NCT07471698尚未招募1 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Induce Pluripotent Stem Cell-derived Cardiomyocytes(HiCM-188) -Loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
Help Therapeutics1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2026年10月20日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds
研究概览
简要总结
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled. After providing informed consent, participants will be randomized 1:1 under double-blind conditions into two groups:
- CABG + HiCM-188-loaded chitosan patch group (patch size: 2×4 cm; containing 5 million cells per patch)
- CABG + blank chitosan patch group (identical in appearance but without HiCM-188 cells).
During CABG surgery, investigators will apply two HiCM-188-loaded chitosan patches onto the epicardial surface over regions of hypokinetic myocardium. The total transplanted cell dose per patient in the treatment group is 1 × 10⁷ . In the control group, eight patients will undergo identical surgical procedures with application of chitosan patches without HiCM-188 cells.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years (inclusive).
- •Willingness and ability to give written informed consent.
- •Chronic left ventricular dysfunction classified as Stage D (refractory end-stage heart failure) according to ACC staging criteria.
- •NYHA functional class III-IV despite optimized guideline-directed medical therapy for heart failure.
- •Indication for coronary artery bypass grafting (CABG), meeting one of the following anatomical criteria:
- •5.1 Class I Indications :
- •Left ventricular dysfunction with significant left main coronary artery disease;
- •Left ventricular dysfunction with "left main equivalent" disease (i.e., ≥70% stenosis in proximal LAD or proximal LCx);
- •Left ventricular dysfunction with two- or three-vessel disease including proximal LAD stenosis.
- •5.2 Class IIa Indication : Left ventricular dysfunction with substantial viable, akinetic but revascularizable myocardium, not covered by above Class I anatomical criteria.
- •Left ventricular ejection fraction (LVEF) ≤40% as measured by echocardiography or cardiac MRI within 6 months prior to enrollment (excluding measurements obtained within 1 month post-myocardial infarction).
- •Echocardiographic evidence of regional wall motion abnormalities (hypokinesis, akinesis, or presence of ventricular aneurysm).
排除标准
- •Patients meeting any of the following criteria are ineligible for study participation:
- •History of permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implantation.
- •Severe valvular heart disease or prior prosthetic valve replacement.
- •Prior percutaneous coronary intervention (PCI) with stent implantation.
- •Chronic atrial fibrillation.
- •History of sustained ventricular tachycardia or aborted sudden cardiac death.
- •Baseline estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m².
- •Hematocrit <25%.
- •Severe contrast media allergy (anaphylactic or life-threatening reaction history).
- •Coagulation disorder (INR >1.5 without therapeutic anticoagulation, platelets <50×10⁹/L, or clinically significant bleeding diathesis).
- •Known hypersensitivity to penicillin or streptomycin.
- •Contraindication to undergoing cardiac MRI (e.g., incompatible implanted devices, severe claustrophobia unresponsive to premedication).
- •History of solid organ or bone marrow transplantation.
- •Active malignancy or history of cancer within the past 5 years (except non-melanoma skin cancer or carcinoma in situ).
- •Life expectancy <1 year due to non-cardiac conditions.
- •Long-term systemic immunosuppressive therapy (e.g., corticosteroids, TNF-α inhibitors).
- •Contraindications to immunosuppressive therapy (e.g., active infection, uncontrolled diabetes, peptic ulcer disease).
- •Active infectious diseases: HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (Treponema pallidum, TP).
- •Currently participating in another interventional clinical trial.
- •Pregnant or lactating women.
研究组 & 干预措施
Control
Placebo Comparator
干预措施: Blank Chitosan Patch (Drug)
Treatment
Experimental
干预措施: HiCM-188 Chitosan Patch (Drug)
结局指标
主要结局
Proportion and frequency of patients experiencing sustained ventricular tachycardia lasting more than 30 seconds
时间窗: 1~6 Month Post-operation
Incidence of allogeneic human-derived tumor formation
时间窗: Baseline, 1, 3, 6 months post-operation
CT scan of the abdomen and pelvis
次要结局
- Change in infarct size(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in regional left ventricular function(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in regional left ventricular wall thickness(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in left ventricular end-diastolic wall thickness(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in left ventricular ejection fraction (LVEF)(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in left ventricular end-diastolic volume (LVEDV)(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in left ventricular end-systolic volume (LVESV)(Baseline, 1, 3, 6, and 12 months post-operation)
- Change in regional myocardial perfusion(Baseline, 1, 3, 6, and 12 months post-operation)
- Six-minute walk test(Baseline, 1, 3, 6, and 12 months post-operation)
- New York Heart Association (NYHA) functional classification(Baseline, 1, 3, 6, and 12 months post-operation)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ) score(Baseline, 1, 3, 6, and 12 months post-operation)
研究者
研究点 (1)
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