Journal
ADVANCES IN MEDICAL SCIENCES
Volume 62, Issue 2, Pages 273-279Publisher
ELSEVIER URBAN & PARTNER SP Z O O
DOI: 10.1016/j.advms.2016.12.004
Keywords
Mesenchymal stem cells; Epilepsy; Seizure; Cell therapy; Clinical trial
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Funding
- Ministry of Health of the Republic of Belarus [20120419]
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Purpose: Existing anti-epileptic drugs (AED) have limited efficiency in many patients, necessitating the search for alternative approaches such as stem cell therapy. We report the use of autologous patient-derived mesenchymal stem cells (MSC) as a therapeutic agent in symptomatic drug-resistant epilepsy in a Phase I open label clinical trial (registered as NCT02497443). Patients and methods: The patients received either standard treatment with AED (control group), or AED supplemented with single intravenous administration of undifferentiated autologous MSC (target dose of 1 x 10(6) cells/kg), followed by a single intrathecal injection of neurally induced autologous MSC (target dose of 0.1 x 10(6) cells/kg). Results: MSC injections were well tolerated and did not cause any severe adverse effects. Seizure frequency was designated as the main outcome and evaluated at 1 year time point. 3 out of 10 patients in MSC therapy group achieved remission (no seizures for one year and more), and 5 additional patients became responders to AEDs, while only 2 out of 12 patients became responders in control group (difference significant, P = 0.0135). Conclusions: MSC possess unique immunomodulatory properties and are a safe and promising candidate for cell therapy in AED resistant epilepsy patients. (C) 2017 Medical University of Bialystok. Published by Elsevier B.V. All rights reserved.
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