Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
NCT ID: NCT06340048
Last Updated: 2024-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2023-09-05
2025-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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HiCM-188 Low dose therapy
Intramyocardial injection of HiCM-188 (50 million) during CABG surgery.
HiCM-188 therapy
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery
HiCM-188 Medium dose therapy
Intramyocardial injection of HiCM-188 (150 million) during CABG surgery. Interventions
HiCM-188 therapy
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery
HiCM-188 High dose therapy
Intramyocardial injection of HiCM-188 (450 million) during CABG surgery. Interventions
HiCM-188 therapy
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery
Interventions
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HiCM-188 therapy
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes (HiCM-188) during coronary artery bypass grafting surgery
Eligibility Criteria
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Inclusion Criteria
2. Willingness and ability to give written informed consent
3. Patients with severe chronic ischemic heart failure
4. New York Heart Association (NYHA) Class III or IV under optimal medical therapy
5. Weakening or absence of segmental regional wall motion as determined by standard imaging.
6. LVEF≤40% as assessed by MRI
7. Nuclide-myocardial metabolic perfusion imaging revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
8. Patients have indications for Coronary Artery Bypass Grafting
Exclusion Criteria
2. Patients with severe valvular heart disease
3. Patients had acute myocardial infarction or underwent percutaneous coronary intervention (PCI) surgery within 1 month
4. Patients with non-ischemic heart failure, acute viral myocarditis.
5. Patients had acute cerebrovascular events within 1 month before screening.
6. Diagnosed with malignancy within 5 years
7. Autoimmune disease or long-term therapy with immunosuppressant
8. Recipients of organ transplant.
9. Patients undergoing other surgical operations (excluding resection of ventricular aneurysm).
10. Severe ventricular arrhythmia
11. Contraindication to CABG surgery
12. Serum-positive for HIV, hepatitis BsAg, HCV and TP.
13. Contraindication to performance of MRI or PET/CT scan.
14. Contraindication to use immunosuppressant
15. Be allergic to immunosuppressant
16. Patients who had participated in other clinical trials within 3 months
17. Women are pregnant, breastfeeding or blood pregnancy test positive
18. Patients with other conditions are not eligible to participate in this clinical trial
35 Years
75 Years
ALL
No
Sponsors
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TEDA International Cardiovascular Hospital
OTHER
Help Therapeutics
INDUSTRY
Responsible Party
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Locations
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TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaocheng Liu
Role: primary
Other Identifiers
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XC Liu
Identifier Type: -
Identifier Source: org_study_id
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