Clinical Trial

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

Not Yet Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-09.
Trial Details
NCT Number NCT07646210
Lead Sponsor HELP Therapeutics Co., Ltd.
Conditions Advanced Heart Failure, Ischemic Heart Failure
Enrollment 12 participants
Start Date 2026-09
Primary Completion 2028-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-29