Objective To study the effect and mechanism of neurological function recovery in rats with spinal cord injury ( SCI) rats after transplantation of neural stem cells which are directly differentiated from bone marrow m...Objective To study the effect and mechanism of neurological function recovery in rats with spinal cord injury ( SCI) rats after transplantation of neural stem cells which are directly differentiated from bone marrow mesenchymal stem cells ( BMSC ) ,and to investigate the suitable engraftment time. Methods BMSC at 3rd passage were differentiated into neural stem cells ( NSC) , and immunofluorescence staining was used to展开更多
Background MLC1501,consisting of four herbs,that is,Radix Astragali,Radix Angelicae sinensis,Rhizoma Chuanxiong,Radix Polygalae,has the same pharmacological properties as its precursors MLC601 and MLC901 which contain...Background MLC1501,consisting of four herbs,that is,Radix Astragali,Radix Angelicae sinensis,Rhizoma Chuanxiong,Radix Polygalae,has the same pharmacological properties as its precursors MLC601 and MLC901 which contain extracts of nine herbs and showed neuroprotective,anti-inflammatory and neurorestorative properties in non-clinical models,as well as clinical benefits in improving functional and neurological recovery after brain injuries.Aims To determine the efficacy of MLC1501 on motor recovery as measured by Fugl-Meyer motor Assessment(FMA)total score at 24 weeks in patients with ischaemic stroke(IS).Design A total of 300 patients aged>18 years,diagnosed with IS in the prior 2-10 days,with National Institute of Health Stroke Scale(NIHSS)total score of 8-18 and a combined score of≥3 on NIHSS motor items 5A,5B,6A and/or 6B,will be randomised in a 1:1:1 ratio to receive oral placebo,MLC1501 low dose or MLC1501 high dose for 6 months.The study is governed by a Steering Committee.An independent Data Monitoring Committee oversees patient safety.Outcomes The primary outcome is mean change from baseline in FMA total score at 24 weeks.Efficacy outcomes evaluated in person at baseline,12 weeks and 24 weeks include the FMA(total,upper extremity and lower extremity motor scores),modified Rankin Scale(mRS),Patient-Reported Outcomes Measurement Information System-Global Health(PROMIS-10)and NIHSS.Additionally,telephone assessment at week 4 includes the simplified mRS and PROMIS-10.Safety will be evaluated by standard assessments and occurrence of adverse events over the duration of the study.Discussion Interventions that enhance recovery beyond the acute period of stroke are needed.MLC1501 has a good safety profile as well as potential to be a treatment for recovery after brain injury.The results of this study will provide objective level B evidence on the efficacy of MLC1501 on long-term recovery and safety of 24 weeks of treatment among patients with IS.展开更多
文摘Objective To study the effect and mechanism of neurological function recovery in rats with spinal cord injury ( SCI) rats after transplantation of neural stem cells which are directly differentiated from bone marrow mesenchymal stem cells ( BMSC ) ,and to investigate the suitable engraftment time. Methods BMSC at 3rd passage were differentiated into neural stem cells ( NSC) , and immunofluorescence staining was used to
文摘Background MLC1501,consisting of four herbs,that is,Radix Astragali,Radix Angelicae sinensis,Rhizoma Chuanxiong,Radix Polygalae,has the same pharmacological properties as its precursors MLC601 and MLC901 which contain extracts of nine herbs and showed neuroprotective,anti-inflammatory and neurorestorative properties in non-clinical models,as well as clinical benefits in improving functional and neurological recovery after brain injuries.Aims To determine the efficacy of MLC1501 on motor recovery as measured by Fugl-Meyer motor Assessment(FMA)total score at 24 weeks in patients with ischaemic stroke(IS).Design A total of 300 patients aged>18 years,diagnosed with IS in the prior 2-10 days,with National Institute of Health Stroke Scale(NIHSS)total score of 8-18 and a combined score of≥3 on NIHSS motor items 5A,5B,6A and/or 6B,will be randomised in a 1:1:1 ratio to receive oral placebo,MLC1501 low dose or MLC1501 high dose for 6 months.The study is governed by a Steering Committee.An independent Data Monitoring Committee oversees patient safety.Outcomes The primary outcome is mean change from baseline in FMA total score at 24 weeks.Efficacy outcomes evaluated in person at baseline,12 weeks and 24 weeks include the FMA(total,upper extremity and lower extremity motor scores),modified Rankin Scale(mRS),Patient-Reported Outcomes Measurement Information System-Global Health(PROMIS-10)and NIHSS.Additionally,telephone assessment at week 4 includes the simplified mRS and PROMIS-10.Safety will be evaluated by standard assessments and occurrence of adverse events over the duration of the study.Discussion Interventions that enhance recovery beyond the acute period of stroke are needed.MLC1501 has a good safety profile as well as potential to be a treatment for recovery after brain injury.The results of this study will provide objective level B evidence on the efficacy of MLC1501 on long-term recovery and safety of 24 weeks of treatment among patients with IS.
