Neurosurgery Unit, Department of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
Department of Orthopaedics and Traumatology, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.
J Spinal Cord Med. 2023 Jul;46(4):682-686. doi: 10.1080/10790268.2022.2067972. Epub 2022 May 23.
MLC601/MLC901 has demonstrated neuroprotective and neuroregenerative properties that enhance neurological recovery in stroke and traumatic brain injury. We aimed to evaluate its safety and potential efficacy in patients with severe spinal cord injury.
Patients with American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B were included in an open-label cohort study. Each received a course of MLC601/MLC901 for 6 months in addition to standard care and rehabilitation. Key endpoints were safety, AIS grade and motor scores at month 6 (M6).
Among 30 patients included (mean age 42.2 ± 17.6 years, 24 men), 20 patients had AIS A while 10 patients had AIS B at baseline. Ten patients experienced 14 adverse events including one serious adverse event and six deaths, none were considered treatment-related. AIS improved in 25% of AIS A and 50% of AIS B. Improvement in ASIA motor score was seen most with cervical injury (median change from baseline 26.5, IQR: 6-55). These findings appear to be better than reported rates of spontaneous recovery for SCI AIS A and B.
MLC601/MLC901 is safe and may have a role in the treatment of patients with SCI. A controlled trial is justified.
MLC601/MLC901 具有神经保护和神经再生特性，可促进中风和创伤性脑损伤后的神经恢复。我们旨在评估其在严重脊髓损伤患者中的安全性和潜在疗效。
本研究纳入了美国脊髓损伤协会（ASIA）损伤量表（AIS）A 和 B 级的开放性队列研究患者。每位患者在接受标准护理和康复治疗的基础上，额外接受 MLC601/MLC901 治疗 6 个月。主要终点为 6 个月（M6）时的安全性、AIS 分级和运动评分。
30 例患者（平均年龄 42.2±17.6 岁，24 名男性）中，20 例 AIS A 级，10 例 AIS B 级。10 例患者发生了 14 次不良事件，包括 1 次严重不良事件和 6 例死亡，但均与治疗无关。AIS A 级中有 25%的患者和 AIS B 级中有 50%的患者得到改善。颈椎损伤患者的 ASIA 运动评分改善最为明显（从基线中位数变化 26.5，IQR：6-55）。这些发现似乎优于 AIS A 和 B 级 SCI 自发恢复的报告率。
MLC601/MLC901 是安全的，可能对 SCI 患者的治疗有一定作用。需要进行对照试验来进一步验证。
