Aghayan Hamid Reza, Arjmand Babak, Yaghoubi Mohsen, Moradi-Lakeh Maziar, Kashani Homa, Shokraneh Farhad
1. MD, PhD, GMP, Compliant Stem Cell Manufacturing Facility, Brain and Spinal Cord Injury Research Center, Tehran University of Medical Sciences, Tehran, Iran.
2. MD, PhD, GMP, Compliant Stem Cell Manufacturing Facility, Chronic Diseases Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Med J Islam Repub Iran. 2014 Oct 14;28:112. eCollection 2014.
Cell-based therapies can be used to treat neurological diseases and spinal cord injuries. The aim of this study was to assess the clinical outcome of bone marrow derived mononuclear cells (BM-MNCs) transplantation in patients with spinal cord injuries.
Following a systematic review to detect clinical intervention studies, a meta-analysis was done for pooling data to estimate the outcome of BM-MNCs transplantation. The percentage of the patients with improved ASIA scale from one grade to a higher grade was defined as the main outcome. By considering the study design and outcome measurement, two reviewers independently extracted the data.
Eight relevant primary studies were found; seven qualified studies, with a combined total of 328 patients were assessed by meta-analysis, including 314 ASIA-A, 13 ASIA-B, 94 cervical, 227 thoracic and 60 acute injuries. The percentage of the patients' improvement was tested by meta-analysis through random and fixed models. The overall percentage of all patients' improved ASIA scale after a one- year follow-up (95% CIs) was 43 (0.27-0.59).
Data from published trials revealed that encouraging results were achieved by autologous BMMNCs for the treatment of spinal cord injury. However, the number of clinical trials included in the systematic review was too limited to reach a definite conclusion. More qualified clinical trials with standardized methods are needed to truly justify the outcome of this therapeutic modality in SCI patients.
基于细胞的疗法可用于治疗神经系统疾病和脊髓损伤。本研究旨在评估骨髓来源的单个核细胞(BM-MNCs)移植治疗脊髓损伤患者的临床疗效。
在系统检索临床干预研究后,进行荟萃分析以汇总数据,估计BM-MNCs移植的疗效。将美国脊髓损伤协会(ASIA)分级提高一个等级的患者百分比定义为主要疗效指标。根据研究设计和疗效测量方法,两名研究者独立提取数据。
共检索到8项相关的原始研究;7项符合条件的研究纳入荟萃分析,共计328例患者,其中ASIA-A级314例,ASIA-B级13例,颈椎损伤94例,胸椎损伤227例,急性损伤60例。采用随机效应模型和固定效应模型对患者改善百分比进行荟萃分析。随访1年时,所有患者ASIA分级改善的总体百分比(95%CI)为43%(0.27 - 0.59)。
已发表试验的数据显示,自体BM-MNCs治疗脊髓损伤取得了令人鼓舞的结果。然而,纳入系统评价的临床试验数量有限,无法得出明确结论。需要更多采用标准化方法的高质量临床试验,以证实这种治疗方式对脊髓损伤患者的疗效。