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)

Phase 3 Recruiting 80 enrolled HELP Therapeutics Co., Ltd.

RandomizedParallel-groupSingle-blindTreatment

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)

Timeline

Start: 2026-04-30
Primary completion: 2027-06-30
Completion: 2027-08-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HiCM-188	Cell therapy	1.5e+08 cells	Other

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)

Summary

Timeline

Drugs

Indications