A Retrospective Phase IIa Study of Intravenous Allogeneic Non-HLA-Matched, Unrelated Donor Stem Cell, MiSaver (Myocardial Infarction Saver), Infusion for Recent Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and adverse events events
研究概览
简要总结
Despite advancements in treatments, cardiovascular diseases, especially acute myocardial infarction (AMI), remain significant health concerns. This study hypothesized that stem cells could improve left ventricular function post-AMI. An open-label trial was initiated to assess the safety and feasibility of intravenous infusion of ABO blood group-matched allogeneic umbilical cord blood stem cells (USC) prefabricated into MiSaver (Myocardial Infarction Saver) in AMI patients.
Primary Endpoint:
The primary endpoint focused on safety and adverse events over a 12-month observational period. Results showed the treatment was well-tolerated with no AEs attributed to the study product.
Secondary Outcomes:
Secondary outcomes evaluated changes in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment. A retrospective study compared eligible controls with low and middle dosage groups.
详细描述
Cardiovascular diseases, particularly acute myocardial infarction (AMI), persist as significant health concerns despite advancements in pharmaceutical and interventional treatments. Herein,investigators hypothesized stem cells could enhance left ventricular functional outcomes in patients recently afflicted by acute myocardial infarction (AMI). To investigate this hypothesis, investigators initiated an open-label, dose-escalating trial to evaluate the safety and feasibility of intravenous infusion of ABO matched allogeneic umbilical cord blood stem cells (USC), prefabricated into our study product MiSaver (Myocardial Infarction Functional Saver), in patients following recent AMI. Participants were enrolled in cohorts of five, each receiving low or middle dosages (0.5x10^7 and 1.6x10^7 cells/kg, respectively), with infusions administered 2-5 days post-AMI onset.
(Study details for low and middle dose please see study NCT04050163)
Retrospective participants meeting similar inclusion criteria of recent AMI and LVEF < 45% were identified from the study site. Twenty eligible participants were selected as controls and compared for analysis with the low and middle dosage groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 41 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 80 years
- •Diagnosed with AMI within 7 days
- •Elevated cardiac enzymes (Creatine Kinase-MB or troponin) greater than 2 times the upper limit of normal
- •Presence of regional wall motion abnormality
- •LVEF ≤ 45% on echocardiography
- •Hemodynamically stable
- •Not requiring inotropic support
- •Systolic blood pressure below 80mm Hg for less than 1 hour
- •Resting heart rate above 100 beats/min for less than 1 hour in the past 24 hours
- •Peripheral artery oxygen saturation of ≥97%
排除标准
- •Pregnancy or breastfeeding
- •Positive adventitious infections (such as HIV, hepatitis)
- •Need for coronary artery bypass surgery or anticipated further revascularization procedures during the 6-month study period
- •Severe aortic or mitral valve narrowing
- •Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
- •Inability to receive PCI examination or treatment (including New York Heart Association (NYHA) Fc.IV) due to shortness of breath
- •Malignant tumor
- •Hematopoietic dysplasia
- •Other severe organ disease
- •Less than 1 year of life expectancy
- •Chronic kidney disease with estimated Glomerular Filtration Rate (eGFR)<20 and/or on renal dialysis
研究组 & 干预措施
Low
Low dosage of MiSaver cells at 0.5x10^7 cells/kg
干预措施: MiSaver (Drug)
Middle
Middle dosage of MiSaver cells at 1.6x10^7 cells/kg
干预措施: MiSaver (Drug)
结局指标
主要结局
Safety and adverse events events
时间窗: 12 months
The primary endpoint focused on safety evaluation and is measure with number of adverse events (AEs) over a 12-month observational period.
次要结局
- Efficacy on ventricular ejection fraction (LVEF) improvement(12 months)