Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure

Last updated: February 6, 2026
Sponsor: Help Therapeutics
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

HiCM-188 therapy

Clinical Study ID

NCT06340048
XC Liu
  • Ages > 18
  • All Genders

Study Summary

The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Willingness and ability to give written informed consent

  3. Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI)revealed infarcted myocardium in the left anterior descending branch (LAD) coronaryartery supply area

  4. LVEF<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI

  5. Patients have indications for Coronary Artery Bypass Grafting

Exclusion

Exclusion Criteria:

  1. Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiacresynchronization therapy device (CRT)

  2. Diagnosed with malignancy within 5 years

  3. Autoimmune disease

  4. Recipients of organ transplant.

  5. Patients undergoing other surgical operations (excluding resection of ventricularaneurysm and left atrial appendage excision/occlusion).

  6. Severe ventricular arrhythmia

  7. Contraindication to CABG surgery

  8. Contraindication to cardiac MRI or PET/CT scan.

  9. Contraindication to immunosuppressants

  10. Participation in another clinical trial within 3 months prior to screening

  11. Pregnancy, lactation, or a positive serum pregnancy test

  12. Any other condition considered by the investigator to be inappropriate for inclusionin this clinical trial

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: HiCM-188 therapy
Phase: 1/2
Study Start date:
September 05, 2023
Estimated Completion Date:
May 10, 2027

Study Description

This is a single center, open-label, three-group dose-escalation (phase I) study followed by dose-extension (phase IIa) study in up to 36 severe ischemic heart failure patients. It is estimated that up to 18 phase I patients will be received HiCM-188 intramyocardial injection during CABG surgery. The maximum number of subjects after dose escalation and dose extension studies in each dose group is 12. All the subjects need take immunosuppressant after transplantation.

Connect with a study center

  • TEDA International Cardiovascular Hospital

    Tianjin, Tianjin 300457
    China

    Site Not Available

  • TEDA International Cardiovascular Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300457
    China

    Site Not Available

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