RecruitingPhase 3

Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart Failure (NYHA Class III-IV)

China80 participantsStarted 2026-04-30

Plain-language summary

The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Aged 18 to 75 years, regardless of gender;
✓. Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
✓. LVEF ≤ 35% as measured by cardiac MRI;
✓. Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
✓. Voluntary participation and signing of the informed consent form.

Exclusion criteria

✕. Acute viral myocarditis;
✕. Acute phase of myocardial infarction (≤ 3 months);
✕. Cardiac amyloidosis;
✕. Pericarditis;
✕. Expected to undergo heart transplantation;
✕. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
✕. Suffering from autoimmune diseases;
✕. Estimated glomerular filtration rate (eGFR) \< 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 100 U/L;

What they're measuring

6-minute walk distance (6MWD)

Timeframe: 12 months after surgery

Trial details

NCT IDNCT07496372

SponsorHELP Therapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Heart Failure trials