MedicalResearch.com Interview with:
Steven Levy MD
CEO, MD Stem Cells
Study Director, Stem Cell Treatment Studies
MedicalResearch.com: What is the background for this study?
Response: MD Stem Cells is the sponsor of the Stem Cell Ophthalmology Treatment Study II (SCOTS 2) the largest stem cell study currently addressing retinal and optic nerve disease (NCT 03011541). SCOTS uses autologous bone marrow derived stem cells (BMSC) typically provided to the eyes by combining retrobulbar, subtenons and intravenous injections. Many retinal and optic nerve diseases are eligible including Retinitis Pigmentosa (RP), Age Related Macular Degeneration (AMD), Stargardts, Ushers, Glaucoma, Ischemic Optic Neuropathy, Optic Atrophy and others. Statistically significant improvements have been documented in key diseases and positive responses have been noted across most conditions treated. Mechanisms of action may include differentiation of the CD34 cells into neurons, secretion of neurotrophic factors, transfer of mitochondria and release of mRNA. These may benefit existing stressed cells as well as provide replacement of damaged or absent cells.
MedicalResearch.com: What is Optic Nerve Stroke?
Response: Optic Nerve Stroke or Non-Arteritic Ischemic Optic Neuropathy (NAION) is the most common cause of blindness from optic nerve disease for patients over age 50. Cardiovascular disease may predispose patients. There has also been an association of NAION with use of PDE5 inhibitors such as sildenafil (Viagra). A smallish or ‘crowded’ optic nerve is often associated. Vision is typically severely reduced in the initial eye affected and sequential NAION where the fellow eye develops visual loss has been reported in up to 73% of patients. Occurrence in the second eye may follow weeks, months or even years after the first.
MedicalResearch.com: What are the main findings of your study?
Response: Following therapy in SCOTS, 80% of patients experienced improvement in Snellen binocular vision (p=0.029) with 20% remaining stable. 73.6 % of eyes treated gained vision (p=0.019) and 15.9% remained stable in the post-operative period. There was an average of 3.53 Snellen lines of vision improvement per eye with an average 22.74% and maximum 83.3% improvement in LogMAR acuity per eye. The average LogMAR change in treated eyes was a gain of 0.364 (p=0.0089). Improvements typically manifested no later than 6 months post procedure. Results were statistically significant (p <.05)
MedicalResearch.com: What should readers take away from your report?
Response: Treatment of Optic Nerve Stroke (NAION) is now possible using BMSC as provided in SCOTS. In our report there was statistically significant visual improvement for a sizable majority (80%) of patients with over 73% of individual NAION eyes benefitting from the treatment. Duration of vision loss did not appear to affect responses. No complications were observed. Prior to development of the BMSC protocol in SCOTS there was no effective treatment to improve or stabilize vision for patients with NAION. Patients with NAION desiring improvement in visual acuity should consider participation in SCOTS. Patients with other eye diseases may also consider SCOTS reassured that the methodology has provided benefit in different eye diseases.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We will continue to gather data on new patients treated for NAION as well as existing patients who continue to provide data past the required follow up period. Given the relatively frequent occurrence of sequential NAION, and the known neuroprotective effects of BMSC on the optic nerve, a future study on prevention of NAION in fellow eyes might be considered. A number of different optic neuropathies have responded to treatment in SCOTS including hereditary such as Lebers Hereditary Optic Neuropathy (LHON) and Dominant Optic Atrophy, Glaucoma, and compressive, inflammatory, toxic, autoimmune and other causes of optic atrophies. Potentially combining BMSC with certain medications could further improve outcomes.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: SCOTS 2 provides the opportunity for patients with vision loss to enroll in a patient sponsored clinical study with publications showing the method can provide statistically significant benefit. Interested patients or referring providers may reach us through our website www.mdstemcells.com or email firstname.lastname@example.org We are also conducting studies registered with NIH on neurologic disease and paraplegia from spinal cord injury – these are explained on the website.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
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 Investigation. 2017;4:94. doi:10.21037/sci.2017.11.05.
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