Using stem cell-derived heart cells to treat heart failure

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

This study is testing whether injecting heart cells made from stem cells into the heart can help people with chronic heart failure feel better and improve their heart function after surgery.

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 (Nanjing, Jiangsu)
• Trial ID: NCT03763136 on ClinicalTrials.gov

What this trial studies

This study investigates the safety, feasibility, and efficacy of injecting 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 at 1, 3, 6, and 12 months post-treatment to evaluate the impact on cardiac function. The goal is to restore damaged heart tissue and improve overall heart performance, addressing a critical limitation of current heart failure therapies.

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 optimal medical therapy.

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

Why it matters

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

How similar studies have performed: While cellular replacement therapies are still emerging, there have been promising results in similar studies exploring stem cell applications in heart failure treatment.

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 ≤ 45% as determined by echocardiogram (data collected up to 6 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 TNFα 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

Nanjing, Jiangsu

• HelpThera — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Dongjin Wang, MD — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Study coordinator: Jiaxian Wang, MD, PhD

Conditions Heart Failure