Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of non-arteritic ischemic optic neuropathy (NAION).
Jeffrey N Weiss, Steven Levy, Susan C Benes
https://pubmed.ncbi.nlm.nih.gov/29270420/Actively Recruiting
Led by MD Stem Cells · Updated on 2026-06-29
500
Participants Needed
4
Research Sites
52 weeks
Total Duration
Researchers are evaluating the use of autologous bone marrow derived stem cells BMSC to treat vision loss caused by retinal or optic nerve damage that is typically considered irreversible. The study focuses on conditions such as macular degeneration, hereditary retinal dystrophies like retinitis pigmentosa and Stargardt disease, ischemic or physical retinal damage, as well as optic nerve damage from glaucoma, ischemic optic neuropathy, optic atrophy, and other related diseases. Participants will receive injections of their own stem cells isolated from bone marrow using standard medical and surgical procedures. These injections may be given retrobulbarly, subtenon, intravitreal, intraocular, subretinal, and intravenously to one or both eyes. The treatment is provided in a single group format, and patients will be monitored for 12 months following the procedure. During the 12-month follow-up, participants will undergo comprehensive eye exams including imaging and diagnostic ophthalmic tests. Researchers will measure changes in visual acuity, visual fields, and optical coherence tomography results from before the procedure to 12 months after. Safety and treatment effects will be closely monitored through these assessments to evaluate the potential benefits and risks of the stem cell therapy.
CONDITIONS
Stem Cell Ophthalmology Treatment Study II
S
Steven Levy, MD
S
Steven Levy, MD
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MD Stem Cells
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Bone marrow-derived stem cell injections | Usual standard treatment |
|---|---|---|
| What it is | The procedure involves injecting autologous bone marrow-derived stem cells into the eye or systemically via retrobulbar, subtenon, or intravenous routes. | Standard management includes observation, routine eye exams, medical therapy if applicable, and supportive measures for visual function, depending on the underlying condition. |
| Role in trial | This is the single investigational intervention studied for its effect on visual outcomes in adults with retinal or optic nerve disease. | Used as standard care outside clinical trials, aiming to stabilize vision or limit further progression with medical, surgical, or supportive treatments as needed. |
| Primary use | Investigational use for potential improvement in visual acuity or function in patients with stable or progressive retinal or optic nerve disease not expected to benefit from existing treatments. | Primarily aims to maintain vision, slow progression, and provide visual support; improvement is uncommon in advanced disease when prior therapies have been exhausted. |
| How it is given or performed | Bone marrow-derived stem cells are injected either around the eye (retrobulbar or subtenon) or intravenously, with the procedures performed under medical supervision. | Current management may include topical, oral, or injectable medications, observation, rehabilitation, or supportive aids; no stem cell injections are routinely performed in standard care. |
| Evidence status | Early trial and case reports suggest possible improvement in visual function for some patients, but larger studies and published results are needed to establish effectiveness. | Standard management may limit further vision loss or stabilize disease in some patients, but meaningful vision improvement is uncommon in those with advanced or progressive disease. |
| Important limitations | Risks of stem cell procedures include procedure-related complications and unknown long-term benefits; evidence for visual improvement is limited, and effectiveness and safety remain under study. | Current standard care may not improve vision in advanced cases; supportive care offers limited benefit and cannot restore lost visual function. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with 12 months follow-up
Participants receive injections of their own bone marrow derived stem cells into eye areas and intravenously.
Regular follow-up visits for eye exams and imaging
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/32231088/MD Stem Cells
Lead Sponsor