An Exploratory, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of JTR-161 in Patients With Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] ≤1 and National Institutes of Health Stroke Scale [NIHSS] ≤1 and Barthel Index [BI] ≥95) on Day 91 in Cohort 3.
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of a single intravenous administration of JTR-161 (allogeneic stem cell product derived from the dental pulp of healthy adult humans) to patients with acute ischemic stroke.
This study is comprised of 3 cohorts and conducted in the order of Cohort 1, Cohort 2 and Cohort 3.
Cohort 1 Arm-1: JTR-161, 1 × 10^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
The Data and Safety Monitoring Board (DSMB) and the Sponsor will decide whether Cohort 2 can be initiated or not.
Cohort 2 Arm-1: JTR-161, 3 × 10^8 cells/subject, 6 subjects Arm-2: Placebo, 2 subjects
DSMB and the Sponsor will decide whether Cohort 3 can be initiated or not and the dose of JTR-161 in Cohort 3.
Cohort 3 Arm-1: JTR-161, 1 × 10^8 cells/subject or 3 × 10^8 cells/subject, 30 subjects Arm-2: Placebo, 30 subjects
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)
盲法说明
Some care providers who involved in the preparation or administration of dosing solutions are unblinded.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have ischemic strokes in the anterior circulation
- •Patients whose mRS is 0 or 1 prior to the onset of ischemic stroke
- •Patients whose NIHSS score of ≥5 to ≤20 at screening
- •Patients who can be administered dosing solutions within 48 h of stroke onset
排除标准
- •Patients who have new ischemic lesion in the cerebellum or brainstem
- •Patients whose consciousness level drops severely
- •Patients whose infarct area is widespread
- •Patients who have a clinically significant hemorrhagic transformation
- •Patients who had seizures after onset of ischemic stroke
- •Patients who have medical history of a neurological event such as stroke or clinically significant head trauma within 180 days prior to giving informed consent
- •Patients who have poor blood pressure control
- •Patients who have poor glycaemic control
- •Patients who have one of the following complications
- •Severe liver dysfunction
- •Severe kidney dysfunction
- •Severe heart failure
- •Severe pulmonary dysfunction
- •Patients who have severe infections
- •Patients who have any neurological disorder affecting informed consent or study assessments
- •Patients who have the malignant tumor, or medical history of malignant tumor within 2 years prior to the onset of ischemic stroke
- •Patients who have a contraindication for MRI
- •Patients who have thrombocytopenia
- •Patients who have medical history of allergy to products derived from human tissues, bovine or porcine
- •Patients who have medical history of allergy to streptomycin
- •Patients who have undergone splenectomy in the past
- •Patients who have a possibility of transient ischemic attack
- •Patients who are scheduled to undergo revascularization (carotid endarterectomy, stent placement etc.)
结局指标
主要结局
The percentage of patients who achieved Excellent outcome (modified Rankin Scale [mRS] ≤1 and National Institutes of Health Stroke Scale [NIHSS] ≤1 and Barthel Index [BI] ≥95) on Day 91 in Cohort 3.
时间窗: 91 days
次要结局
- Percentage of patients who achieved excellent outcome (mRS ≤ 1, NIHSS ≤ 1, and BI ≥ 95)(91 days)
- Percentage of patients who achieved BI ≥ 95(366 days)
- Percentage of patients who achieved mRS ≤ 1 or mRS ≤ 2(366 days)
- Percentage of patients who achieved NIHSS ≤ 1, who achieved improvement of ≥ 75%, and who achieved improvement of ≥ 10 points(91 days)
- Incidence of Adverse events (signs and symptoms)(366 days)
- Percentage of patients who showed overall improvement (mRS ≤ 2, NIHSS improvement of ≥ 75%, and BI ≥ 95)(91 days)
- Changes in Laboratory tests (hematology, blood chemistry, blood coagulation test, urinalysis)(366 days)
- Changes in findings of imaging examination by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).(31 days)
- Changes in Vital signs (blood pressure [systolic/diastolic], pulse rate, body temperature)(366 days)
- Changes in EQ-5D-5L scores(366 days)
- Changes in Oxygen saturation (SpO2)(366 days)