RecruitingNot ApplicableNCT03011541

Stem Cell Ophthalmology Treatment Study II

Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

Sponsor

MD Stem Cells

Enrollment

500 participants

Start Date

Jan 1, 2016

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria4

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.

Interventions

PROCEDUREArm 1

Procedure/ Surgery: RB (Retrobulbar) Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: ST (Subtenon) Subtenon injection of Bone Marrow Derived Stem Cells (BMSC) Procedure/Surgery: IV (Intravenous) Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)