摘要
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。
AIM： To testify the recent safety of olfactory ensheathing cell （OEC） transplantation in the treatment of arnyotrophic lateral sclerosis （ALS）, and further evaluate its metaphase safety. METHODS： The experiment was part of serial researches about OEC transplantation in treatment of ALS. （1）Between December 2004 and May 2005, 13 patients with definite ALS （diagnosed according to the El Escorial criteria of World Federation of Neurology） who received OEC transplantations were selected from the Neuropathy Disease Research and Treatment Center of Beijing Xishan Hospital, and their conditions ongoingly deteriorated. （2）All the patients were treated with fetal OEC transplantation： Fetal olfactory bulb was taken out to digest into single OEC, and then 100μL OEC suspension containing 2 ×10^6 cells was injected, into the corona radiata of frontal lobe bilaterally after 2-3 weeks culture. （3） All patients were assessed with MRI cerebral scan after transplantation and followed regularly to compare the morphological changes of injection site and surrounding cerebral structures and analyze the biological safety of OEC transplantation. RESULTS： According to the intention to treat analysis, totally 13 patients with ALS treated with OEC transplantation who received follow-ups of 5.1- 11.8 months （mean 7.5 months） were involved into the result analysis. No fever, headache, dizziness, nausea, vomiting or other complications of nervous system were observed throughout the follow-up. MRI comparison of preoperative and postoperative scans did not demonstrate any pathological findings, such as new tumor, hemorrhages, edema, cyst formations, infections and disruption of neural structures in the transplant sites and surrounding structures. CONCLUSION： This is the first clinical study demonstrating the over 7-month safety of OEC therapy for ALS.
出处
《中国临床康复》
CSCD
北大核心
2006年第25期24-26,共3页
Chinese Journal of Clinical Rehabilitation
