NCT06340048

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 heart-failure

Timeline
12mo left

Started Sep 2023

Longer than P75 for phase_1 heart-failure

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2023May 2027

Study Start

First participant enrolled

September 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2027

Last Updated

February 10, 2026

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

January 15, 2024

Last Update Submit

February 6, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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

    Within the first month after surgery

Secondary Outcomes (22)

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

    Within the first month after surgery

  • The incidence of tumor

    12 months after surgery

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

    Baseline, 6 and 12 months after surgery

  • Size of myocardial infarction as assessed by MRI

    Baseline, 6 and 12 months after surgery

  • Ventricular wall motion as assessed by MRI

    Baseline, 6 and 12 months after surgery

  • +17 more secondary outcomes

Study Arms (3)

HiCM-188 Low dose therapy

EXPERIMENTAL

Intramyocardial injection of HiCM-188 (50 million) during CABG surgery.

Drug: HiCM-188 therapy

HiCM-188 Medium dose therapy

EXPERIMENTAL

Intramyocardial injection of HiCM-188 (150 million) during CABG surgery.

Drug: HiCM-188 therapy

HiCM-188 High dose therapy

EXPERIMENTAL

Intramyocardial injection of HiCM-188 (450 million) during CABG surgery.

Drug: HiCM-188 therapy

Interventions

HiCM-188 therapyDRUG

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

HiCM-188 High dose therapyHiCM-188 Low dose therapyHiCM-188 Medium dose therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2024

First Posted

April 1, 2024

Study Start

September 5, 2023

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

May 10, 2027

Last Updated

February 10, 2026

Record last verified: 2025-12

Locations

CN(1)