NCT07496372

Brief Summary

The purpose of this clinical study is to evaluate the efficacy and safety of intramyocardial injection of human induced pluripotent stem cell-derived cardiomyocyte injection (HiCM-188) in patients with advanced heart failure (NYHA Class III-IV)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
14mo left

Started Apr 2026

Shorter than P25 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
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 Progress10%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

March 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

May 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 16, 2026

Last Update Submit

May 7, 2026

Conditions

Heart Failure

Keywords

Advanced heart failureHiCM188HiCM-188REVIVE-HEARTcardiomyocyte

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk distance (6MWD)

    12 months after surgery

Secondary Outcomes (14)

  • All-cause mortality and cardiovascular mortality

    12 months after surgery

  • 6MWD

    6 months after surgery

  • Change from baseline in the NYHA classification

    12 months after surgery

  • Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure)

    12 months after surgery

  • Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    12 months after surgery

  • +9 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Coronary artery bypass grafting surgery

Procedure: CABG surgery

Experimental group

EXPERIMENTAL

Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery

Biological: HiCM-188 therapyProcedure: CABG surgery

Interventions

HiCM-188 therapyBIOLOGICAL

Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery

Experimental group
CABG surgeryPROCEDURE

Conventional coronary artery bypass grafting (CABG) surgery

Control groupExperimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 75 years, regardless of gender;
  • Patients with ischemic heart failure with NYHA functional class III or IV after receiving the maximum tolerated dose of guideline-directed medical therapy (GDMT);
  • LVEF ≤ 35% as measured by cardiac MRI;
  • Coronary angiography meeting the indications for coronary artery bypass grafting (CABG) surgery;
  • Voluntary participation and signing of the informed consent form.

You may not qualify if:

  • Patients considered for this trial must not meet any of the following criteria:
  • Acute viral myocarditis;
  • Acute phase of myocardial infarction (≤ 3 months);
  • Cardiac amyloidosis;
  • Pericarditis;
  • Expected to undergo heart transplantation;
  • Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
  • Suffering from autoimmune diseases;
  • Estimated glomerular filtration rate (eGFR) \< 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 100 U/L;
  • Presence of any untreated precancerous lesions or those requiring active monitoring;
  • Occurrence of malignant tumors within 5 years prior to screening;
  • Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
  • Having contraindications to the use of immunosuppressants;
  • Having contraindications to MRI;
  • Having contraindications to CABG surgery;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 27, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

May 12, 2026

Record last verified: 2026-03

Locations

CN(1)