophyOptic Nerve DiseaseGlaucomaLeber Hereditary Optic NeuropathyBlindnessVision Loss NightVision Loss PartialVision, LowRetinopathyMaculopathyMacular DegenerationRetina Atrophy

Investigational drug(s) / intervention(s)

Arm 1

Arm 1: Procedure/ Surgery: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)

Study summary

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have objective, documented damage to the retina or optic nerve unlikely to improve OR * 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. * Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable. * 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 ). * Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure. * Be over the age of 18 * Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. * 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. Exclusion Criteria: * Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology. * 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. * Patients who are not capable of providing informed consent. * Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
MD Stem Cells Westport Connecticut Recruiting
MD Stem Cells Coral Springs Florida Recruiting
MD Stem Cells Kobinia Med Vienna Austria Recruiting
The Saudi-German Hospital Dubai United Arab Emirates Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03011541 on ClinicalTrials.gov ↗ ← All trials in the USA