Cellular transplants in China: Observational study from the largest human experiment in chronic spinal cord injury
Cellular transplants in China: Observational study from the largest human experiment in chronic spinal cord injury
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DOI：
10.1177/1545968305284675
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发表时间：
2006-03-01
影响因子：
4.2
通讯作者：
Guest, J
中科院分区：
文献类型：
--
作者：
Dobkin, BH;Curt, A;Guest, J
背景。在中国，胎儿脑组织已被移植到400多名脊髓损伤（SCI）患者的病变中。坊间报道是假设手术安全有效的唯一依据。目的比较细胞植入前和植入后1年内接受术前和术后评估的患者的经验和客观结果。方法。黄红云医生在北京进行的7例慢性SCI手术患者的独立观察研究。评估包括磁共振成像的病变位置，美国脊髓损伤协会（ASIA）的协议，残疾的变化，以及围手术期病程的详细历史。结果。纳入和排除标准没有明确定义，因为不同原因的脊髓病分级为ASIA A至D的受试者符合条件。细胞注射部位并不总是与损伤程度相关，包括颈椎高度病变患者的额叶。5名受试者出现并发症，包括脑膜炎。术后短暂性低渗可能是一些生理变化的原因。没有发现临床上有用的感觉运动、残疾或自主神经的改善。结论。这些被称为嗅鞘细胞的移植细胞的表型和命运尚不清楚。围手术期发病率和缺乏功能获益被认为是最严重的临床缺陷。所观察到的程序并没有试图达到安全性或有效性试验的国际标准。在缺乏有效的临床试验方案的情况下，医生不应该向患者推荐这种方法。
Background. In China, fetal brain tissue has been transplanted into the lesions of more than 400 patients with spinal cord injury (SCI). Anecdotal reports have been the only basis for assuming that the procedure is safe and effective. Objective To compare available reports to the experiences and objective findings of patients who received preoperative and postoperative assessments before and up to 1 year after receiving cellular implants. Methods. independent observational study of 7 chronic SCI subjects undergoing surgery by Dr Hongyun Huang in Beijing. Assessments included lesion location by magnetic resonance imaging, protocol of the American Spinal Injury Association (ASIA), change in disability, and detailed history of the perioperative course. Results. Inclusion and exclusion criteria were not clearly defined, as subjects with myelopathies graded ASIA A through D and of diverse causes were eligible. Cell injection sites did not always correlate with the level of injury and included the frontal lobes Of a subject: with a high cervical lesion. Complications, including meningitis, occurred in 5 Subjects. Transient postoperative hypotonicity may have accounted for some physical changes. No clinically useful sensorimotor, disability, or autonomic improvements were found. Conclusions. The phenotype and the fate of the transplanted cells, described as olfactory ensheathing cells, are unknown. Perioperative morbidity and lack of functional benefit were identified as the most serious clinical shortcomings. The procedures observed did not attempt to meet international standards for either a safety or efficacy trial. in the absence of a valid clinical trials protocol, physicians should not recommend this procedure to patients.