Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure

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Status and phase: Enrolling; Early Phase 1

Conditions: Chronic Heart Failure; Ischemic Heart Failure

Treatments: Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05566600

JFYang

Details and patient eligibility

About

This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery.

After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.

Enrollment: 32 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Dose level 1

Experimental group

Description:

100 million iPSC-CMs administration

Treatment:

Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Dose level 2

Experimental group

Description:

200 million iPSC-CMs administration

Treatment:

Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Dose level 3

Experimental group

Description:

400 million iPSC-CMs administration

Treatment:

Biological: Human (allogeneic) iPS-cell-derived cardiomyocyte

Control

No Intervention group

Description:

Participants will received CABG surgery only