Stem Cell Ophthalmology Treatment Study II



Status:Recruiting
Conditions:Neurology, Neurology, Ocular, Ocular, Ocular, Ocular, Ocular, Ocular
Therapuetic Areas:Neurology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:January 2016
End Date:January 2021
Contact:Steven Levy, MD
Email:stevenlevy@mdstemcells.com
Phone:203-423-9494

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Bone Marrow Derived Stem Cell Ophthalmology Treatment Study II

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.

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 from the bone marrow using standard medical and surgical
practices. Retinal conditions may include degenerative, ischemic or physical damage (
examples may include macular degeneration, hereditary retinal dystrophies such as retinitis
pigmentosa, stargardt, non-perfusion retinopathies, post retinal detachment. Optic Nerve
conditions may include degenerative, ischemic or physical damage ( examples may include optic
nerve damage from glaucoma, compression, ischemic optic neuropathy, optic atrophy ).
Injections may include retrobulbar, subtenon, intravitreal, intraocular, subretinal and
intravenous. Patients will be followed for 12 months with serial comprehensive eye
examinations including relevant imaging and diagnostic ophthalmic testing.

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 20/40 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 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.
We found this trial at
2
sites
1308 State Road 7
Margate, Florida 33063
Principal Investigator: Jeffrey N Weiss, MD
Phone: 203-423-9494
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Dubai, Sharjah
Phone: 203-423-9494
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Dubai,
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