Abstract：
OBJECTIVE: Spinal cord injury (SCI) affects patients\' physical, psychological, and social well-being. Presently, treatment modalities for chronic SCI have restricted clinical effectiveness. Mesenchymal stromal cells (MSCs) demonstrate promise in addressing nervous tissue damage. This single-center, open-label, parallel-group randomized clinical trial aimed to assess the safety and efficacy of intraoperative perilesional administration of expanded autologous bone marrow-derived MSCs (BMMSCs), followed by monthly intrathecal injections, in comparison to monthly intrathecal administration of expanded allogeneic umbilical cord-derived MSCs (UCMSCs) for individuals with chronic SCI.
METHODS: Twenty participants, who had a minimum of 1 year of SCI duration, were enrolled. Each participant in Group A received perilesional BMMSCs, followed by monthly intrathecal BMMSCs for three injections, while Group B received monthly intrathecal UCMSCs for three injections. Safety and efficacy were evaluated using the American Spinal Cord Injury Association (ASIA) score for at least 1 year post the final injection. Statistical analysis was conducted using the Wilcoxon signed-rank test.
RESULTS: Group A comprised 11 participants, while Group B included 9. The mean follow-up duration was 22.65 months. Mild short-term adverse events encompassed headaches and back pain, with no instances of long-term adverse events. Both groups demonstrated significant improvements in total ASIA scores, with Group A displaying more pronounced motor improvements.
CONCLUSIONS: Our findings indicate that perilesional administration of expanded autologous BMMSCs, followed by monthly intrathecal BMMSCs for three injections, or monthly intrathecal UCMSCs for three injections appear to be safe and hold promise for individuals with chronic SCI. Nonetheless, larger-scale clinical trials are imperative to validate these observations.
METHODS: Twenty participants, who had a minimum of 1 year of SCI duration, were enrolled. Each participant in Group A received perilesional BMMSCs, followed by monthly intrathecal BMMSCs for three injections, while Group B received monthly intrathecal UCMSCs for three injections. Safety and efficacy were evaluated using the American Spinal Cord Injury Association (ASIA) score for at least 1 year post the final injection. Statistical analysis was conducted using the Wilcoxon signed-rank test.
RESULTS: Group A comprised 11 participants, while Group B included 9. The mean follow-up duration was 22.65 months. Mild short-term adverse events encompassed headaches and back pain, with no instances of long-term adverse events. Both groups demonstrated significant improvements in total ASIA scores, with Group A displaying more pronounced motor improvements.
CONCLUSIONS: Our findings indicate that perilesional administration of expanded autologous BMMSCs, followed by monthly intrathecal BMMSCs for three injections, or monthly intrathecal UCMSCs for three injections appear to be safe and hold promise for individuals with chronic SCI. Nonetheless, larger-scale clinical trials are imperative to validate these observations.
摘要：
目的：脊髓损伤（SCI）影响患者的身体，心理,和社会福祉。目前,慢性SCI的治疗方式限制了临床有效性。间充质基质细胞（MSC）在解决神经组织损伤方面表现出希望。这个单一中心，开放标签，平行组随机临床试验旨在评估术中周边给药扩增的自体骨髓来源的MSCs（BMMSCs）的安全性和有效性，然后每月鞘内注射,与每月鞘内注射扩增的同种异体脐带来源的MSCs（UCMSCs）治疗慢性SCI患者相比。
方法：20名参与者，SCI持续时间至少为1年的人，已注册。A组的每位参与者均接受病灶周围BMMSCs，然后每月鞘内注射BMMSCs三次，而B组每月接受鞘内UCMSCs三次注射。使用美国脊髓损伤协会(ASIA)评分评估最终注射后至少1年的安全性和有效性。使用Wilcoxon符号秩检验进行统计分析。
结果：A组包括11名参与者，而B组包括9。平均随访时间为22.65个月。轻度短期不良事件包括头痛和背痛，无长期不良事件。两组的ASIA总分均有显著改善，A组显示出更明显的运动改善。
结论：我们的研究结果表明，扩张的自体BMMSCs，然后每月鞘内注射BMMSCs三次，或每月鞘内注射UCMSCs三次似乎是安全的，对慢性SCI患者有希望。尽管如此，需要更大规模的临床试验来验证这些观察结果.
方法：20名参与者，SCI持续时间至少为1年的人，已注册。A组的每位参与者均接受病灶周围BMMSCs，然后每月鞘内注射BMMSCs三次，而B组每月接受鞘内UCMSCs三次注射。使用美国脊髓损伤协会(ASIA)评分评估最终注射后至少1年的安全性和有效性。使用Wilcoxon符号秩检验进行统计分析。
结果：A组包括11名参与者，而B组包括9。平均随访时间为22.65个月。轻度短期不良事件包括头痛和背痛，无长期不良事件。两组的ASIA总分均有显著改善，A组显示出更明显的运动改善。
结论：我们的研究结果表明，扩张的自体BMMSCs，然后每月鞘内注射BMMSCs三次，或每月鞘内注射UCMSCs三次似乎是安全的，对慢性SCI患者有希望。尽管如此，需要更大规模的临床试验来验证这些观察结果.
