Phase
Condition
Hyponatremia
Chest Pain
Heart Failure
Treatment
hPSC-CM Therapy
Clinical Study ID
Ages 35-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
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.
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.
Study Design
Study Description
Connect with a study center
HelpThera
Nanjing, Jiangsu 210000
ChinaSite Not Available
HelpThera
Nanjing 1799962, Jiangsu 1806260 210000
ChinaSite Not Available

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