Status:
UNKNOWN
Stem Cell Ophthalmology Treatment Study
Lead Sponsor:
MD Stem Cells
Conditions:
Retinal Disease
Macular Degeneration
Eligibility:
All Genders
18+ years
Phase:
NA
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. http://mdstemcells.com/scots-ii/
Detailed Description
Eyes with loss of vision from retinal or optic nerve conditions generally considered irreversible will be treated with a combination of injections of autologous bone marrow derived stem cells isolated...
Eligibility Criteria
Inclusion
- 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 20/40 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
- 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01920867
Start Date
August 1 2012
End Date
July 1 2020
Last Update
October 23 2019
Active Locations (1)
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1
MD Stem Cells
Westport, Connecticut, United States, 06880