Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from the baseline in ADAS-Cog
研究概览
简要总结
A long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of NEUROSTEM® (NCT02054208), comparing NEUROSTEM and placebo groups for up to 36 months after the initial administration in patients suffering from Alzheimer's disease
详细描述
The subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of NEUROSTEM®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of NEUROSTEM®.
- •Subjects who have been treated with either NEUROSTEM® or placebo at least 12 months ago.
- •Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative)
排除标准
- •Subjects who were not enrolled in phase 1/2a clinical trial of Neurostem® for assessing safety and exploratory treatment efficacy
- •Other subjects, excluding those listed above, who were deemed unsuitable by the PI
研究组 & 干预措施
NEUROSTEM® (hUCB-MSCs)- low dose
human umbilical cord blood derived mesenchymal stem cells Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
干预措施: human umbilical cord blood derived mesenchymal stem cells (Biological)
NEUROSTEM® (hUCB-MSCs) - high dose
human umbilical cord blood derived mesenchymal stem cells High dose: 3 x 10^7 cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
干预措施: human umbilical cord blood derived mesenchymal stem cells (Biological)
Placebo
normal saline 2mL, doses separated by 4 weeks for a total of 3 doses
干预措施: Normal saline 2mL (Other)
结局指标
主要结局
Change from the baseline in ADAS-Cog
时间窗: 24 month after the first dose
Alzheimer's Disease assessment Scale-Cognitive Subscale
次要结局
- Change from the baseline in S-IADL(24 month after the first dose)
- Change from the baseline in CGA-NPI(24 month after the first dose)
- Change in Florbetaben-PET(24 month after the first dose)
- Change in CDR-SOB(24 month after the first dose)
- Change from baseline in MRI (DTI mapping)(24 month after the first dose)
- Change from the baseline in K-MMSE(24 month after the first dose)
- Change in CIBIC-plus(24 month after the first dose)
- Change in FDG-PET (CMRglc: regional cerebral metabolic rate for glucose)(24 month after the first dose)
- ADAS-Cog Response Rate(24 month after the first dose)
- Change from the baseline in CSF biomarkers(24 month after the first dose)