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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HiCM-188 therapy, CABG surgery.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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)
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.
Interventions
- Biological HiCM-188 therapy
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
Primary outcome measures
- 6-minute walk distance (6MWD) [Time frame: 12 months after surgery]
Secondary outcome measures (12)
- All-cause mortality and cardiovascular mortality [Time frame: 12 months after surgery]
- 6MWD [Time frame: 6 months after surgery]
- Change from baseline in the NYHA classification [Time frame: 12 months after surgery]
- Worsening heart failure (including events requiring hospitalization or emergency treatment due to worsening symptoms and signs of heart failure) [Time frame: 12 months after surgery]
- Change from baseline in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Time frame: 12 months after surgery]
- Change from baseline in the SF-36 questionnaire [Time frame: 12 months after surgery]
- Myocardial blood flow as assessed by SPECT [Time frame: 12 months after surgery]
- Myocardial viability as assessed by SPECT [Time frame: 12 months after surgery]
- Left ventricular ejection fraction as assessed by MRI [Time frame: 12 months after surgery]
- Cardiac Volumes as assessed by MRI [Time frame: 12 months after surgery]
- Scar size as assessed by MRI [Time frame: 12 months after surgery]
- Change from baseline in NT-proBNP level [Time frame: 12 months after surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
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;
- Females who are pregnant, lactating, or have a positive blood pregnancy test;
- Plans to conceive within one year;
- Having systemic diseases that are not effectively controlled;
- Other conditions deemed unsuitable for participation in this clinical trial as evaluated by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- TEDA International Cardiovascular Hospital — Tianjin
Identifiers
NCT: NCT07496372 · Liu XC