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自体嗅黏膜下层移植治疗慢性脊髓损伤:一项前瞻性双盲临床试验的三年随访结果

Autologous Olfactory Lamina Propria Transplantation for Chronic Spinal Cord Injury: Three-Year Follow-Up Outcomes From a Prospective Double-Blinded Clinical Trial.

作者信息

Wang Sheng, Lu Jike, Li Yu-An, Zhou Hui, Ni Wen-Fei, Zhang Xiao-Lei, Zhu Si-Pin, Chen Bo-Bei, Xu Hui, Wang Xiang-Yang, Xiao Jian, Huang Hongyun, Chi Yong-Long, Xu Hua-Zi

机构信息

Department of Spinal Surgery, the Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.

出版信息

Cell Transplant. 2016;25(1):141-57. doi: 10.3727/096368915X688065. Epub 2015 Apr 22.

Abstract

We did a clinical trial to determine whether olfactory mucosa lamina propria (OLP) transplants promote regeneration and functional recovery in chronic human spinal cord injury (SCI). The trial randomized 12 subjects to OLP transplants (n = 8) or control sham surgery (n = 4). The subjects received magnetic resonance imaging (MRI), electromyography (EMG), urodynamic study (UDS), American Spinal Injury Association impairment scale (AIS), and other functional assessments. OLP-transplanted subjects recovered more motor, sensory, and bladder function compared to sham-operated subjects. At 3 years after OLP transplant, one patient improved from AIS A to C and another recovered from AIS A to B, two recovered more than three segmental sensory levels, two had less spasticity, two had altered H-reflexes and SSEP, two regained bladder and anorectal sensation and had improved bladder compliance on UDS. OLP-treated patients had partial or complete tissue bridges at the injury site compared to cavitary gaps in sham-operated patients. The limited recovery suggests that OLP transplants alone do not have significant benefits but may provide a rationale for larger randomized trials or combination therapies.

摘要

我们进行了一项临床试验,以确定嗅黏膜固有层(OLP)移植是否能促进慢性人类脊髓损伤(SCI)的再生和功能恢复。该试验将12名受试者随机分为接受OLP移植组(n = 8)或对照假手术组(n = 4)。受试者接受了磁共振成像(MRI)、肌电图(EMG)、尿动力学研究(UDS)、美国脊髓损伤协会损伤量表(AIS)及其他功能评估。与假手术受试者相比,接受OLP移植的受试者在运动、感觉和膀胱功能方面恢复得更多。在OLP移植3年后,一名患者从AIS A级改善到C级,另一名从AIS A级恢复到B级,两名患者恢复了超过三个节段的感觉水平,两名患者痉挛减轻,两名患者的H反射和体感诱发电位(SSEP)发生改变,两名患者恢复了膀胱和肛门直肠感觉,且尿动力学研究显示膀胱顺应性有所改善。与假手术患者的空洞间隙相比,接受OLP治疗的患者在损伤部位有部分或完整的组织桥接。有限的恢复表明,单独的OLP移植没有显著益处,但可能为更大规模的随机试验或联合治疗提供理论依据。

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