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HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery

2026年11月5日 更新者：HELP Therapeutics, Inc.

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

12

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Texas
      • Houston、Texas、美国、77030
        • The Texas Heart Institute at Baylor College of Medicine
        • 首席研究员：
          • Emerson Perin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：HiCM-188 Cells

HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
实验性的：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.
药品：HiCM-188 Cells

HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Serious Adverse Events
大体时间：Up to 12 months post-transplant

Incidence of serious adverse events (SAEs) at 12 months post-transplant
Up to 12 months post-transplant

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
大体时间：Baseline, 6 months, and 12 months

Change from baseline in left ventricular ejection fraction (LVEF, %) assessed by cardiac magnetic resonance imaging (MRI). Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Baseline, 6 months, and 12 months
Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI
大体时间：Baseline, 6 months, and 12 months

Change from baseline in left ventricular end-diastolic volume (LVEDV, mL) assessed by cardiac MRI. Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Baseline, 6 months, and 12 months
Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI
大体时间：Baseline, 6 months, and 12 months

Change from baseline in left ventricular end-systolic volume (LVESV, mL) assessed by cardiac MRI. Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Baseline, 6 months, and 12 months
Change From Baseline in Infarct Size by Cardiac MRI
大体时间：Baseline, 6 months, and 12 months

Change from baseline in myocardial infarct size assessed by cardiac MRI.
Baseline, 6 months, and 12 months
Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT
大体时间：Baseline, 6 months, and 12 months

Change from baseline in myocardial tissue perfusion assessed by positron emission tomography/computed tomography (PET/CT) or single-photon emission computed tomography (SPECT).
Baseline, 6 months, and 12 months
Change From Baseline in 6-Minute Walk Distance
大体时间：Baseline, 6 months, and 12 months

Change from baseline in exercise capacity as assessed by the 6-minute walk distance (6MWD). The 6-Minute Walk Distance is measured as the distance walked in 6 minutes, with longer distances reflecting better functional exercise capacity.
Baseline, 6 months, and 12 months
Change From Baseline in New York Heart Association Functional Classification
大体时间：Baseline, 6 months, and 12 months

Change from baseline in New York Heart Association (NYHA) functional classification. The New York Heart Association Functional Classification ranges from Class I to Class IV, with higher classes reflecting more severe limitation of physical activity and worse heart failure symptoms.
Baseline, 6 months, and 12 months
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
大体时间：Baseline, 6 months, and 12 months

Change from baseline in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The Minnesota Living With Heart Failure Questionnaire score ranges from 0 to 105, with higher scores reflecting worse heart failure-related quality of life.
Baseline, 6 months, and 12 months
Incidence of Major Adverse Cardiac Events
大体时间：Up to 12 months post-transplant

Incidence of major adverse cardiac events (MACE) during the study follow-up period.
Up to 12 months post-transplant

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

HELP Therapeutics, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年2月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2029年2月1日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HICM188H1101

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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