Intrathecal autologous bone marrow stem cell therapy in children with autism: A randomized controlled trial

IF 2.8 3区医学 Q2 PSYCHIATRY

Asia‐Pacific Psychiatry Pub Date : 2020-11-04 DOI:10.1111/appy.12445

Narges Sharifzadeh MD, Ali Ghasemi MD, Jalil Tavakol Afshari MD, Fatemeh Moharari MD, Atefeh Soltanifar MD, Ali Talaei MD, Hamid Reza Pouryousof MD, Mahsa Nahidi MD, Mohammad Reza Fayyazi Bordbar MD, Maliheh Ziaee MD

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引用次数: 10

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.

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鞘内自体骨髓干细胞治疗儿童自闭症:一项随机对照试验

本研究旨在确定自体骨髓间充质干细胞(BMMSCs)治疗儿童自闭症谱系障碍(ASD)的安全性和有效性，并与常规治疗进行比较。方法将32例5 ~ 15岁的ASD儿童随机分为两组，一组接受自体骨髓间充质干细胞联合康复治疗和利培酮(干预组)，另一组接受康复治疗和利培酮(对照组)。干预组在4周内鞘内注射2次自体骨髓间充质干细胞。采用儿童自闭症评定量表(CARS)、Gilliam自闭症评定量表-第二版(gar - ii)和临床总体印象(CGI)在基线以及干预后6个月和12个月对患者进行评估。结果干预组(n = 14)和对照组(n = 18)共32例患者完成研究，其中男性27例(84.4%)。平均年龄9.50±2.14岁。CARS总分、gar - ii自闭症指数和CGI总体改善在12个月内各组间无显著差异。然而，对于cgi -疾病严重程度，时间*组交互作用的主效应是显著的，干预组的改善更为显著(F = 6.719;P = .002)。鞘内注射自体骨髓间充质干细胞似乎是安全可行的，但治疗儿童ASD的临床疗效有限。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Asia‐Pacific Psychiatry PSYCHIATRY-

CiteScore

7.80

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Asia-Pacific Psychiatry is an international psychiatric journal focused on the Asia and Pacific Rim region, and is the official journal of the Pacific Rim College of Psychiatrics. Asia-Pacific Psychiatry enables psychiatric and other mental health professionals in the region to share their research, education programs and clinical experience with a larger international readership. The journal offers a venue for high quality research for and from the region in the face of minimal international publication availability for authors concerned with the region. This includes findings highlighting the diversity in psychiatric behaviour, treatment and outcome related to social, ethnic, cultural and economic differences of the region. The journal publishes peer-reviewed articles and reviews, as well as clinically and educationally focused papers on regional best practices. Images, videos, a young psychiatrist''s corner, meeting reports, a journal club and contextual commentaries differentiate this journal from existing main stream psychiatry journals that are focused on other regions, or nationally focused within countries of Asia and the Pacific Rim.