AzTrials
AzTrials

Heart FailurePhase 1/2HEAL-AHFNCT06340048

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

A Phase 1/2 study testing HiCM-188 therapy in people with Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
HiCM-188 therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
5 Sep 2023to 10 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • TEDA International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300457

Other trials in China

About this study

Official title: Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes 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.

Read the detailed 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.

Conditions
Heart Failure
Being tested
HiCM-188 therapy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HiCM-188 therapyDrug

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

Study groups in NCT06340048
Study groupRoleWhat they receive
HiCM-188 Low dose therapyExperimentalIntramyocardial injection of HiCM-188 (50 million) during CABG surgery.
Receives: Drug: HiCM-188 therapy
HiCM-188 Medium dose therapyExperimentalIntramyocardial injection of HiCM-188 (150 million) during CABG surgery.
Receives: Drug: HiCM-188 therapy
HiCM-188 High dose therapyExperimentalIntramyocardial injection of HiCM-188 (450 million) during CABG surgery.
Receives: Drug: HiCM-188 therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: Within the first month after surgery

Secondary outcomes (22)

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

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

    Measured: Within the first month after surgery

  2. The incidence of tumor

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

    Measured: 12 months after surgery

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

    Left ventricular wall thickness, interventricular septum thickness

    Measured: Baseline, 6 and 12 months after surgery

  4. Size of myocardial infarction as assessed by MRI

    Size of myocardial infarction

    Measured: Baseline, 6 and 12 months after surgery

  5. Ventricular wall motion as assessed by MRI

    Ventricular wall motion

    Measured: Baseline, 6 and 12 months after surgery

  6. Left ventricular ejection fraction as assessed by MRI

    Left ventricular ejection fraction

    Measured: Baseline, 6 and 12 months after surgery

  7. Cardiac Volumes as assessed by MRI

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

    Measured: Baseline, 6 and 12 months after surgery

  8. Cardiac output (CO) as assessed by MRI

    Cardiac output (CO)

    Measured: Baseline, 6 and 12 months after surgery

  9. End-diastolic myocardial mass as assessed by MRI

    End-diastolic myocardial mass

    Measured: Baseline, 6 and 12 months after surgery

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

    Left ventricular ejection fraction

    Measured: Baseline, 6 and 12 months after surgery

  11. Fractional shortening (FS) as assessed by Echocardiography

    Fractional shortening

    Measured: Baseline, 6 and 12 months after surgery

  12. Left ventricular dimensions as assessed by Echocardiography

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

    Measured: Baseline, 6 and 12 months after surgery

  13. Cardiac Volumes as assessed by Echocardiography

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

    Measured: Baseline, 6 and 12 months after surgery

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

    Mitral valve inflow spectrum (E/A)

    Measured: Baseline, 6 and 12 months after surgery

  15. Longitudinal strain as assessed by Echocardiography

    Longitudinal strain

    Measured: Baseline, 6 and 12 months after surgery

  16. Myocardial viability as assessed by SPECT

    Myocardial viability

    Measured: Baseline, 6 and 12 months after surgery

  17. Myocardial blood flow as assessed by SPECT

    Myocardial blood flow

    Measured: Baseline, 6 and 12 months after surgery

  18. NT-proBNP Levels

    The changes of NT-proBNP Levels

    Measured: Baseline, 6 and 12 months after surgery

  19. 6-minute walking distance

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

    Measured: Baseline, 6 and 12 months after surgery

  20. New York Heart Association (NYHA) functional classification

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

    Measured: Baseline, 6 and 12 months after surgery

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

    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.

    Measured: Baseline, 6 and 12 months after surgery

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

    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.

    Measured: Baseline, 6 and 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start5 Sep 2023
  3. Primary completion10 Nov 2026 (estimated)
  4. Study completion10 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06340048
Sponsor's protocol ID
XC Liu
Acronym
HEAL-AHF
Status last verified
Dec 2025
First submitted
15 Jan 2024
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HiCM-188 therapy in people with Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of major Serious Adverse Events (SAE) (time frame: Within the first month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06340048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in