What is this study evaluating for retinal and optic nerve damage?

This study is evaluating the use of autologous bone marrow derived stem cells to treat vision loss caused by retinal or optic nerve conditions. Researchers want to see if stem cell injections can improve vision in eyes affected by damage that is usually considered irreversible. The study is sponsored by MD Stem Cells and aims to assess changes in vision over 12 months after treatment.

Who may be eligible for this retinal and optic nerve clinical trial?

Adults 18 years or older with documented retinal or optic nerve damage that is unlikely to improve or is progressing may be eligible. Participants should have stable vision or be stable on current treatment and be medically cleared for the procedure. The trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this retinal and optic nerve clinical trial?

Study-related care, including the stem cell procedure and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any out-of-pocket costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID03011541

Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II for Retinal and Optic Nerve Damage

Led by MD Stem Cells · Updated on 2025-03-20

500

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

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 generally considered irreversible. The study focuses on conditions such as macular degeneration, hereditary retinal dystrophies including retinitis pigmentosa and Stargardt disease, ischemic retinopathies, optic nerve damage from glaucoma, ischemic optic neuropathy, and optic atrophy. The goal is to assess whether these stem cells can improve vision in affected eyes. Participants will receive a combination of injections of their own bone marrow derived stem cells through several methods, including retrobulbar, subtenon, intravenous, intravitreal, intraocular, or subretinal injections. The treatment is administered using standard medical and surgical techniques. The study has one treatment group receiving these injections in one or both eyes. After treatment, participants will be followed for 12 months, during which they will have regular comprehensive eye exams with imaging and diagnostic tests. Throughout the study, participants will undergo assessments such as visual acuity tests, visual field measurements, and Optical Coherence Tomography OCT scans to monitor changes from before the procedure to 12 months after. Researchers will track vision improvements and any changes in eye structure or function. Safety and health will be closely monitored, and participants must attend follow-up eye exams as scheduled. The total participation time is about one year post-treatment.

CONDITIONS

Brief Title

Stem Cell Ophthalmology Treatment Study II

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Have documented retinal or optic nerve damage unlikely to improve or progressive damage with 20/30 or worse best corrected central visual acuity or abnormal visual field in one or both eyes
Be at least 3 months post-surgical treatment for eye disease and stable
If on medical therapy for retinal or optic nerve disease, be stable and unlikely to improve
Have potential for improvement with stem cell treatment and minimal risk from the procedure
Be 18 years of age or older
Be medically stable and cleared by a primary care physician for the procedure

You will not qualify if you...

Unable to undergo adequate ophthalmologic examination to document eye pathology
Unable or unwilling to attend follow-up eye exams as outlined in the protocol
Unable to provide informed consent
At significant risk to general health or eye function if undergoing the procedure

Research Team

Steven Levy, MD

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