Injecting stem cells to treat severe heart failure during bypass surgery
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure
This study is testing if injecting special heart cells during bypass surgery can help people with severe heart failure feel better and improve their heart function.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | Help Therapeutics Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT06340048 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the feasibility, safety, and efficacy of injecting human induced pluripotent stem cell-derived cardiomyocytes (HiCM-188) into the heart muscle during coronary artery bypass grafting (CABG) surgery for patients suffering from severe chronic ischemic heart failure. It is a single-center, open-label study that includes a dose-escalation phase followed by a dose-extension phase, involving up to 36 patients. Participants will receive the HiCM-188 injection and will be monitored for safety and effectiveness, requiring immunosuppressant therapy post-procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35-75 with severe chronic ischemic heart failure, classified as NYHA Class III or IV, and who are eligible for CABG surgery.
Not a fit: Patients with non-ischemic heart failure or those who have had recent cardiac interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart function and quality of life for patients with severe chronic ischemic heart failure.
How similar studies have performed: While the use of stem cells in cardiac therapies is being explored, this specific approach of intramyocardial injection during CABG is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 35-75 years of age (including 35 and 75 years) 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: 1. Patient with pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) treatment. 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
Where this trial is running
Tianjin, Tianjin
- TEDA International Cardiovascular Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Xiaocheng Liu
- Email: liuxc@tedaich.com
- Phone: +86-022-65208030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.