NCT03011541 Stem Cell Ophthalmology Treatment Study II
| NCT ID | NCT03011541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MD Stem Cells |
| Condition | Retinal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2016-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Steven Levy, MD
STUDY CHAIR
MD Stem Cells
Frequently Asked Questions
Who can join the NCT03011541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03011541 currently recruiting?
Yes, NCT03011541 is actively recruiting participants. Contact the research team at stevenlevy@mdstemcells.com for enrollment information.
Where is the NCT03011541 trial being conducted?
This trial is being conducted at Westport, United States, Coral Springs, United States, Vienna, Austria, Dubai, United Arab Emirates.
Who is sponsoring the NCT03011541 clinical trial?
NCT03011541 is sponsored by MD Stem Cells. The principal investigator is Steven Levy, MD at MD Stem Cells. The trial plans to enroll 500 participants.