使用同种异体 HB-adMSCs 治疗帕金森病的临床试验（早期和中度 PD）
一项随机、双盲、单中心、2 期、异基因 HB-adMSCs 对比安慰剂治疗帕金森病患者的疗效和安全性研究
研究概览
详细说明
该试验包括长达 4 周的筛选期、32 周的治疗期和最后一次研究产品给药后 20 周的安全随访期。
该临床试验将开放招募 60 名被诊断患有帕金森病的符合条件的参与者。 患者招募将由研究团队进行，如果根据资格标准确定了符合条件的参与者，将安排筛选访问。 知情同意书将提供给研究参与者并在任何研究程序之前签署。 知情同意书将包括有关临床试验的信息以及在此过程中应考虑的某些方面。
在获得知情同意后，每个参与者都应完成以下访问。
- 访问 1 - 筛选，在这次访问期间，主要研究者将决定确定筛选的参与者是否符合条件以及是否可以安排下一次访问。 一旦主要研究者评估了筛选受试者的资格（最多 28 天），将进行随机化过程，以便为符合条件的受试者分配同种异体 HB-adMSC 或安慰剂。 随机化将仅适用于符合条件的受试者。 如果研究参与者在筛选过程中不符合纳入和排除标准，他/她将被视为筛选失败 (SF) 并且不需要随机化。
- 访问 2 - 输液 1，（基线）：此访问将用作比较参与者数据的起点。 在此访问期间，符合条件的研究参与者将接受他/她的第一次研究性产品给药或安慰剂，并在药物暴露后总共 2 小时内监测生命体征。 其他研究评估将作为这次访问的一部分完成。
- 第 3 次访问 - 输液 2：应在初始研究产品给药后约 4 周完成此访问。 其他研究评估将作为这次访问的一部分完成。
- 第 4 次访视 - 第 3 次输液：在最初的研究性产品给药后大约 8 周，应该完成这次访视。 其他研究评估将作为这次访问的一部分完成。
- 第 5 次访问 - 输注 4：在最初的研究产品给药后大约 12 周，应该完成此访问。 其他研究评估将作为这次访问的一部分完成。
- 第 6 次访问 - 输注 5：在最初的研究产品给药后大约 16 周，应该完成此访问。 其他研究评估将作为这次访问的一部分完成。
- 第 7 次访问 - 输注 6：在最初的研究产品给药后大约 20 周，应该完成这次访问。 其他研究评估将作为这次访问的一部分完成。
- 电话 - 安全跟进：在最初的研究产品给药后大约 24 周，积极的研究参与者将完成电话跟进。
- 电话 - 安全跟进：在最初的研究产品给药后大约 32 周，积极的研究参与者将完成电话跟进。
- 第 8 次访问 - 研究结束，在此最后一次访问期间（第 0 周后约 52 周），将进行一组完整的研究评估，以评估同种异体 HB-adMSC 或安慰剂给药的安全性和有效性。
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Texas
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Sugar Land、Texas、美国、77478
- Hope Biosciences Stem Cell Research Foundation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
只有满足以下所有标准，研究参与者才有资格参与本研究：
- 男性和女性参与者 45 - 80 岁。
- 在筛选访视时，研究参与者的 MDS-UPDRS 第二部分分数必须在 7 到 28 之间。
- 研究参与者在筛选访问期间的 MDS-UPDRS 第 III 部分分数必须在 20 到 57 之间。
- 研究参与者每天的卡比多巴/左旋多巴总剂量必须少于 1200 毫克。
- 研究参与者的左旋多巴当量总剂量必须低于每天 1400 毫克。
- 研究参与者必须在参与研究前至少 2 年被诊断患有早期和/或中度帕金森病。
- 研究参与者应该能够阅读、理解并提供书面同意。
- 在执行任何临床试验相关程序之前自愿签署知情同意书。
- 女性研究参与者不应怀孕或计划在研究参与期间和最后一次研究产品给药后的 6 个月内怀孕。
- 男性参与者如果他们的性伴侣可以怀孕，则应在参与研究期间和最后一次使用被调查产品后的 6 个月内使用避孕方法。
- 研究参与者能够并愿意遵守本临床试验的要求。
排除标准：
如果符合以下任何标准，研究参与者将不符合参加本临床试验的资格：
- 怀孕、哺乳。 未怀孕但未采取有效避孕措施的育龄妇女。
- 患有晚期帕金森病的研究参与者被描述为严重残疾、坐轮椅或卧床不起。
- 研究参与者患有任何活动性恶性肿瘤，包括皮肤基底癌、鳞状细胞癌或黑色素瘤的证据。
- 研究参与者已知有酒精成瘾或依赖性，或者目前有物质使用或滥用。
研究参与者有 1 种或多种重要的并发疾病（由医疗记录证实），包括：
- 糖尿病控制不佳 (PCDM) 定义为护理治疗标准不足和/或筛查访视期间餐前血糖 >130mg/dl 或餐后血糖 >200mg/dl 的病史。
- 慢性肾脏病 (CKD) 诊断病史和/或 eGFR < 59mL/min/1.73m2 的筛查结果。
- 筛选访问期间出现纽约心脏协会 (NYHA) III/IV 级心力衰竭。
- 任何不同类型心肌梗塞的任何病史，例如 ST 段抬高心肌梗塞 (STEMI) 或非 ST 段抬高心肌梗塞 (NSTEMI)、冠状动脉痉挛或不稳定型心绞痛。
- 未控制的高血压病史定义为护理治疗标准不足和/或筛选访视期间血压 > 180/120 mm/Hg。
- 遗传性血栓形成倾向的病史，近期进行过大的一般手术（筛选前 12 个月内），脊髓损伤导致的下肢瘫痪，骨盆、髋部或股骨骨折，肺癌、脑癌、淋巴癌、妇科系统癌（卵巢或子宫）或胃肠道（如胰腺或胃）。
- 帕金森病脑部手术史。
- 除 Hope Biosciences 生产的干细胞外，研究参与者在首次服用研究产品之前的 6 个月内接受过任何干细胞治疗。
- 在第一剂研究产品（COVID-19 疫苗除外）之前的 1 年内接受任何研究治疗或任何批准的研究治疗。
研究参与者在筛查期间出现实验室异常，包括以下内容：
- 白细胞计数 < 3000/mm3
- 血小板计数 < 80,000mm3
- 中性粒细胞绝对计数 < 1500/mm3
- 丙氨酸氨基转移酶 (ALT) 或天冬氨酸氨基转移酶 (AST) 10 正常上限 (ULN) x 1.5
- 研究参与者有任何其他实验室异常或医疗状况，研究者认为这些异常或医疗状况会带来安全风险或会阻止受试者完成研究。
- 研究参与者不太可能完成研究或遵守研究程序。
- 已知并发急性或慢性病毒性乙型或丙型肝炎或人类免疫缺陷病毒 (HIV) 感染的研究参与者。
- 研究参与者有先前诊断的精神疾病，研究者认为这可能会影响自我评估。
- 在研究产品首次给药前 30 天内患有任何需要用抗生素、抗病毒药或抗真菌药治疗的全身感染的研究参与者。
- 计划在研究期间或最后一次给药后 6 个月内捐献精子的男性研究参与者。 计划在研究期间或末次给药后 6 个月内捐献卵子或接受体外受精治疗的女性患者。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：同种异体 HB-adMSC。
生物/疫苗：同种异体 HB-adMSC 同种异体 HB-adMSCs 将静脉注射给符合条件的研究参与者。 其他名称：Allogeneic Hope Biosciences 脂肪来源的间充质干细胞。 |
HB-adMSCs 将静脉注射给符合条件的研究参与者。
其他名称：
无菌生理盐水 0.9%
其他名称：
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安慰剂比较：安慰剂
安慰剂将通过静脉注射给符合条件的研究参与者。 别名：无菌生理盐水 0.9% |
HB-adMSCs 将静脉注射给符合条件的研究参与者。
其他名称：
无菌生理盐水 0.9%
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
大体时间：Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
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Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
大体时间：Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The MDS-UPDRS scale consists of 4 segments.
Part II tests "Motor Aspects of Experiences of Daily Living".
Each answer to the scale is evaluated by the principal investigator during the study visit.
Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.
There are 13 items included in Part II.
Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe.
Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
大体时间：Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
大体时间：Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
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Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
大体时间：Baseline to Weeks 52
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The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
大体时间：Baseline to Weeks 52
|
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
大体时间：Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
|
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
大体时间：Baseline to Weeks 52
|
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
|
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Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
大体时间：Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
大体时间：Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
大体时间：Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
大体时间：Baseline to Weeks 52
|
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section.
The total score is achieved by summing the two individual scores.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
|
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Summary of PD Medication Dose Changes by Visit
大体时间：Baseline to Weeks 52
|
The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
|
Baseline to Weeks 52
|
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Summary of PD Medication Reinstatement by Visit
大体时间：Baseline to Weeks 52
|
The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
|
Baseline to Weeks 52
|
|
Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set
大体时间：Baseline to Week 24
|
Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Baseline to Week 24
|
|
Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
大体时间：Baseline to Week 24
|
Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Baseline to Week 24
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (mL/min/1.73
m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
大体时间：Baseline to Weeks 52
|
Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Weight - kg)
大体时间：Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Abdomen
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Cardiovascular
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - HEENT
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Lymph Node
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Musculoskeletal
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Neurological
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Respiratory
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Skin
大体时间：Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
合作者和调查者
合作者
调查人员
- 首席研究员：Djamchid Lotfi, MD、Hope Biosciences Stem Cell Research Foundation
出版物和有用的链接
一般刊物
- Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
- Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.
- Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.
- Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
- Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
- Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.
- Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.
- Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/
- Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
- Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
- Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
- Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.
- Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.
- Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.
- Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.