嗅鞘细胞移植治疗晚期脊髓损伤安全性评价38个月磁共振随访结果(英文)

Safety of Fetal Olfactory Ensheathing Cell Transplan-tation in Patients with Chronic Spinal Cord Injury A 38-Month Follow-up with MRI

目的 对晚期脊髓损伤（spinal and injury，SCI）的治疗是极具挑战性的研究。动物实验证明，嗅鞘细胞（olfactory ensheathing cell，OEC）具有较强的修复损伤脊髓的能力。在证明OEC移植治疗晚期SCI患者的近期安全性和有效性的基础上，进一步评价其长期安全性。方法2001年11月～2002年12月采用OEC移植治疗晚期SCI患者171例，随机选择其中16例临床资料回顾性分析。男14例，女2例；年龄22～55岁。受伤至接受移植治疗1年5个月～8年，平均4．4年。所有患者均接受胚胎OEC移植治疗，即取3～4个月胚胎嗅球，消化成单个OEC后，培养12～17d后，移植到脊髓损伤部位的上下处，共50μl细胞悬液（1×10^6个细胞）。术后采用1.5T MRI脊髓扫描定期随访，研究OEC移植物的生物安全性。结果患者获随访29～42个月，平均38个月。随访期间，无细胞移植相关性副反应。术前术后MRI扫描对比，脊髓移植部位及其周围未发现新生肿瘤、出血、水肿、囊性变形成、神经结构破坏以及感染（脓肿）等病理性改变。结论OEC移植治疗脊髓损伤38个月内是安全的，长期疗效有待进一步总结。

Objective To determine the safety of the fetal olfactory ensheathing cell（OEC） transplantation in patients with chronic spinal cord injury （SCI） by examination of the magnetic resonance imaging （MRI）. Methods A prospective chnical study involving 16 patients with chronic SCI was designed to investigate the feasibility and biological safety of the fetal OEC transplantation in treatment of SCI. The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use. From November 2001 to December 2002, 16 patients with chronic SCI were randomly enrolled. The patients suffered from SCI for 1.5-8 years （average 4.3 years） after the injury. The suspension （50 μl） containing about 1×10^6 fetal OECs was transplanted by an injection into the patients＇ spinal cords above and below the injury site. All the patients were assessed before the transplantation and were followed up with MRI for 29-42 months （average 38 mon） after the transplantation. Results No cell-related adverse effects were observed in any patient during the follow-up period. The follow-up with MRI did not reveal any development of optic glial tumor, tumor-like mass, new hemorrhage, edema, expanding cyst, new cyst formation, infection or disruption of the neural structure in the transplant site of all the patients. Condusion This is the first clinical study demonstrating the long-term safety of the OEC therapy for SCI. The results indicate that our protocol is feasible and safe in treatment of patients with chronic SCI within 38 months after the injury. Although the size of the samples for our study was not big enough, the positive results of the study have encouraged us to make a further research in this field.