A Phase 1/2A Study of the Safety and Efficacy of Modified Stromal Cells (SB623) in Patients With Stable Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- SanBio, Inc.
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary purpose of the clinical study is to determine the safety of a modified stem cell SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke patients must be between 6 and 60 months after their stroke, and with only this one prior stroke, and with no further improvement from physical therapy.
详细描述
Chronic, stable stroke patients have no existing alternative treatments after rehabilitation therapy. SB623, a modified stem cell preparation, has been shown to improve motor function when administered in animal models of stable stroke. Safety studies in animals have shown no adverse events attributed to SB623. Patients who meet the entry criteria for this study will have regular examinations, radiological evaluations (CT, MRI, PET), and be followed for two years. Regular neurological evaluations will also be done using standard questionnaires, with occasional video recording if improvements are evident. Key entry criteria for this study, in addition to 6-60 months post-ischemic stroke, include moderately severe symptoms--e.g., difficulty standing or walking, and/or difficulty using arms or hands, and/or speech impediments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of one completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement
- •Between 6 and 60 months post-stroke, and having a motor neurological deficit
- •No significant further improvement with physical therapy/rehabilitation
- •Able and willing to undergo computed tomography (CT), magnetic resonance imaging (MRI), and positron-emission tomography (PET) scans of the head
排除标准
- •History of more than 1 symptomatic stroke
- •History of seizures
- •History or presence of any other major neurological disease
- •Myocardial infarction within prior 6 mos.
- •Known presence of any malignancy except squamous or basal cell carcinoma of the skin
- •Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of study entry
- •Contraindications to head CT, MRI, or PET
- •Pregnant or lactating
结局指标
主要结局
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
时间窗: 6 months
Number of subjects with TEAEs by maximum severity. The severity of all AEs was assessed by the Investigator using the World Health Organization (WHO) Toxicity Scale. For abnormalities not found elsewhere in the WHO table, the following scale was used to assign severity: Mild: Transient mild discomfort; no limitation in activity; no medical intervention/therapy required. Moderate: Mild-to-moderate limitation in activity; some assistance may be need. No or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required; hospitalization or prolongation of current hospitalization possible. Life-threatening: Extreme limitation in activity, significant assistance required; significant medial intervention/therapy required; hospitalization or prolongation of current hospitalization or hospice care probable.
次要结局
- Change in the European Stroke Scale (ESS) Total Score From Baseline at Month 6(6 months)
- Change in the Modified Rankin Scale (mRS) Response From Baseline at Month 6(6 months)
- Change in the Fugl-Meyer Lower Extremity Motor Function Total Score From Baseline at Month 6(6 months)
- Change in the Fugl-Meyer Total Score From Baseline at Month 6(6 months)
- Change in the National Institutes of Health Stroke Scale (NIHSS) Motor Function Total Score From Baseline at Month 6(6 months)
- Change in the European Stroke Scale (ESS) Motor Function Total Score From Baseline at Month 6(6 months)
- Change in the Fugl-Meyer Motor Total Score (FMMS) Total Score From Baseline at Month 6(6 months)
- Change in the National Institutes of Health Stroke Scale (NIHSS) Total Score From Baseline at Month 6(6 months)
- Change in the Fugl-Meyer Upper Extremity Motor Function Total Score From Baseline at Month 6(6 months)