Neurological Disorders

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

Abstract

Alok Sharma, Hemangi Sane, Amruta Paranjape, Nandini Gokulchandran, Mansi Takle and Prerna Badhe

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.