Health TrialsbyHealthPanel

IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure

ConditionsHeart FailureHeart Failure At NYHA Stage III or IV
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • low dose CABG+iPSC-CMs

    Biological/Vaccine

    CABG+0.5×10\^8 iPSC-CMs

  • High dose CABG/LVAD+iPSC-CMs

    Biological/Vaccine

    CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs

  • CABG/LVAD+Saline

    Other intervention

    CABG/LVAD+Saline

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Control groupSham comparator 1 intervention
Group B: Low Dose GroupExperimental treatment 1 intervention
Group C: High dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-minute walk test

Time frame
baseline, 1, 3, 6, 12 months post-operation
2

Major Adverse Cardiovascular Events

The composite endpoint events occurring during the prescribed postoperative follow-up period included cardiac death, non-fatal myocardial infarction, non-fatal stroke, and emergency target vessel revascularization (e.g., PCI or CABG), which was expressed as the percentage of subjects experiencing at least one of these events (%).

Time frame
From enrollment to the end of study at 12 months
3

Survival rate

Time frame
From enrollment to the end of study at 12 months

Secondary outcomes

1

Left ventricular ejection fraction

Improvement of left ventricular ejection fraction assessed by ECHO

Time frame
baseline, 1, 3, 6, 12 months post-operation
2

Cardiac magnetic resonance detection index

Myocardial infarction size and Myocardial fibrosis assessed by MRI

Time frame
baseline, 1, 3, 6, 12 months post-operation
3

BNP

BNP levels are measured by venous blood samples

Time frame
baseline, 1, 3, 6, 12 months post-operation
4

SF-36

life quality assessed by SF-36 (The Short-Form-36 Health Survey). The SF-36 scale is a tool used to assess health-related quality of life, including eight dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Each dimension has its unique scoring criteria, and the score range for each dimension is from 0 to 100 points. Higher scores indicate better health outcomes

Time frame
baseline, 1, 3, 6, 12 months post-operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HELP Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: