Huang Hongyun, Chen Lin, Wang Hongmei, Xi Haitao, Gou Chengqing, Zhang Jian, Zhang Feng, Liu Yancheng
Neurological Research and Treatment Center, Beijing Xishan Hospital, Beijing, 100041, PR China.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2006 Apr;20(4):439-43.
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).
A prospective clinical 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 microl) containing about 1 x 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.
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.
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.
通过磁共振成像（MRI）检查确定胎儿嗅鞘细胞（OEC）移植治疗慢性脊髓损伤（SCI）患者的安全性。
设计一项涉及16例慢性SCI患者的前瞻性临床研究，以探讨胎儿OEC移植治疗SCI的可行性和生物安全性。按照严格的伦理准则，从3 - 4个月大的人工流产胎儿中获取嗅球，并通过胰蛋白酶消化得到单个胎儿OEC。然后将这些细胞培养12 - 17天，准备用于临床。2001年11月至2002年12月，随机纳入16例慢性SCI患者。患者受伤后患有SCI 1.5 - 8年（平均4.3年）。将含有约1×10⁶个胎儿OEC的悬浮液（50微升）注射到患者损伤部位上下的脊髓中。所有患者在移植前进行评估，并在移植后通过MRI随访29 - 42个月（平均38个月）。
随访期间未在任何患者中观察到与细胞相关的不良反应。MRI随访未发现所有患者移植部位出现视神经胶质瘤、肿瘤样肿块、新的出血、水肿、扩张性囊肿、新囊肿形成、感染或神经结构破坏。
这是第一项证明OEC治疗SCI长期安全性的临床研究。结果表明，我们的方案在损伤后38个月内治疗慢性SCI患者是可行且安全的。尽管我们研究的样本量不够大，但研究的阳性结果鼓励我们在该领域进一步研究。
