A Phase 1/2 Randomized Study to Evaluate the Safety and Tolerability of Intracarotid Artery Administration of NCS-01 in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of participants with change in Electrocardiography (ECG)
研究概览
简要总结
This is an initial Phase1/2 dose-finding, randomized, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 48 hours of stroke onset. This study will be conducted in 2 stages.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, age 18 to 85 years inclusive
- •Clinical evidence of acute ischemic unilateral cerebral infarction
- •- Evidence of neurologic deficits as defined by NIHSS 6 to 18 or NIHSS < 6 with Fugl-Meyer upper extremity subtotal 6 to 40 inclusive
- •Women of child bearing potential who agrees to take acceptable birth control as described in the ICF
- •Provide written informed consent before participation, either by patient or a legal representative
排除标准
- •Progressive neurologic deficit
- •An inability to undergo an MRI scan
- •Any malignancies within the last 5 years
- •Previous organ transplantation
- •Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months
- •Women of childbearing potential with a positive pregnancy test
- •Already dependent in activities of daily living (Rankin scale 3 or more) before the present acute stroke
- •Known hypersensitivity, allergy or intolerance to the similar biologic interventions
- •Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives judged by Investigator based on medical history, physical examination, laboratory tests and/or ECG
研究组 & 干预措施
NCS-01
human bone marrow derived cells
干预措施: NCS-01 (Biological)
sham
sham procedure
干预措施: NCS-01 (Biological)
结局指标
主要结局
Number of participants with change in Electrocardiography (ECG)
时间窗: multiple times for the duration of the study (baseline through Month 12)
ECG (standard digital 12-lead in singlicate)
Number of participants with change in clinical laboratory evaluations
时间窗: multiple times for the duration of the study (baseline through Month 12)
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
National Institutes of Health Stroke Scale (NIHSS)
时间窗: 1 hour, 3 hours, and 6 hours post infusion
Change from baseline in the NIHSS NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Number of participants with change in in physical examination
时间窗: multiple times from baseline through Month 12
physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
时间窗: multiple times for the duration of the study (baseline through Month 12)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
次要结局
- Number of participants with change in Cytokine panel (IL-1, 6, 8, etc.)(multiple times for the duration of the study (baseline through Month 12))
- Number of participants with change in MRI(multiple times for the duration of the study (baseline through Month 12))
- Number of participants with change in Barthel Index(multiple times for the duration of the study (baseline through Month 12))
- Number of participants with change in Modified Rankin Scale (mRS)(multiple times for the duration of the study (baseline through Month 12))