NCT06866600尚未招募1 期
Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure
Help Therapeutics1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 6-minute walk test
研究概览
简要总结
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
- •Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
- •Diagnosed with end-stage heart failure.
- •Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
- •Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
- •Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.
- •Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.
- •Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.
- •For patients enrolled in the LVAD implantation group, the following additional criteria must be met:
- •Definitive indication for LVAD implantation due to end-stage heart failure.
- •Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
- •Absence of significant contraindications for LVAD surgery.
排除标准
- •History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
- •Severe valvular heart disease.
- •Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
- •Non-ischemic cardiomyopathy or acute viral myocarditis.
- •Acute cerebrovascular event within 1 month prior to screening.
- •History of malignancy within 5 years prior to screening.
- •Autoimmune disease or chronic use of immunosuppressive agents.
- •History of organ transplantation.
- •Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
- •Malignant ventricular arrhythmia.
- •Contraindications for CABG surgery.
- •Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody.
- •Inability to undergo cardiac MRI or PET/CT imaging.
- •Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
- •Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.
- •Participation in another clinical trial within 3 months prior to screening.
- •Pregnancy, lactation, or positive pregnancy test in female patients.
- •Any other condition deemed by the investigator to render the patient unsuitable for trial participation.
研究组 & 干预措施
Control group
Sham Comparator
CABG combined with saline or LVAD combined with saline
干预措施: CABG/LVAD+Saline (Other)
Low Dose Group
Experimental
CABG combined with 0.5×10^8 iPSC-CMs
干预措施: low dose CABG+iPSC-CMs (Biological)
High dose group
Experimental
CABG combined with 1.5×10^8 iPSC-CMs or LVAD combined with 1.5×10^8 iPSC-CMs
干预措施: High dose CABG/LVAD+iPSC-CMs (Biological)
结局指标
主要结局
6-minute walk test
时间窗: baseline, 1, 3, 6, 12 months post-operation
Major Adverse Cardiovascular Events
时间窗: From enrollment to the end of study at 12 months
The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).
Survival rate
时间窗: From enrollment to the end of study at 12 months
次要结局
- Left ventricular ejection fraction(baseline, 1, 3, 6, 12 months post-operation)
- Removal rate of LVAD(From enrollment to the end of study at 12 months)
- Cardiac magnetic resonance detection index(baseline, 1, 3, 6, 12 months post-operation)
- BNP(baseline, 1, 3, 6, 12 months post-operation)
- SF-36(baseline, 1, 3, 6, 12 months post-operation)
- KCCQ(baseline, 1, 3, 6, 12 months post-operation)
研究者
研究点 (1)
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