Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure (NCT05566600) | Clinical Trial Compass
UnknownEarly Phase 1
Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure
China32 participantsStarted 2022-10-09
Plain-language summary
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.
Who can participate
Age range35 Years – 75 Years
SexALL
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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 …
What they're measuring
1
Safety in terms of the incidence and severity of adverse events