A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery.
Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.
详细描述
This is a Phase I/IIa, open-label, dose-escalation study of HiCM-188 in adult participants with advanced heart failure. HiCM-188 is an investigational cell therapy product consisting of allogeneic human iPSC-derived cardiomyocytes intended for intramyocardial administration.
Eligible participants will receive HiCM-188 during coronary artery bypass grafting (CABG) surgery. The study uses a 3+3 dose-escalation design to evaluate two dose levels of HiCM-188: 0.5 × 10^8 cells and 1.5 × 10^8 cells. The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188. Secondary objectives include evaluation of preliminary efficacy based on cardiac function, myocardial perfusion, exercise capacity, NYHA functional classification, quality of life, and major adverse cardiac events.
Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Able to sign informed consent and comply with the study protocol
- •18 to 75 years old at the time of signing informed consent
- •Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)
- •Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa
- •Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- •Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- •Other criteria apply. Please contact the investigator for more information.
排除标准
- •Viral myocarditis
- •Amyloidosis
- •Pericardial disorders or pericarditis
- •Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
- •Primary significant organic valvular heart disease, with specified dimensions
- •Untreated congenital heart disease
- •Complete atrioventricular (AV) conduction block
- •History of left ventricular assist device surgery
- •Other criteria apply. Please contact the investigator for more information.
研究组 & 干预措施
HiCM-188 Low Dose
Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
干预措施: HiCM-188 Cells (Drug)
HiCM-188 High Dose
Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
干预措施: HiCM-188 Cells (Drug)
结局指标
主要结局
未指定
次要结局
- Change From Baseline in 6-Minute Walk Distance(Baseline, 6 months, and 12 months)
- Change From Baseline in New York Heart Association Functional Classification(Baseline, 6 months, and 12 months)
- Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score(Baseline, 6 months, and 12 months)