NCT06040476尚未招募2 期
A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 39
- 主要终点
- safety-TEAE
研究概览
简要总结
A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke
详细描述
This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject ≥18 and ≤80 years of age.
- •Subject with a confirmed diagnosis of AIS and hemiplegia
排除标准
- •Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.
研究组 & 干预措施
A group: hUCB treatment
Experimental
Human cord blood infusion
干预措施: hUCB (Biological)
结局指标
主要结局
safety-TEAE
时间窗: From screening to 48 weeks
Frequency and incidence of treatment-emergent adverse events (TEAEs).
次要结局
未报告次要终点
研究者
相似试验
尚未招募
2 期
A Study to Determine the Safety and Efficacy of TG-C in Subjects With Symptomatic Early Hip OsteoarthritisDegenerative OsteoarthritisNCT05276011Kolon TissueGene, Inc.255
Unknown
2 期
A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 InfectionCOVID-19 DiseaseNCT04969172Eli Sprecher, MD155
招募中
2 期
A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis BChronic Hepatitis BNCT06263959Fujian Akeylink Biotechnology Co., Ltd.45
已完成
2 期
A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)Palmoplantar PustulosisNCT03988335Aristea Therapeutics, Inc.35
终止
2 期
Study in Adult Asthmatic Patients With Allergic Bronchopulmonary AspergillosisAllergic Bronchopulmonary AspergillosisNCT03960606Pulmatrix Inc.7