A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 33
- 主要终点
- Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
研究概览
简要总结
The objective of the present study is to establish the safety and efficacy of Prochymal® following first acute myocardial infarction.
详细描述
The standard of care treatment for acute myocardial infarction (AMI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. However, because salvaging the viable myocardium is dependent on early reperfusion, only a minority of participants will reach the hospital within the time-window for myocardial rescue. Thus, even if the participant manages their tobacco use, hypertension, lipid levels, diabetes, weight and exercise, many participants will go on to develop Congestive Heart Failure (CHF). Though the medical management for CHF may improve symptoms and slow disease progression, such treatment cannot restore a functioning myocardium. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit. The characteristics and biologic activity of Prochymal®, along with a good safety profile in human trials to date, suggest that Prochymal® may be a good candidate for addressing this unmet medical need.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 21 and 85 years old, inclusive
- •First heart attack within 7 days prior to randomization and drug infusion
- •Baseline left ventricular ejection fraction (LVEF) 20-45%
- •Hemodynamically stable within 24 hours prior to randomization
- •Adequate pulmonary function
排除标准
- •Previous medical history of heart attack, heart failure, significant valvular heart disease, aortic dissection
- •Pacemaker or other device
- •Pregnant, breast-feeding, or intends to become pregnant during the study
- •Allergy to cow or pig derived products
- •Evidence of active malignancy or prior history of active malignancy
- •Major surgical procedure or major trauma within the past 14 days
- •Autoimmune disease (e.g., Lupus, Multiple Sclerosis)
- •Any medical condition, which in the opinion of the Investigator, renders participation unsuitable
- •Undergone pharmacologic cardioversion or external defibrillation within 24 hours of randomization.
- •Experienced cardiac arrest more than 36 hours after presentation to site or within 24 hours of randomization.
研究组 & 干预措施
Prochymal®
Participants will receive Prochymal® single intravenous (IV) infusion at a dose of 200 x 10^6 human mesenchymal stem cells (hMSC), reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.
干预措施: Prochymal® (Drug)
Placebo
Participants will receive Prochymal® placebo-matching single IV infusion at a dose of of 200 x 10^6 hMSC, reconstituted in 80 mL, delivered at a rate of 2 mL/min, with a maximum rate of 5.0 x 10^6 hMSC/minute, and the participants will be followed for 24 months and remain in the study for up to 60 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Cardiac Magnetic Resonance (CMR) imaging-determined End Systolic Volume (ESV) at Month 3
时间窗: Baseline, Month 3
次要结局
- Infarct Size(3 and 6 months)
- Left Ventricular Ejection Fraction(3 and 6 months)
- Left Ventricular End Diastolic Volume(3 and 6 months)
- Left Ventricular End Systolic Volume(6 months)
- Overall Survival(60 months)
- New York Heart Association (NYHA) Congestive Heart Failure Classification Status(6, 12, 24, and 60 months)
- Maximal Symptom-limited Exercise Test (Treadmill)(6 and 12 months)
- Number of Participants with Ventricular Arrhythmias(3 and 6 months)
- Duke Activity Status Index (DASI) Assessment(6, 12, and 24 months)
- Number of Participants with Major Adverse Cardiac Events (MACE)(6, 12, 24, and 60 months)
- Number of Participants with Adverse Events(3,6,12,24,60 months)