Using stem cells to treat worsening ischemic heart failure during heart surgery
Epicardial Injection of Allogeneic 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 surgery can help people with worsening heart failure feel better and improve their heart function.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | Help Therapeutics Industry-sponsored |
| Locations | 2 sites (Changsha, Hunan and 1 other locations) |
| Trial ID | NCT05566600 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of allogeneic induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) in patients with worsening ischemic heart failure who are undergoing coronary artery bypass graft (CABG) surgery. Eligible patients will receive iPSC-CMs administered directly into the heart muscle during the surgical procedure. The study aims to enroll 32 patients and will assess improvements in heart function and overall health following treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35-75 with chronic left ventricular dysfunction and NYHA Class III-IV heart failure who are scheduled for CABG surgery.
Not a fit: Patients with certain heart conditions such as valvular heart disease or those who have received specific cardiac interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve heart function and quality of life for patients with severe ischemic heart failure.
How similar studies have performed: While the use of iPSC-derived therapies is a novel approach, similar studies have shown promise in regenerative medicine, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 35-75 (including 35 and 75). * Signed the Informed Consent Form (ICF). * Have chronic left ventricular dysfunction. * Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure. * Have indications for Coronary Artery Bypass Grafting. * LVEF \< 40% 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). * Weakening or absence of segmental regional wall motion as determined by standard imaging Exclusion Criteria: * PRA ≥ 20% or DSA-positive * Patient received ICD transplantation, CRT or similar treatment. * Patients with valvular heart disease or received heart valvular disease * Patients received treatment of percutaneous transluminal coronary intervention (PCI) * Patients with atrial fibrillation * Patients previously suffered sustained ventricular tachycardia or sudden cardiac death. * Baseline glomerular filtration rate \<30ml/min/1.73m2. * Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN. * Hematological abnormality: A hematocrit \<25% as determined by HCT, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation. * Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy. * Coagulopathy (INR\>1.3) not due to a reversible cause. * Contra-indication to performance of a MRI scan. * Recipients of organ transplant. * Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years). * Non-cardiac condition that limits lifespan \<1 year. * On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFα antagonist. * Patients allergy to or cannot use immunosuppressant. * Serum positive for HIV, HBV, HCV, TP. * Currently enrolled other investigational therapeutic or device study. * Patients who are pregnant or breast feeding. * Other conditions that researchers consider not suitable to participate in this study.
Where this trial is running
Changsha, Hunan and 1 other locations
- The second xiangya hospital of central south university — Changsha, Hunan, China (Recruiting)
- HelpThera — Nanjing, Jiangsu, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Jiaxian Wang
- Email: wangjx@helpsci.com.cn
- Phone: +86-18565616060
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.