SCOTS Eye Stem Cell Study pulls ahead in optic nerve treatment

WESTPORT, Conn. - Dec. 21, 2017 - PRLog -- Optic Nerve disease may have finally met its match according to a recent report from the Stem Cell Ophthalmology Study II or SCOTS2 in Florida.  Their stem cell approach continues to prove beneficial across different blinding optic nerve and retinal diseases.

"We are achieving strong improvements across a number of otherwise untreatable optic neuropathies and retinopathies", indicates Jeffrey Weiss MD, Principal Investigator for the study.  "In our recently paper on Non- Arteritic Ischemic Optic Neuropathy¹, over 73% of reported eyes treated with our methodology improved (p< .05) with an average of over 22% improvement in LogMAR acuity.  NAION can be described as a stroke in the optic nerve that typically causes severe visual loss. This is the first approach that is showing statistical significance improvement in this second most common blinding optic neuropathy".

Previous journal reports by SCOTS

Case study and group reports from SCOTS showing strong improvements in vision have already been published.   SCOTS has previously reported the treatment of 2 patients with optic nerve disease.

The first patient, a 32 year-old female with a 5 year history of visual loss secondary to idiopathic optic atrophy was followed at the Wilmer Eye Institute at the Johns Hopkins Hospital.  Pre-treatment best-corrected visual acuity was 20/800 OD and 20/4000 with severe visual field loss. Four months following surgery, the visual acuity had improved to 20/100 OD and 20/40 OS with improvement in the visual fields OU.  At 2 years following initial treatment, and with an intervening second treatment in SCOTS approximately 13 months after the first, the visual improvements reached 20/40-2 OD and 20/30+2 OS.²

The second patient, a 54 year-old female with optic neuropathy was followed at the Nationwide Children's Hospital and The Ohio State University.  Pre-treatment, the visual acuity was 20/350 OD and 20/70 OS with severe visual field loss OU. Six months following treatment, the central visual acuity had improved to 20/150 OD and 20/15 OS with improvement in the visual fields OU. ³

A third patient with Serpiginous Choroidopathy improved from 20/80- to 20/60+1 in the right eye and from 20/50- to 20/20-3 in their left eye with increases in OCT, suggesting value in considering BMSC for atrophic retinal conditions. ⁴

There was also publication on 5 patients with Lebers Hereditary Optic Neuropathy (LHON) treated in SCOTS with visual acuity gains on the Early Treatment Diabetic Retinopathy Study (ETDRS) of up to 35 letters with Snellen acuity improvements from hand motion to 20/200 and from counting fingers to 20/100. Visual field improvements were noted. Macular and optic nerve head nerve layer typically thickened.⁵

Patient funded study approach

Patients pay about USD $20,000 to join and participate in the treatment study.

"We have no grant support and we are not a pharmaceutical company", explains Steven Levy MD, CEO MD Stem Cells and Study Director.  "For patient safety and comfort, treatments are performed at a fully licensed surgical center with board certified anesthesiologists for anesthesia and patient management, a board certified orthopedist for the bone marrow aspiration, FDA cleared medical device and disposables for every patient.  Our study is IRB approved, FDA compliant and registered with the NIH. "

Unfortunately some press coverage has conflated SCOTS with unproven or negative fat stem cell clinic outcomes.  "We are not a stem cell clinic taking fat from patient's 'love handles' and doing procedures in the back of an office" stresses Levy.  "Assurance and quality are the reasons the procedure costs what it does.  This is resulting in statistically significant patient visual benefit and real progress for patients with eye diseases with no effective standard of care. "

The ocular regenerative medicine debate

"Autologous BMSC appear to be the stem cell of choice for a number of optic neuropathies and retinopathies" indicates Levy.  "SCOTS is the first study to show improvement across different eye diseases using BMSC and continues to be the only study with published, statistically significant results into which eligible patients can enroll."

"There is a competition in ocular regenerative medicine that most doctors and patients are not aware of- between the stem cell approach used in SCOTS and other types of stem cells that are either harmful, marginally effective , loss effect quickly, are ethically troubled or years away from biologic approval.  We believe our published results are extremely encouraging to the SCOTS approach.  We will soon be reporting some very exciting results in Retinitis Pigmentosa that we believe will be ground breaking for this disease."

SCOTS2, the Stem Cell Ophthalmology Treatment Study II, is the largest ophthalmology stem cell study registered with the National Institutes of Health: NCT Number 03011541.  For more information: Dr. Steven Levy MD can be reached at MD Stem Cells, Westport, CT 06880. http://www.mdstemcells.com Email: stevenlevy@mdstemcells.com  203-423-9494

References:

1. Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study: bone marrow derived stem cells in the treatment of non-arteritic ischemic optic neuropathy (NAION). Stem Cell Investig 2017; 4:94.

2. Weiss JN, Levy S, Malkin A. Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a preliminary report.  Neural Regen Res. 2015 Jun; 10(6): 982–988.

3. Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study (SCOTS) for retinal and optic nerve diseases: a case report of improvement in relapsing auto-immune optic neuropathy.  Neural Regen Res. 2015 Sep; 10(9): 1507–1515.

4. Weiss JN, Benes SC, Levy S. Stem Cell Ophthalmology Treatment Study (SCOTS): improvement in serpiginous choroidopathy following autologous bone marrow derived stem cell treatment. Neural Regen Res. 2016 [cited 2017 Nov 16];11:1512-6.

5. Weiss JN, Levy S, Benes SC. Stem Cell Ophthalmology Treatment Study (SCOTS): bone marrow-derived stem cells in the treatment of Leber's hereditary optic neuropathy. Neural Regen Res. 2016 Oct;11(10):1685-1694.