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目的:在证明嗅鞘细胞移植治疗肌萎缩侧索硬化症的近期安全性的基础上,进一步评价其中期安全性。方法:本项研究为嗅鞘细胞移植治疗肌萎缩侧索硬化症系列研究的一部分。①随机选择2004-12/2005-05北京西山医院神经疾病研究治疗中心采用嗅鞘细胞移植治疗肌萎缩侧索硬化症患者13例,均经过世界神经病联合会ElEscorial诊断标准确诊,病情呈进行性恶化趋势。②所有患者均接受胚胎嗅鞘细胞移植治疗,即取胚胎嗅球,消化成单个嗅鞘细胞后,培养两三周,然后在患者双侧大脑放射冠处各注射50μL嗅鞘细胞悬液,细胞数共约2×106个。③术后采用MRI颅脑扫描进行影像学检查,定期随访,仔细比较注射部位及其周围脑结构的形态学变化,分析嗅鞘细胞移植物的生物安全性。结果:按意向处理分析,嗅鞘细胞移植治疗肌萎缩侧索硬化症患者13例,随访5.1～11.8个月,平均7.5个月,全部进入结果分析。随访期间,无发热、头痛、头晕、恶心及呕吐等神经系统并发症。术前术后MRI扫描对比,颅内移植部位及其周围未发现新生肿瘤、出血、水肿、囊肿形成、神经结构破坏以及感染(脓肿)等病理性改变。结论:本研究首次证明在7个月随访期内,采用嗅鞘细胞移植手术治疗肌萎缩侧索硬化症是安全的。
OBJECTIVE: To further evaluate its mid-term safety on the basis of demonstrating the recent safety of olfactory ensheathing cell transplantation in the treatment of amyotrophic lateral sclerosis. METHODS: This study is part of a series of studies on the treatment of amyotrophic lateral sclerosis with olfactory ensheathing cell transplantation. ① randomly selected 2004-12 / 2005-05 Beijing Xishan Hospital neuropathy research and treatment center using olfactory ensheathing cell transplantation in patients with amyotrophic lateral sclerosis in 13 cases were diagnosed by the World Federation of Neurological Elsscorial diagnostic criteria, the condition was progressively worsened trend. ②All patients received embryo olfactory ensheathing cell transplantation, that is, take embryonic olfactory bulb, digested into single olfactory ensheathing cells, cultured for two or three weeks, and then injected 50 μL of olfactory ensheathing cell suspension in the bilateral cerebrum radiation crowns, A total of about 2 × 106 months. ③ MRI scan was performed after operation for imaging examination and regular follow-up. The morphological changes of the injection site and surrounding brain structures were carefully compared to analyze the biological safety of the OECs. Results: According to the intention-to-treat analysis, 13 patients with amyotrophic lateral sclerosis were treated with olfactory ensheathing cell transplantation and were followed up for 5.1-11.8 months with an average of 7.5 months, all of which were involved in the result analysis. No follow-up period, no fever, headache, dizziness, nausea and vomiting and other neurological complications. Compared with preoperative and postoperative MRI scan, no pathological changes such as neoplasm, hemorrhage, edema, cyst formation, nerve structure destruction and infection (abscess) were found in and around the intracranial transplantation site. CONCLUSIONS: This study, for the first time, demonstrates that the use of olfactory ensheathing cell transplantation for the treatment of amyotrophic lateral sclerosis is safe during the seven-month follow-up period.