Stem Cell Ophthalmology Treatment Study II

Launched by MD STEM CELLS · Jan 3, 2017

Keywords

ClinConnect Summary

The Stem Cell Ophthalmology Treatment Study II is a clinical trial investigating the use of stem cells derived from a patient’s own bone marrow to treat various eye conditions that cause damage to the retina or optic nerve, such as age-related macular degeneration and glaucoma. The goal is to see if this treatment can help improve vision in individuals who have significant vision loss or progressive eye diseases.

To be eligible for this study, participants must be at least 18 years old and have documented damage to their retina or optic nerve that is not expected to improve on its own. They should also be stable after any previous eye surgeries and on medications, if applicable, without significant improvement in vision. Participants can expect to undergo a thorough evaluation and, if eligible, receive the stem cell treatment while being closely monitored for safety and any potential effects on their vision. This study is currently recruiting participants who meet these criteria and are interested in exploring new treatment options for their eye conditions.

Gender

ALL

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.