NCT03763136CompletedPhase 1/2
Treating Heart Failure With hPSC-CMs
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 9 Nov 2018
- Start date
- 8 Oct 2021
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT03763136
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- From 8 Oct 2021 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 previously suffered sustained ventricular tachycardia or sudden cardiac death.
- Recipients of organ transplant.
- On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFα antagonist.
Other illness
- Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
- 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.
- Patients allergy to or cannot use immunosuppressant.
- Other conditions that researchers consider not suitable to participate in this study.
Lab values
- 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.
- Coagulopathy (INR\>1.3) not due to a reversible cause.
- Serum positive for HIV, HBV, HCV, TP.
Other
- PRA ≥ 20% or DSA-positive.
- Patients with atrial fibrillation
- Baseline glomerular filtration rate \<30ml/min/1.73m2.
- Contra-indication to performance of a MRI scan.
- Currently enrolled other investigational therapeutic or device study.
- Patients who are pregnant or breast feeding.
Who the study is looking for
- Aged 35-75 (including 35 and 75).
- Have signed the Informed Consent Form (ICF).
- Patients have chronic left ventricular dysfunction.
- Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
- Patients have indications for Coronary Artery Bypass Grafting.
- 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).
- Weakening or absence of segmental regional wall motion as determined by standard imaging.
Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HelpThera Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.