A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-S in Patients With Ischemic Stroke in the Recovery Phase
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment motor score
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.
详细描述
This study aims to further evaluate the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of stroke. Eligible participants will be randomized to receive either intravenous infusions of hUC-MSCs or a matching placebo. Over the 12-month study period, participants will be required to attend regular clinic visits for comprehensive neurological assessments, including the Fugl-Meyer Assessment (FMA), Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Mini-Mental State Examination (MMSE), as well as vascular imaging studies and biomarker analyses. Additionally, participants (or their caregivers, where applicable) will be instructed to consistently document neurological symptoms, functional activities, and the use of any rehabilitation medications or assistive devices.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤70 years, regardless of gender.
- •14 to 90 days after ischemic stroke.
- •Clinical diagnosis of anterior circulation ischemic stroke.
- •National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.
- •It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.
排除标准
- •People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
- •Intracranial hemorrhagic conditions.
- •Pre-stroke mRS score >
- •Severe cardiovascular disease.
- •Severe pulmonary diseases.
研究组 & 干预措施
MSCs treatment
Intravenous injection of mesenchymal stem cells
干预措施: IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells) (Drug)
Placebo
Intravenous injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Fugl-Meyer Assessment motor score
时间窗: 12 months
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based scale used to evaluate motor impairment. Its motor score, which ranges from 0 to 100, serves as a key parameter for quantifying motor recovery, where a higher score indicates better motor function.
次要结局
- Modified Rankin Scale(12 months)
- National Institutes of Health Stroke Scale(12 months)
- Barthel Index(12 months)
- Mini-Mental State Examination(12 months)