A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 6-minute walk distance (6MWD)
研究概览
简要总结
The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)
详细描述
REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years, regardless of gender;
- •Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
- •LVEF ≤ 35% as measured by cardiac MRI;
- •Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
- •Voluntary participation and signing of the informed consent form.
排除标准
- •Patients considered for this trial must not meet any of the following criteria:
- •Acute viral myocarditis;
- •Acute phase of myocardial infarction (≤ 3 months);
- •Cardiac amyloidosis;
- •Pericarditis;
- •Expected to undergo heart transplantation;
- •Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
- •Suffering from autoimmune diseases;
- •Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
- •Presence of any untreated precancerous lesions or those requiring active monitoring;
- •Occurrence of malignant tumors within 5 years prior to screening;
- •Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
- •Having contraindications to the use of immunosuppressants;
- •Having contraindications to MRI;
- •Having contraindications to CABG surgery;
- •Females who are pregnant, lactating, or have a positive blood pregnancy test;
- •Plans to conceive within one year;
- •Having systemic diseases that are not effectively controlled;
- •Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.
研究组 & 干预措施
Control group
Coronary artery bypass grafting surgery
干预措施: CABG surgery (Procedure)
Experimental group
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
干预措施: HiCM-188 therapy (Biological)
Experimental group
Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery
干预措施: CABG surgery (Procedure)
结局指标
主要结局
6-minute walk distance (6MWD)
时间窗: 12 months after surgery
次要结局
- All-cause mortality and cardiovascular mortality(12 months after surgery)
- 6MWD(6 months after surgery)
- Change from baseline in the NYHA classification(12 months after surgery)
- Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)(12 months after surgery)
- Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)(12 months after surgery)
- Change from baseline in the SF-36 questionnaire(12 months after surgery)
- Myocardial blood flow as assessed by SPECT(12 months after surgery)
- Myocardial viability as assessed by SPECT(12 months after surgery)
- Left ventricular ejection fraction as assessed by MRI(12 months after surgery)
- Cardiac Volumes as assessed by MRI(12 months after surgery)
- Scar size as assessed by MRI(12 months after surgery)
- Change from baseline in NT-proBNP level(12 months after surgery)
- Tumor markers abnormally elevated compared to baseline(12 months after surgery)
- Other AEs(12 months after surgery)