NCT07646210Not yet recruitingPhase 1/2
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery. Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- May 2028
- Lead sponsor
- HELP Therapeutics Co., Ltd.
- Diseases
- Heart failure
- NCT number
- NCT07646210
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From Sept 2026 to the primary completion date, May 2028
- 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
- Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
Other illness
- Pericardial disorders or pericarditis
- Primary significant organic valvular heart disease, with specified dimensions
- Untreated congenital heart disease
- History of left ventricular assist device surgery
Other
- Viral myocarditis
- Amyloidosis
- Complete atrioventricular (AV) conduction block
- Other criteria apply. Please contact the investigator for more information.
Who the study is looking for
- Able to sign informed consent and comply with the study protocol
- 18 to 75 years old at the time of signing informed consent
- Advanced heart failure patients with New York Heart Association (NYHA) class III to IVa despite receiving guideline-directed medical therapy (GDMT)
- Patients with an indication for coronary artery bypass grafting (CABG) per 2011 ACCF/AHA Guideline meeting a Class of Recommendation (COR) of Class I or Class IIa
- Minimum left ventricular wall thickness of ≥ 8 mm in the areas of injection, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- Left ventricular ejection fraction (LVEF) of 20% to 45%, as confirmed on the screening echocardiogram (ECHO) or cardiac MRI
- Other criteria apply. Please contact the investigator for more information.
Age in the registry: 18 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 |
|---|---|---|---|
| The Texas Heart Institute at Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.