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NCT Number: NCT06340048

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Willingness and ability to give written informed consent
  • Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
  • LVEF<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI
  • Patients have indications for Coronary Artery Bypass Grafting

Exclusion criteria

  • Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT)
  • Diagnosed with malignancy within 5 years
  • Autoimmune disease
  • Recipients of organ transplant.
  • Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion).
  • Severe ventricular arrhythmia
  • Contraindication to CABG surgery
  • Contraindication to cardiac MRI or PET/CT scan.
  • Contraindication to immunosuppressants
  • Participation in another clinical trial within 3 months prior to screening
  • Pregnancy, lactation, or a positive serum pregnancy test
  • Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial

Treatment and study plan

HiCM-188 therapy

Drug

Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery

Primary outcomes

  1. The incidence of major Serious Adverse Events (SAE)

    Time frame: Within the first month after surgery

    The incidence of major Serious Adverse Events (SAE) within the first month after surgery, including pericardial tamponade, nonfatal myocardial infarction, stroke, and all-cause death

Secondary outcomes

  1. Grade 4 or above arrhythmias Related to HiCM-188 Cell Therapy

    Time frame: Within the first month after surgery

    Grade 4 or above arrhythmias associated with the HiCM-188 therapy within the first month after surgery

  2. The incidence of tumor

    Time frame: 12 months after surgery

    assessed by PET whole-body imaging at baseline and 12 months after HiCM-188 therapy

  3. Left ventricular geometry as assessed by cardiac magnetic resonance imaging (MRI)

    Time frame: Baseline, 6 and 12 months after surgery

    Left ventricular wall thickness, interventricular septum thickness

  4. Size of myocardial infarction as assessed by MRI

    Time frame: Baseline, 6 and 12 months after surgery

    Size of myocardial infarction

  5. Ventricular wall motion as assessed by MRI

    Time frame: Baseline, 6 and 12 months after surgery

    Ventricular wall motion

  6. Left ventricular ejection fraction as assessed by MRI

    Time frame: Baseline, 6 and 12 months after surgery

    Left ventricular ejection fraction

  7. Cardiac Volumes as assessed by MRI

    Time frame: Baseline, 6 and 12 months after surgery

    Left ventricular end-diastolic volume (LVEDV), Left ventricular end-systolic volume (LVESV) and Stroke Volume (SV)

  8. Cardiac output (CO) as assessed by MRI

    Time frame: Baseline, 6 and 12 months after surgery

    Cardiac output (CO)

  9. End-diastolic myocardial mass as assessed by MRI

    Time frame: Baseline, 6 and 12 months after surgery

    End-diastolic myocardial mass

  10. Left ventricular ejection fraction (LVEF) as assessed by Echocardiography

    Time frame: Baseline, 6 and 12 months after surgery

    Left ventricular ejection fraction

  11. Fractional shortening (FS) as assessed by Echocardiography

    Time frame: Baseline, 6 and 12 months after surgery

    Fractional shortening

  12. Left ventricular dimensions as assessed by Echocardiography

    Time frame: Baseline, 6 and 12 months after surgery

    Left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter(LVESD)and left atrial diameter

  13. Cardiac Volumes as assessed by Echocardiography

    Time frame: Baseline, 6 and 12 months after surgery

    Left ventricular end- diastolic volume (LVEDV) and Left ventricular end-systolic volume(LVESV)

  14. Mitral valve inflow spectrum(E/A) as assessed by Echocardiography

    Time frame: Baseline, 6 and 12 months after surgery

    Mitral valve inflow spectrum (E/A)

  15. Longitudinal strain as assessed by Echocardiography

    Time frame: Baseline, 6 and 12 months after surgery

    Longitudinal strain

  16. Myocardial viability as assessed by SPECT

    Time frame: Baseline, 6 and 12 months after surgery

    Myocardial viability

  17. Myocardial blood flow as assessed by SPECT

    Time frame: Baseline, 6 and 12 months after surgery

    Myocardial blood flow

  18. NT-proBNP Levels

    Time frame: Baseline, 6 and 12 months after surgery

    The changes of NT-proBNP Levels

  19. 6-minute walking distance

    Time frame: Baseline, 6 and 12 months after surgery

    The changes of 6-minute walking distance at 6M and 12M after HiCM-188 therapy

  20. New York Heart Association (NYHA) functional classification

    Time frame: Baseline, 6 and 12 months after surgery

    The changes of New York Heart Association (NYHA) functional classification at 6M and 12M after HiCM-188 therapy

  21. Changes of Quality of Life (QoL) as assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: Baseline, 6 and 12 months after surgery

    The MLHFQ is a self-administered disease-specific outcome measure instrument for patients with heart failure (HF), comprising 21 items rated on Likert scales, representing different degrees of impact of HF on QoL.

    The MLHFQ scores are on a range of 0-105, in which higher scores reflect better health status.

  22. Changes of Quality of Life(QOL) as assessed by 36-Item Short Form Survey (SF-36)

    Time frame: Baseline, 6 and 12 months after surgery

    The 36-Item Short Form Survey(SF-36) is a self-administered outcome measure instrument that comprises 36 items grouped into 8 dimensions: limitations in physical activities because of health problems, limitations in social activities because of physical or emotional problems, limitations in usual role activities because of physical health problems, bodily pain, general mental health, limitations in usual role activities because of emotional problems, vitality, general health perceptions.

    The SF-36 scores are on a range of 0-100, in which higher scores reflect better health status.

Sponsors and collaborators

Lead sponsor

HELP Therapeutics Co., Ltd.

Industry

Collaborators

  • TEDA International Cardiovascular Hospital

Registry information

Official study title

Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure

Acronym: HEAL-AHF

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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