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NCT Number: NCT07646210

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

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.

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Key information

Conditions

Advanced Heart Failure Ischemic Heart Failure

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Texas Heart Institute at Baylor College of Medicine

Houston, Texas, 77030, United States

Location contact

Emerson Perin

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HiCM-188 Cells

Drug

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

Primary outcomes

  1. Incidence of Serious Adverse Events

    Time frame: Up to 12 months post-transplant

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

Secondary outcomes

  1. Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI

    Time frame: 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.

  2. Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI

    Time frame: 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.

  3. Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI

    Time frame: 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.

  4. Change From Baseline in Infarct Size by Cardiac MRI

    Time frame: Baseline, 6 months, and 12 months

    Change from baseline in myocardial infarct size assessed by cardiac MRI.

  5. Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT

    Time frame: 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).

  6. Change From Baseline in 6-Minute Walk Distance

    Time frame: 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.

  7. Change From Baseline in New York Heart Association Functional Classification

    Time frame: 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.

  8. Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score

    Time frame: 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.

  9. Incidence of Major Adverse Cardiac Events

    Time frame: Up to 12 months post-transplant

    Incidence of major adverse cardiac events (MACE) during the study follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Zhang

CONTACT

[email protected]

+1 650 504 5586

Sponsors and collaborators

Lead sponsor

HELP Therapeutics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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