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

NCT06866600 | Not Yet Recruiting Phase 1

• 1 other identifier: SYF, WLS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Heart Failure At NYHA Stage III or IV

Keywords

LVAD; CABG; iPSC-CMs

Outcome Measures

Primary Outcomes (3)

• 6-minute walk test

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

• 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 (%).

  From enrollment to the end of study at 12 months

• Survival rate

  From enrollment to the end of study at 12 months

Secondary Outcomes (6)

• Left ventricular ejection fraction

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

• Cardiac magnetic resonance detection index

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

• BNP

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

• SF-36

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

• KCCQ

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

Study Arms (3)

Control group

SHAM COMPARATOR

CABG combined with saline or LVAD combined with saline

Other: CABG/LVAD+Saline

Low Dose Group

EXPERIMENTAL

CABG combined with 0.5×10\^8 iPSC-CMs

Biological: low dose CABG+iPSC-CMs

High dose group

EXPERIMENTAL

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

Biological: High dose CABG/LVAD+iPSC-CMs

Interventions

low dose CABG+iPSC-CMs BIOLOGICAL

CABG+0.5×10\^8 iPSC-CMs

Low Dose Group

High dose CABG/LVAD+iPSC-CMs BIOLOGICAL

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

High dose group

CABG/LVAD+Saline OTHER

CABG/LVAD+Saline

Control group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• Definitive indication for LVAD implantation due to end-stage heart failure.
• Anticipated significant improvement in hemodynamic stability post-LVAD implantation, with potential for further cardiac functional improvement via myocardial cell injection.
• Absence of significant contraindications for LVAD surgery.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Help Therapeutics: lead

Study Sites (1)

HelpThera

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Yongfeng Shao, MD, PhD

  Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)

  PRINCIPAL INVESTIGATOR

• Liansheng Wang, MD, PhD

  Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaxian Wang, MD, PhD

CONTACT

+86-18565616060; wangjx@helpsci.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CN (1)