A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)

ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHELP Therapeutics Co., Ltd.

About this trial

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)

Eligibility criteria

Qualifiers

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;

Disqualifiers

Acute viral myocarditis;

Acute phase of myocardial infarction (≤ 3 months);

Cardiac amyloidosis;

Pericarditis;

Trial design

Treatments tested in this trial

  • HiCM-188 therapy
  • CABG surgery

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators