Stem Cell Ophthalmology Treatment Study II

{ "Stem Cell Ophthalmology Treatment Study II for Retinal and Optic Nerve Damage", "This study is looking at how well injections of your own bone marrow derived stem cells (BMSC) can treat damage to your retina or optic nerve. This includes conditions like age-related macular degeneration, retinitis pigmentosa, Stargardt disease, and optic neuropathy. You might be able to join if you have documented damage to your retina or optic nerve that isn't likely to improve, or if it's getting worse and affects your vision. The main goal is to see if your vision improves after 12 months. The study is currently unclear on its recruitment status and plans to enroll up to 500 participants.", "design": "This is an interventional study with a planned enrollment of 500 participants. It involves different ways of injecting bone marrow derived stem cells.", "commitments": "You would receive injections of your own bone marrow derived stem cells, which could be given in different ways (retrobulbar, subtenon, intravenous). You will have comprehensive eye exams and diagnostic tests for 12 months.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for 12 months after the procedure to measure changes in visual acuity.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Stem Cell Ophthalmology Treatment Study II

Recruiting

NAAges 18+InterventionalTreatment

MD Stem Cells

~500 participants

Updated 2026-06-29 on ClinicalTrials.gov

What's tested:Arm 1

At a glance

Recruiting sites

4 of 4 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Visual Acuity

Measured over Change from pre-procedure to 12 months

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

Where it's being run

4 sites across 4 states

Connecticut1

Florida1

Austria1

United Arab Emirates1

Study leadership

Steven Levy, MD · STUDY_CHAIR · MD Stem Cells
Jeffrey Weiss, MD · PRINCIPAL_INVESTIGATOR · Coral Springs Florida, Vienna Austria, Dubai UAE

Who to contact

Steven Levy, MD

[email protected]

203-423-9494

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Visual AcuityChange from pre-procedure to 12 months
Best corrected visual acuity will be measured with Snellen Eye Chart and the ETDRS (Early Treatment Diabetic Retinopathy Study)Eye Chart when available at each post- procedure visit. Intervals at minimum will be first post- procedure day,then 3 months, 6 months and 12 months post-procedure day. Recommended visit 1 month post -procedure day.

Trialytics