NCT06340048Active, not recruitingPhase 1/2
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Ischemic Heart Failure
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
The purpose of this clinical study is to evaluate the feasibility, safety and efficacy of intramyocardial injection of human induce pluripotent stem cell-derived cardiomyocytes (HiCM-188) during coronary artery bypass grafting (CABG) surgery in patients with severe chronic ischemic heart failure.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 15 Jan 2024
- Start date
- 5 Sept 2023
- Primary completion date
- 10 Nov 2026
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT06340048
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 36
- From 5 Sept 2023 to the primary completion date, 10 Nov 2026
- 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
- Recipients of organ transplant.
- Patients undergoing other surgical operations (excluding resection of ventricular aneurysm and left atrial appendage excision/occlusion).
- Contraindication to CABG surgery
- Participation in another clinical trial within 3 months prior to screening
Other illness
- Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT)
- Diagnosed with malignancy within 5 years
- Autoimmune disease
- Severe ventricular arrhythmia
- Contraindication to cardiac MRI or PET/CT scan.
- Any other condition considered by the investigator to be inappropriate for inclusion in this clinical trial
Lab values
- Pregnancy, lactation, or a positive serum pregnancy test
Other
- Contraindication to immunosuppressants
Who the study is looking for
- Age ≥18 years
- Willingness and ability to give written informed consent
- Nuclide-myocardial metabolic perfusion imaging or Magnetic Resonance Imaging (MRI) revealed infarcted myocardium in the left anterior descending branch (LAD) coronary artery supply area
- LVEF\<50% as assessed by Echocardiography or LVEF≤40% as assessed by MRI
- Patients have indications for Coronary Artery Bypass Grafting
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| TEDA International Cardiovascular Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.