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ISSN: 2329-6895

Journal of Neurological Disorders
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Research Article

Seizures as an Adverse Event of Cellular Therapy in Pediatric Neurological Disorders and its Prevention

Alok Sharma1, Hemangi Sane2, Amruta Paranjape2*, Nandini Gokulchandran1, Mansi Takle3 and Prerna Badhe1
1Department of Medical Services and Clinical research, NeuroGen Brain and Spine Institute, Chembur, Mumbai, India
2Department of Research and development, NeuroGen Brain and Spine Institute,Chembur, Mumbai, India
3Department of Neurorehabilitation, NeuroGen Brain and Spine Institute, Chembur, Mumbai, India
Corresponding Author : Amruta Paranjape
NeuroGen Brain and Spine Institute
Surana Sethia Hospital, Suman Nagar
Sion-Trombay road, Chembur (East)
Mumbai,India
Tel: + 919819430984
E-mail: [email protected]
Received April 17, 2014; Accepted June 03, 2014; Published June 06, 2014
Citation: Sharma A, Sane H, Paranjape A, Gokulchandran N, Takle M, et al. (2014) Seizures as an Adverse Event of Cellular Therapy in Pediatric Neurological Disorders and its Prevention. J Neurol Disord 2:164. doi: 10.4172/2329-6895.1000164
Copyright: © 22014 Sharma A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Abstract

This study reports seizures as an adverse event (AE) in children with neurological diseases treated with autologous bone marrow mononuclear cells (BMMNCs) intrathecal transplantation. It also assesses the effectiveness of antiepileptic prophylactic regimen to reduce the incidence of seizures as an AE. Seizures were considered as an AE if there were increased pre-existing seizures or new onset seizures. In part I; seizures as an AE was analyzed in detail. Seizures occurred as an AE in 8/131 (6%) in part I. Out of these 8, one patient’s EEG was not available, but showed increased preexisting seizures and 7 had a pre-existing epileptogenic focus on EEG. Out of these 7, 3 developed new onset seizures and 4 had increased pre-existing seizures. Based on this analysis an antiepileptic prophylactic regimen was designed. In Part II effect of this regimen was studied and a significant decrease in the incidence of seizures as an AE was observed along with no new onset seizures. Though small proportions of patients show seizures as an AE of cellular therapy, it definitely requires attention and is preventable. Pre-existing epileptogenic focus is an independent predictor for seizures as an AE. Future clinical trials of cellular therapy in pediatric population may consider these findings.

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