NCT06866600Not yet recruitingPhase 1/2
IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- Mar 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT06866600
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From Mar 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute myocardial infarction or history of percutaneous coronary intervention (PCI) within 1 month prior to screening.
- Acute cerebrovascular event within 1 month prior to screening.
- Planned concurrent major surgery (excluding left ventricular aneurysm resection or left atrial appendage closure/resection).
- Contraindications for CABG surgery.
- Contraindications to immunosuppressive therapy or inability to comply with the protocol-specified immunosuppressive regimen.
- Participation in another clinical trial within 3 months prior to screening.
Other illness
- History of pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
- Severe valvular heart disease.
- History of malignancy within 5 years prior to screening.
- Autoimmune disease or chronic use of immunosuppressive agents.
- History of organ transplantation.
- Malignant ventricular arrhythmia.
- 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.
- Any other condition deemed by the investigator to render the patient unsuitable for trial participation.
Lab values
- Hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, tacrolimus, macrolides, prednisone acetate/methylprednisolone, other corticosteroids, or basiliximab.
Other
- Non-ischemic cardiomyopathy or acute viral myocarditis.
- Pregnancy, lactation, or positive pregnancy test in female patients.
Who the study is looking for
- 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.
Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HelpThera Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.