IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age35-75
SponsorHELP Therapeutics Co., Ltd.
About this trial
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.
Eligibility criteria
Qualifiers
Male or female aged 35-75 years (inclusive) at the time of signing the informed consent form.
Capable of understanding the informed consent form, voluntarily agreeing to participate in the trial, and signing the informed consent form.
Diagnosed with end-stage heart failure.
Receiving optimized medical therapy for heart failure, with New York Heart Association (NYHA) functional class III-IV.
Disqualifiers
History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
Severe valvular heart disease.
Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
Non-ischemic cardiomyopathy or acute viral myocarditis.
Trial design
Treatments tested in this trial
- low dose CABG+iPSC-CMs
- High dose CABG/LVAD+iPSC-CMs
- CABG/LVAD+Saline
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov