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)
Recruiting
Phase 3Interventional Study
Heart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
HELP Therapeutics Co., Ltd. · Industry
Who this trial is looking for
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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 Locations
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Status
Eligibility Criteria
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 m…
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.
Contacts
No contact information available.
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