Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin...Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.展开更多
The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized dou...The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized double-blind placebo-controlled clinical study.We recruited patients aged 18 years or older and presenting at less than 6 h from symptom onset in 8 research centers.All the patients展开更多
背景:抵抗素在重症急性胰腺炎(severe acute pancreatitis,SAP)中的含量明显增高,抵抗素有望成为评价急性胰腺炎严重程度的新的标记物。目的:探讨中西医结合疗法对 SAP 患者血清抵抗素水平的影响。设计、场所、对象和干预措施:采用前瞻...背景:抵抗素在重症急性胰腺炎(severe acute pancreatitis,SAP)中的含量明显增高,抵抗素有望成为评价急性胰腺炎严重程度的新的标记物。目的:探讨中西医结合疗法对 SAP 患者血清抵抗素水平的影响。设计、场所、对象和干预措施:采用前瞻性随机对照研究,确定病例入选标准,病例均源干四川大学华西医院中西医结合科。所有满足入选标准的病人在签署知情同意书后进入研究程序,并按照随机号分别进入中西医结合治疗组和安慰剂对照组,治疗组13例,对照组15例。中西医结合治疗组给予西医内科基础治疗联合中医药治疗,安慰剂对照组除给予安慰剂外,其余西医内科基础治疗同中西医结合治疗组。主要结局指标:依次于入院时及入院后第1、3、5、7天抽取两组患者静脉血,观察血清抵抗素水平的变化并比较两组患者的血清抵抗素水平。结果:两组患者入院时血清抵抗素水平均明显高于正常水平,治疗组和对照组比较,差异无统计学意义(P>0.05)。治疗组第1、3、5、7天测得的抵抗素水平分别为(3.29±1.66)、(3.71±1.05)、(3.08±1.47)、(3.62±1.67)μg/L,对照组分别为(5.16±1.93)、(5.07±1.53)、(4.88±1.47)、(5.12±1.48)μg/L。治疗组血清抵抗素水平均低于对照组(P<0.05)。结论:应用中西医结合疗法能降低 SAP 患者血清抵抗素浓度,但具体作用机制有待进一步研究。展开更多
基金supported by the National Key Research and Development Program of China,No.2017YFA0105403(to LMR)the Key Research and Development Program of Guangdong Province of China,No.2019B020236002(to LMR)+4 种基金The Clinical Innovation Research Program of Guangzhou Regenerative Medicine and Health Guangdong Laboratory of China,No.2018GZR0201006(to LMR)the National Natural Science Foundation of China,Nos.81772349(to BL),31470949(to BL)the Guangzhou Science and Technology Project of China,Nos.201704020221(to LMR),201707010115(to BL)the Natural Science Foundation of Guangdong Province of China,No.2017A030313594(to BL)the Medical Scientific Research Foundation of Guangdong Province of China,No.A2018547(to MP)
文摘Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.
文摘The aim was to investigate whether using a removing blood stasis method in hyperacute intracranial hemorrhage stage can lead to hematoma enlargement and its clinical efficacy.A multicenter retrospective randomized double-blind placebo-controlled clinical study.We recruited patients aged 18 years or older and presenting at less than 6 h from symptom onset in 8 research centers.All the patients
文摘背景:抵抗素在重症急性胰腺炎(severe acute pancreatitis,SAP)中的含量明显增高,抵抗素有望成为评价急性胰腺炎严重程度的新的标记物。目的:探讨中西医结合疗法对 SAP 患者血清抵抗素水平的影响。设计、场所、对象和干预措施:采用前瞻性随机对照研究,确定病例入选标准,病例均源干四川大学华西医院中西医结合科。所有满足入选标准的病人在签署知情同意书后进入研究程序,并按照随机号分别进入中西医结合治疗组和安慰剂对照组,治疗组13例,对照组15例。中西医结合治疗组给予西医内科基础治疗联合中医药治疗,安慰剂对照组除给予安慰剂外,其余西医内科基础治疗同中西医结合治疗组。主要结局指标:依次于入院时及入院后第1、3、5、7天抽取两组患者静脉血,观察血清抵抗素水平的变化并比较两组患者的血清抵抗素水平。结果:两组患者入院时血清抵抗素水平均明显高于正常水平,治疗组和对照组比较,差异无统计学意义(P>0.05)。治疗组第1、3、5、7天测得的抵抗素水平分别为(3.29±1.66)、(3.71±1.05)、(3.08±1.47)、(3.62±1.67)μg/L,对照组分别为(5.16±1.93)、(5.07±1.53)、(4.88±1.47)、(5.12±1.48)μg/L。治疗组血清抵抗素水平均低于对照组(P<0.05)。结论:应用中西医结合疗法能降低 SAP 患者血清抵抗素浓度,但具体作用机制有待进一步研究。
