Stem Cell & Translational Neurosciences Lab, Department of Neurosurgery, JPNA Trauma Center, All India Institute of Medical Sciences, New Delhi, India.
University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi, India.
J Clin Neurosci. 2022 Jun;100:7-14. doi: 10.1016/j.jocn.2022.03.033. Epub 2022 Mar 31.
Due to lack of well-designed trials, there is no good evidence on the efficacy of stem cells in spinal cord injury. We aim to study the efficacy and outcome of bone marrow derived stem cells (BMSCs) in acute complete spinal cord injury (SCI). In this prospective study over a 3-year period, 27 patients with acute, complete SCI were randomized to receive BMSCs or placebo (intramedullary route) intraoperatively. Institutional ethics approval was taken and informed consent was taken from all patients. Functional outcome was assessed using ASIA scale, SCIM score and SSEP responses preoperatively, three and six months after surgery. Thirteen patients were available for final analysis of which six were in the stem cell group and seven received placebo. 6 patients had improvement by at least one grade in ASIA score in the stem cell group as compared to only one patient in the placebo group. However, no functional motor improvement in any of the patients. ASIA sensory score improved from a preoperative mean of 124 to 224 at 6 months compared to the static mean of 115 in the control group. Absent SSEP waveform converted to abnormal waveform at 6 months in 3 patients in the stem cell group and one patient in the control group. There was no significant difference in the SCIM scores between the groups at last follow-up. All patients in the stem cell group reported improved bladder sensation, decreased spasticity and improved posture control as compared to nine in the placebo group. BMSCs through intramedullary route are a potential therapy for acute complete SCI and more research is required in this area.
由于缺乏精心设计的试验，干细胞在脊髓损伤中的疗效尚无良好证据。我们旨在研究骨髓来源的干细胞（BMSCs）在急性完全性脊髓损伤（SCI）中的疗效和结果。在这项为期 3 年的前瞻性研究中，27 例急性完全性 SCI 患者被随机分为接受 BMSCs 或安慰剂（髓内途径）的手术治疗。我们获得了机构伦理批准，并获得了所有患者的知情同意。术前、术后 3 个月和 6 个月采用 ASIA 量表、SCIM 评分和 SSEP 反应评估功能结果。最终有 13 例患者可进行最终分析，其中 6 例在干细胞组，7 例接受安慰剂。与安慰剂组相比，干细胞组中有 6 例 ASIA 评分至少提高了 1 级，而只有 1 例患者有功能运动改善。然而，任何患者的运动功能均无改善。ASIA 感觉评分从术前平均 124 分提高到 6 个月时的 224 分，而对照组的平均为 115 分。干细胞组的 3 例患者和对照组的 1 例患者的 SSEP 波形由无到异常。在最后一次随访时，两组的 SCIM 评分无显著差异。与安慰剂组的 9 例患者相比，干细胞组的所有患者均报告说膀胱感觉改善、痉挛减少和姿势控制改善。经髓内途径注射 BMSCs 是急性完全性 SCI 的一种潜在治疗方法，该领域需要进一步研究。
