NCT04954534Unknown不适用
Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® Phase-I/IIa Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change from the baseline in ADAS-Cog
研究概览
简要总结
This study is to evaluate of Exploratory Efficacy of NEUROSTEM® in Subjects who control group of NEUROSTEM® Phase-I/IIa Clinical Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have been treated with placebo in phase 1/2a clinical trial of NEUROSTEM®
- •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
- •History of stroke within 3 months prior to study enrollment
- •Severe liver disorder (equivalent to double the normal values of ALT and AST) at Visit 1
- •Severe kidney disorder (serum creatinine ≥1.5mg/dL) at Visit 1
- •Abnormal Laboratory findings at Visit 1
- •Hemoglobin < 9.5 g/dL for male and <9.0 g/dL for female
- •Total WBC Count < 3000/mm3
- •Total Bilirubin >= 3 mg/dL
- •Suspected active lung disease based on chest X-ray at Visit 1
- •Bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of < 137,000/mm3, PT ≥ 1.5 INR, or aPTT ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy)
- •Diagnosis of cancer (of any body system, including brain tumor)
- •Contraindicated for any of the tests performed during the clinical trial period (for example, MRI, CT, PET)
- •Whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above
研究组 & 干预措施
NEUROSTEM (hUCB-MSCs) - high dose
Experimental
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)
结局指标
主要结局
Change from the baseline in ADAS-Cog
时间窗: 4weeks,8weeks,12weeks,24 weeks after the first dose
The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis using an 11-point AD Assessment Scale. It has a minimum score of 0 and a maximum severity score of 70, and a higher score indicates more impairment.
次要结局
- Change in CDR-SOB(24 weeks after the first dose)
- Change from the baseline in CGA-NPI(24 weeks after the first dose)
- Change from the baseline in SIB(24 weeks after the first dose)
- Change in CIBIC-plus(24 weeks after the first dose)
- Change from the baseline in K-MMSE(korean version)(24 weeks after the first dose)
- ADAS-Cog Response Rate(The ADAS-cog response is defined as no worsening (no change or improvement on ADAS-cog score) of the ADAS-cog score at 24 weeks after the first administration compared to the baseline)
- Change from the baseline in CSF biomarkers(24 weeks after the first dose)
研究者
Duk Lyul Na
Principal Investigator
Samsung Medical Center
研究点 (1)
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