Treating Congestive HF With hiPSC-CMs Through Endocardial Injection (NCT04982081) | Clinical Trial Compass
UnknownPhase 1
Treating Congestive HF With hiPSC-CMs Through Endocardial Injection
China20 participantsStarted 2021-09-21
Plain-language summary
Heart failure is the primary cause of morbidity and mortality worldwide. Currently drug treatments for heart failure manage the symptoms, but not restore the loss cardiomyocytes due to the very limited regenerative capability in the adult heart. Novel reparative therapies that replace the cardiomyocytes loss are highly demanded to restore the cardiac function. The main purposes of this explanatory study is to investigate the safety and efficacy of the catheter-based endocardial delivery of human iPSC-derived cardiomyocytes in patients with congestive heart failure.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients aged 18-75 years (including 18 and 75).
✓. Signed the informed consent.
✓. Patients with congestive heart failure who have received regular treatment for heart failure.
✓. New York Heart Association (NYHA) Class III or IV despite optimal standard of care
✓. Left Ventricular Ejection Fraction (LVEF)\<40% as assessed by echocardiography ( measure in the 3 months of recruit is included, excluding the measured values within 1 month of myocardial infarction ）
✓. The thickness of left ventricular ≥8mm
✓. Female patient who is not pregnant or nursing during the clinical trial
Exclusion criteria
✕. PRA ≥ 20% or DSA positive.
✕. Patients received treatments such as pacemakers, ICD or CRT device.
✕. Patient with severe valvular disease or presence of a mechanical valve replacement, such as PCI implantation, or patients requiring simultaneous radiofrequency ablation of atrial fibrillation.