Using stem cells to treat heart failure during bypass surgery

Epicardial Injection of Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure

This study is testing if injecting special stem cells into the heart during bypass surgery can help people with chronic heart failure feel better and improve their heart function.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Help Therapeutics (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05223894 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of delivering allogenic human pluripotent stem cell-derived cardiomyocytes directly into the heart muscle during coronary artery bypass grafting for patients with chronic heart failure. Participants will be monitored for one year post-treatment to assess improvements in heart function and overall health. The approach seeks to repair damaged heart tissue, which is crucial since the heart has limited regenerative capabilities. By utilizing stem cell therapy, the study hopes to provide a new avenue for treating heart failure beyond traditional medication.

Who should consider this trial

Good fit: Ideal candidates are adults aged 35-75 with chronic left ventricular dysfunction and severe heart failure symptoms despite medication.

Not a fit: Patients with advanced heart conditions such as valvular heart disease or those who have received certain cardiac interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart function and quality of life for patients with chronic heart failure.

How similar studies have performed: While cellular replacement therapy is a novel approach, similar studies have shown promise in early phases, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Aged 35-75 (including 35 and 75).
2. Have signed the Informed Consent Form (ICF).
3. Patients have chronic left ventricular dysfunction.
4. Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
5. Patients have indications for Coronary Artery Bypass Grafting.
6. 20% ≤ LVEF ≤ 40% as determined by echocardiogram (data collected up to 3 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid).
7. Weakening or absence of segmental regional wall motion as determined by standard imaging.

Exclusion Criteria:

1. PRA ≥ 20% or DSA-positive.
2. Patient received ICD transplantation, CRT or similar treatment.
3. Patients with valvular heart disease or received heart valvular disease
4. Patients received treatment of percutaneous transluminal coronary intervention (PCI)
5. Patients with atrial fibrillation
6. Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
7. Baseline glomerular filtration rate \<30ml/min/1.73m2.
8. Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
9. Hematological abnormality: A hematocrit \<25% as determined by HCT, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation.
10. Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
11. Coagulopathy (INR\>1.3) not due to a reversible cause.
12. Contra-indication to performance of a MRI scan.
13. Recipients of organ transplant.
14. Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
15. Non-cardiac condition that limits lifespan \<1 year.
16. On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNF-α antagonist.
17. Patients allergy to or cannot use immunosuppressant.
18. Serum positive for HIV, HBV, HCV, TP.
19. Currently enrolled other investigational therapeutic or device study.
20. Patients who are pregnant or breast feeding.
21. Other conditions that researchers consider not suitable to participate in this study.

Where this trial is running

Shanghai, Shanghai

• Shanghai east Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Zhongmin Liu, MD,phD — Shanghai East Hospital
• Study coordinator: Gang Yang, MD,PhD

Conditions Heart Failure