A Pivotal Clinical Trial of Human Induced Pluripotent Stem Cell-derived Cardiomyocytes Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV) (REVIVE-HEART)

A Pivotal Multicenter, Randomized, Controlled Trial to Evaluate the Efficacy and Safety of Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) for the Treatment of Advanced Heart Failure(NYHA III-IV)

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)

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: CABG surgery; Biological: HiCM-188 therapy

Detailed Description

REVIVE-HEART is a multicenter, randomized, controlled, confirmatory clinical trial evaluating patients with advanced heart failure (NYHA III-IV). Participants were assigned to receive either conventional coronary artery bypass grafting (CABG) alone or CABG combined with HiCM-188 (150 million cells). The cells were administered via myocardial injections around the infarcted area, followed by postoperative immunosuppressive therapy. Efficacy and safety were assessed 12 months post-treatment.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300457
      • Recruiting
      • Teda International Cardiovascular Hospital
      • Contact: Xiaocheng Liu; Phone Number: +86-022-65208030; Email: liuxc@tedaich.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients considered for this trial must not meet any of the following criteria:

1. Acute viral myocarditis;
2. Acute phase of myocardial infarction (≤ 3 months);
3. Cardiac amyloidosis;
4. Pericarditis;
5. Expected to undergo heart transplantation;
6. Suffering from a disease that restricts the motor system, making them unable to complete the 6-minute walk test;
7. Suffering from autoimmune diseases;
8. Estimated glomerular filtration rate (eGFR) < 35 ml/min/1.73m², or aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 100 U/L;
9. Presence of any untreated precancerous lesions or those requiring active monitoring;
10. Occurrence of malignant tumors within 5 years prior to screening;
11. Expected to undergo other concurrent cardiac surgeries (excluding ventricular aneurysm resection and left atrial appendage excision/ligation);
12. Having contraindications to the use of immunosuppressants;
13. Having contraindications to MRI;
14. Having contraindications to CABG surgery;
15. Females who are pregnant, lactating, or have a positive blood pregnancy test;
16. Plans to conceive within one year;
17. Having systemic diseases that are not effectively controlled;
18. Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Coronary artery bypass grafting surgery	Procedure: CABG surgery; Conventional coronary artery bypass grafting (CABG) surgery
Experimental: Experimental group; Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery	Procedure: CABG surgery; Conventional coronary artery bypass grafting (CABG) surgery; Biological: HiCM-188 therapy; Intramyocardial Injection of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) during coronary artery bypass grafting surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-minute walk distance (6MWD)	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 lower scores reflect better health status.	12 months after surgery
Change from baseline in the SF-36 questionnaire	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.	12 months after surgery
Myocardial blood flow as assessed by SPECT		12 months after surgery
Myocardial viability as assessed by SPECT		12 months after surgery
Left ventricular ejection fraction as assessed by MRI	Left ventricular ejection fraction	12 months after surgery
Cardiac Volumes as assessed by MRI	Left ventricular end-diastolic volume index (LVEDVi), Left ventricular end-systolic volume index (LVESVi) and Stroke Volume (SV)	12 months after surgery
Scar size as assessed by MRI		12 months after surgery
Change from baseline in NT-proBNP level		12 months after surgery
Tumor markers abnormally elevated compared to baseline		12 months after surgery
Other AEs		12 months after surgery

Collaborators and Investigators

• Sponsor: HELP Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Advanced heart failure; cardiomyocyte; HiCM188; HiCM-188; REVIVE-HEART
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: Liu XC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No