Sequential Treatment of Extra-Corporeal Shock Wave Combined With aUtologous Bone marRow Mesenchymal Stem Cells in Patients With ischEmic Heart Disease : the S-CURE Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline to 6 months follow-up in infarct size.
研究概览
简要总结
This study is designed to evaluate the efficacy, safety and tolerability of autologous bone marrow derived mesenchymal stem cells compared to placebo (sham operation) when administered via percutaneous coronary infusion to patients with ischemic heart disease, who are screened by D-SPECT and have pretreated with 3-month cardiac shock wave therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant, non-lactating females;
- •Chronic ischemic heart failure, previous anterior myocardial infarction > 3months;
- •Viable myocardium is detected by D-SPECT;
- •LVEF < 50% measured by echocardiography or NYHA II-IV;
- •No planed reasonable revascularization procedures;
- •At least 30 days standard medical therapy for heart failure before screening;
- •Worsening heart failure within 6 months or have a NT-proBNP ≥1000 pg/mL or BNP ≥200 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤425 meters at screening;
- •Written informed consent.
排除标准
- •Ventricular thrombus;
- •Myocardial infarction, TIA or stroke < 3 months;
- •CRT/CRT-D implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, heart failure-related device interventions, or cardiac shunt implantation;
- •Active infection or fever;
- •Chronic inflammatory disease;
- •HIV infection or active hepatitis;
- •Hemoglobin A1c (HbA1c) ≥ 9% at screening;
- •Body mass index (BMI) ≥ 40 kg/m2 at screening;
- •Chronic kidney disease (CKD) requiring dialysis (Stage 5) or estimated creatinine clearance < 30 mL/min/1.73㎡ at screening;
- •Allergies to any equine, porcine, or bovine products;
- •Abnormal laboratory values at screening：Platelets < 50,000 μL;Hemoglobin < 9.0 g/dL; Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 3 times the upper limit of normal (ULN);
- •Mental retardation;
- •Participation in other clinical study < 1 month.
研究组 & 干预措施
CSWT+BMMSCs
Patients in CSWT+BMMSCs group will receive a 3-month cardiac shock wave therapy and then a total of 1 million/kg BMMSCs will be infused using the stop-flow technique through an over-the-wire balloon catheter positioned in a coronary artery or bypass graft supplying the targeting viable myocardium.
干预措施: CSWT+BMMSCs (Combination Product)
CSWT+Sham operation
Placebo group will receive a 3-month CSWT and a sham procedure.
干预措施: CSWT+Sham operation (Device)
结局指标
主要结局
Change from baseline to 6 months follow-up in infarct size.
时间窗: 6 months
The primary outcome will evaluate the change in infarct size as measured by D-SPECT.
Change from baseline to 6 months follow-up in LVEF.
时间窗: 6 months
The primary outcome will evaluate the change in left ventricular function as measured by echocardiography and D-SPECT for left ventricular ejection fraction (LVEF).
次要结局
- Change from baseline to 6 months follow-up in exercise time increment.(6 months)
- Change from baseline to 6 months follow-up in exercise distance increment(6 months)
- Change from baseline to 6 months follow-up in NYHA Classification.(6 months)
- Change from baseline to 6 months follow-up in quality of life measured by MLHFQ(6 months)
- Percent of patients with adverse events.(6 months)
- Change from baseline to 6 months follow-up in quality of life measured by KCCQ(6 months)
研究者
Ya-Wei Xu
Professor
Shanghai 10th People's Hospital