Actively Recruiting
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)
Led by HELP Therapeutics Co., Ltd. · Updated on 2026-05-12
80
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, regardless of gender
- Diagnosed with ischemic heart failure classified as NYHA functional class III or IV after maximum tolerated guideline-directed medical therapy
- Left ventricular ejection fraction (LVEF) of 35% or less measured by cardiac MRI
- Coronary angiography indicating the need for coronary artery bypass grafting (CABG) surgery
- Voluntarily agree to participate and sign informed consent form
You will not qualify if you...
- Acute viral myocarditis
- Acute myocardial infarction within the past 3 months
- Cardiac amyloidosis
- Pericarditis
- Expected to undergo heart transplantation
- Diseases limiting motor ability preventing completion of 6-minute walk test
- Autoimmune diseases
- Estimated glomerular filtration rate (eGFR) less than 35 ml/min/1.73m² or AST and ALT levels over 100 U/L
- Untreated precancerous lesions or those requiring active monitoring
- Malignant tumors diagnosed within 5 years prior to screening
- Planned concurrent cardiac surgeries other than ventricular aneurysm resection or left atrial appendage excision/ligation
- Contraindications to immunosuppressants
- Contraindications to MRI
- Contraindications to CABG surgery
- Females who are pregnant, breastfeeding, or have a positive pregnancy test
- Plans to conceive within one year
- Uncontrolled systemic diseases
- Other conditions assessed by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, China, 300457
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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