Using stem cells to treat retinal and optic nerve damage
Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II
This study is testing if using stem cells from your own bone marrow can help improve vision in people with serious eye damage from conditions like age-related macular degeneration and optic nerve problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MD Stem Cells Industry-sponsored |
| Locations | 4 sites (Westport, Connecticut and 3 other locations) |
| Trial ID | NCT03011541 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of autologous bone marrow derived stem cells (BMSC) in treating irreversible vision loss caused by retinal and optic nerve conditions. Patients with documented damage to their retina or optic nerve will receive injections of BMSC through various methods, including retrobulbar and intravitreal injections. The study aims to assess the safety and potential improvement in vision over a 12-month follow-up period, with comprehensive eye examinations and diagnostic testing conducted throughout. Conditions targeted include age-related macular degeneration, retinitis pigmentosa, and optic neuropathy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with documented, stable retinal or optic nerve damage that is unlikely to improve with conventional treatments.
Not a fit: Patients with conditions that are not documented or are reversible may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could restore vision or halt the progression of vision loss in patients with severe retinal and optic nerve diseases.
How similar studies have performed: Other studies using stem cell therapies for retinal diseases have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Westport, Connecticut and 3 other locations
- MD Stem Cells — Westport, Connecticut, United States (Recruiting)
- MD Stem Cells — Coral Springs, Florida, United States (Recruiting)
- MD Stem Cells Kobinia Med — Vienna, Austria, Austria (Recruiting)
- The Saudi-German Hospital — Dubai, United Arab Emirates, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Jeffrey Weiss, MD — Coral Springs Florida, Vienna Austria, Dubai UAE
- Study coordinator: Steven Levy, MD
- Email: stevenlevy@mdstemcells.com
- Phone: 203-423-9494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.