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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HiCM-188 therapy

    Biological/Vaccine

    Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery

  • CABG surgery

    Procedure/Surgery

    Conventional coronary artery bypass grafting (CABG) surgery

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Experimental groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

6-minute walk distance (6MWD)

Time frame
12 months after surgery

Secondary outcomes

1

All-cause mortality and cardiovascular mortality

Time frame
12 months after surgery
2

6MWD

Time frame
6 months after surgery
3

Change from baseline in the NYHA classification

Time frame
12 months after surgery
4

Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)

Time frame
12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HELP Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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