Narges Sharifzadeh1, Ali Ghasemi2, Jalil Tavakol Afshari3, Fatemeh Moharari1, Atefeh Soltanifar1, Ali Talaei1, Hamid Reza Pouryousof4, Mahsa Nahidi1, Mohammad Reza Fayyazi Bordbar1, Maliheh Ziaee5. 1. Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 2. Department of Pediatric Hematology and Oncology, Dr Sheikh Pediatric Hospital, Mashhad University of Medical Sciences, Mashhad, Iran. 3. Immunology Research Center, Avicenna Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran. 4. General Directorate of Welfare, State Welfare Organization of Razavi Khorasan, Mashhad, Iran. 5. Department of Community Medicine, School of Medicine, Social Determinants of Health Research Center, Gonabad University of Medical Sciences, Gonabad, Iran.
Abstract
INTRODUCTION: This study aimed to determine the safety and efficacy of treatment with autologous bone marrow mesenchymal stem cell (BMMSCs) compared with the routine treatment in children with autism spectrum disorder (ASD). METHODS: In this ethically approved randomized controlled trial, 32 ASD children aged 5-15 years were randomly assigned to receive either autologous BMMSC plus rehabilitation therapy and risperidone (intervention group) or rehabilitation therapy and risperidone (control group). Autologous BMMSCs were intrathecally injected in the intervention group twice in 4 weeks. Patients were assessed using childhood autism rating scale (CARS), Gilliam autism rating scale-second edition (GARS-II), and clinical global impression (CGI) at the baseline, as well as 6 and 12 months after intervention. RESULTS: Overall, 32 patients in two groups of intervention (n = 14) and control (n = 18) completed the study, of which 27 (84.4%) were male. Mean age was 9.50 ± 2.14 years. The improvements in CARS total score, GARS-II autism index, and CGI global improvement showed no significant differences between the groups over 12 months. However, the main effect for time*group interaction was significant regarding the CGI-severity of illness, showing a significantly more pronounced improvement in the intervention group (F = 6.719; P = .002). DISCUSSION: Intrathecal injection of autologous BMMSCs seems to be safe and feasible, but has limited clinical efficacy in treatment of children with ASD.
RCT Entities:
INTRODUCTION: This study aimed to determine the safety and efficacy of treatment with autologous bone marrow mesenchymal stem cell (BMMSCs) compared with the routine treatment in children with autism spectrum disorder (ASD). METHODS: In this ethically approved randomized controlled trial, 32 ASD children aged 5-15 years were randomly assigned to receive either autologous BMMSC plus rehabilitation therapy and risperidone (intervention group) or rehabilitation therapy and risperidone (control group). Autologous BMMSCs were intrathecally injected in the intervention group twice in 4 weeks. Patients were assessed using childhood autism rating scale (CARS), Gilliam autism rating scale-second edition (GARS-II), and clinical global impression (CGI) at the baseline, as well as 6 and 12 months after intervention. RESULTS: Overall, 32 patients in two groups of intervention (n = 14) and control (n = 18) completed the study, of which 27 (84.4%) were male. Mean age was 9.50 ± 2.14 years. The improvements in CARS total score, GARS-II autism index, and CGI global improvement showed no significant differences between the groups over 12 months. However, the main effect for time*group interaction was significant regarding the CGI-severity of illness, showing a significantly more pronounced improvement in the intervention group (F = 6.719; P = .002). DISCUSSION: Intrathecal injection of autologous BMMSCs seems to be safe and feasible, but has limited clinical efficacy in treatment of children with ASD.
Authors: Laura Villarreal-Martinez; Laura Elia MartÍnez-Garza; Iram Pablo Rodriguez-Sanchez; Neri Alvarez-Villalobos; Fernando Guzman-Gallardo; Sulia Pope-Salazar; Cynthia Salinas-Silva; Maria Guadalupe Cepeda-Cepeda; Alejandra Garza-Bedolla; Irving Armando Dominguez-Varela; Daniel Zacarias Villarreal-Martinez; Jose Humberto Treviño-Villarreal; David Gomez-Almaguer Journal: Innov Clin Neurosci Date: 2022 Apr-Jun