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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600124230

Enrollment

Unknown

Registered

2026-05-09

Start date

2026-05-14

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Heart Failure

Interventions

Trial Group:Conventional coronary artery bypass grafting (CABG) combined with intramyocardial injection of human iPSC-derived cardiomyocyte injection fluid (HiCM-188), dose of 1.5×10^6 cells per injec

Control Group:Conventional coronary artery bypass grafting (CABG)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 75 years old, gender not restricted; 2. Patients with NYHA cardiac function classification of III or IV grade ischemic heart failure after the maximum tolerated dose of guideline-directed medical therapy (GDMT); 3. Cardiac magnetic resonance LVEF <= 35%; 4. Coronary angiography meets the surgical indications for CABG; 5. Voluntary participation and signing of informed consent form.

Exclusion criteria

Exclusion criteria: 1. Acute viral myocarditis; 2. Acute phase of myocardial infarction ( 100 U/L; 9. Having any precancerous lesions that require no treatment or need active monitoring; 10. Those who have suffered from malignant tumors within the previous 5 years. 11. Those who are scheduled to undergo other cardiac surgeries at the same time (excluding ventricular aneurysm resection and left atrial resection/sealing). 12. Those with contraindications to taking immunosuppressants. 13. Those with MRI contraindications. 14. Those with contraindications for CABG surgery. 15. Women who are pregnant, breastfeeding, or have positive blood pregnancy tests. 16. Those with a fertility plan within one year. 17. Those with uncontrolled systemic diseases. 18. Other individuals assessed by the researchers as not suitable to participate in this clinical trial.

Design outcomes

Primary

Measure	Time frame
6-Minute Walk Distance (6MWD);	—

Secondary

Measure	Time frame
All-Cause Mortality and Cardiovascular Mortality at 12 Months Postoperatively;6-Minute Walk Distance (6MWD) at 6 Months Postoperatively;Change in NYHA Classification Relative to Baseline at 12 Months Postoperatively;Heart Failure Worsening at 12 Months Postoperatively;Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score Relative to Baseline at 12 Months Postoperatively;Change in Short Form-36 Health Survey (SF-36) Score Relative to Baseline at 12 Months Postoperatively;Change in Myocardial Perfusion Parameters Relative to Baseline at 12 Months Postoperatively;Change in Cardiac Structural Parameters (LVEF, LVESVI, LVEDVI, SV, Scar Size) Relative to Baseline at 12 Months Postoperatively;Change in NT-proBNP Level Relative to Baseline at 12 Months Postoperatively;Abnormal Increase in Tumor Markers Relative to Baseline at 12 Months Postoperatively;	—

Measure

Time frame

All-Cause Mortality and Cardiovascular Mortality at 12 Months Postoperatively;6-Minute Walk Distance (6MWD) at 6 Months Postoperatively;Change in NYHA Classification Relative to Baseline at 12 Months Postoperatively;Heart Failure Worsening at 12 Months Postoperatively;Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score Relative to Baseline at 12 Months Postoperatively;Change in Short Form-36 Health Survey (SF-36) Score Relative to Baseline at 12 Months Postoperatively;Change in Myocardial Perfusion Parameters Relative to Baseline at 12 Months Postoperatively;Change in Cardiac Structural Parameters (LVEF, LVESVI, LVEDVI, SV, Scar Size) Relative to Baseline at 12 Months Postoperatively;Change in NT-proBNP Level Relative to Baseline at 12 Months Postoperatively;Abnormal Increase in Tumor Markers Relative to Baseline at 12 Months Postoperatively;

—

Countries

China

Contacts

Public ContactLiu Xiaocheng

Teda International Cardiovascular Hospital, Chinese Academy of Medical Sciences Peking Union Medical College

liuxc@tedaich.com+86 22 65208030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026