IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
NCT ID: NCT06866600
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2025-03-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
CABG combined with saline or LVAD combined with saline
CABG/LVAD+Saline
CABG/LVAD+Saline
Low Dose Group
CABG combined with 0.5×10\^8 iPSC-CMs
low dose CABG+iPSC-CMs
CABG+0.5×10\^8 iPSC-CMs
High dose group
CABG combined with 1.5×10\^8 iPSC-CMs or LVAD combined with 1.5×10\^8 iPSC-CMs
High dose CABG/LVAD+iPSC-CMs
CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
Interventions
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low dose CABG+iPSC-CMs
CABG+0.5×10\^8 iPSC-CMs
High dose CABG/LVAD+iPSC-CMs
CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs
CABG/LVAD+Saline
CABG/LVAD+Saline
Eligibility Criteria
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Inclusion Criteria
* 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.
* Echocardiography demonstrating regional hypokinesia or akinesia of the ventricular wall.
* Cardiac magnetic resonance imaging (MRI) confirming left ventricular ejection fraction (LVEF) ≤35%.
* Myocardial perfusion-metabolism imaging with radionuclide indicating infarcted myocardium in the left anterior descending (LAD) artery territory.
* Meets criteria for coronary artery bypass grafting (CABG) under cardiopulmonary bypass during screening and requires CABG surgery.
* For patients enrolled in the LVAD implantation group, the following additional criteria must be met:
1. Definitive indication for LVAD implantation due to end-stage heart failure.
2. Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
3. Absence of significant contraindications for LVAD surgery.
Exclusion Criteria
* 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.
* Acute cerebrovascular event within 1 month prior to screening.
* History of malignancy within 5 years prior to screening.
* Autoimmune disease or chronic use of immunosuppressive agents.
* History of organ transplantation.
* Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
* Malignant ventricular arrhythmia.
* Contraindications for CABG surgery.
* Positive serology for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody.
* Inability to undergo cardiac MRI or PET/CT imaging.
* Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
* Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.
* Participation in another clinical trial within 3 months prior to screening.
* Pregnancy, lactation, or positive pregnancy test in female patients.
* Any other condition deemed by the investigator to render the patient unsuitable for trial participation.
35 Years
75 Years
ALL
No
Sponsors
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Help Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Yongfeng Shao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
Liansheng Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)
Locations
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HelpThera
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYF, WLS
Identifier Type: -
Identifier Source: org_study_id
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