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

Part of paid clinical trials in Houston, Texas.

Sponsor
HELP Therapeutics Co., Ltd.
Study ID
NCT07646210
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Heart Failure
  • Ischemic Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HiCM-188 Low Dose
    Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
  • Experimental: HiCM-188 High Dose
    Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.

Primary Outcome Measure

Incidence of Serious Adverse Events [ Time Frame: Up to 12 months post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Texas Heart Institute at Baylor College of MedicineHoustonTexas77030
Emerson Perin (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
The Texas Heart Institute at Baylor College of Medicine· Houston, TX

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