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NOT YET RECRUITING
NCT07646210
PHASE1/PHASE2

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

Sponsor: HELP Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-09

Completion Date

2028-05

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

HiCM-188 Cells

HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

Locations (1)

The Texas Heart Institute at Baylor College of Medicine

Houston, Texas, United States