HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
Advanced Heart Failure · Ischemic Heart Failure
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 12 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
This is a Phase I/IIa, open-label, dose-escalation study of HiCM-188 in adult participants with advanced heart failure. HiCM-188 is an investigational cell therapy product consisting of allogeneic human iPSC-derived cardiomyocytes intended for intramyocardial administration.
Eligible participants will receive HiCM-188 during coronary artery bypass grafting (CABG) surgery. The study uses a 3+3 dose-escalation design to evaluate two dose levels of HiCM-188: 0.5 × 10\^8 cells and 1.5 × 10\^8 cells. The primary objective is to evaluate the safety and tolerability of intramyocardial injection of HiCM-188. Secondary objectives include evaluation of preliminary efficacy based on cardiac function, myocardial perfusion, exercise capacity, NYHA functional classification, quality of life, and major adverse cardiac events.
Participants will be monitored during the in-hospital period after CABG surgery and HiCM-188 administration, and then followed for up to 12 months after treatment.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Viral myocarditis
- Amyloidosis
- Pericardial disorders or pericarditis
- Left ventricular aneurysm or thrombus, except a small laminar thrombus at the site of previous myocardial infarction (MI) in a different area
- Primary significant organic valvular heart disease, with specified dimensions
- Untreated congenital heart disease
- Complete atrioventricular (AV) conduction block
- History of left ventricular assist device surgery
- Other criteria apply. Please contact the investigator for more information.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
HiCM-188 Low Dose
Participants in this arm will receive a single low dose of HiCM-188, 0.5 × 10\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
Drug: HiCM-188 Cells
HiCM-188 High Dose
Participants in this arm will receive a single high dose of HiCM-188, 1.5 × 10\^8 cells, administered by intramyocardial injection during coronary artery bypass grafting (CABG) surgery.
Drug: HiCM-188 Cells
HiCM-188 Cells DRUG
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Incidence of Serious Adverse Events
Time frame: Up to 12 months post-transplant
Incidence of serious adverse events (SAEs) at 12 months post-transplant
Secondary measures
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
Time frame: Baseline, 6 months, and 12 months
Change from baseline in left ventricular ejection fraction (LVEF, %) assessed by cardiac magnetic resonance imaging (MRI). Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI
Time frame: Baseline, 6 months, and 12 months
Change from baseline in left ventricular end-diastolic volume (LVEDV, mL) assessed by cardiac MRI. Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI
Time frame: Baseline, 6 months, and 12 months
Change from baseline in left ventricular end-systolic volume (LVESV, mL) assessed by cardiac MRI. Echocardiogram may be used as an alternative if cardiac MRI is not medically appropriate or per institutional practice.
Change From Baseline in Infarct Size by Cardiac MRI
Time frame: Baseline, 6 months, and 12 months
Change from baseline in myocardial infarct size assessed by cardiac MRI.
Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT
Time frame: Baseline, 6 months, and 12 months
Change from baseline in myocardial tissue perfusion assessed by positron emission tomography/computed tomography (PET/CT) or single-photon emission computed tomography (SPECT).
Change From Baseline in 6-Minute Walk Distance
Time frame: Baseline, 6 months, and 12 months
Change from baseline in exercise capacity as assessed by the 6-minute walk distance (6MWD). The 6-Minute Walk Distance is measured as the distance walked in 6 minutes, with longer distances reflecting better functional exercise capacity.
Change From Baseline in New York Heart Association Functional Classification
Time frame: Baseline, 6 months, and 12 months
Change from baseline in New York Heart Association (NYHA) functional classification. The New York Heart Association Functional Classification ranges from Class I to Class IV, with higher classes reflecting more severe limitation of physical activity and worse heart failure symptoms.
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
Time frame: Baseline, 6 months, and 12 months
Change from baseline in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The Minnesota Living With Heart Failure Questionnaire score ranges from 0 to 105, with higher scores reflecting worse heart failure-related quality of life.
Incidence of Major Adverse Cardiac Events
Time frame: Up to 12 months post-transplant
Incidence of major adverse cardiac events (MACE) during the study follow-up period.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
The Texas Heart Institute at Baylor College of MedicineHouston, Texas, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- HELP Therapeutics, Inc.
- Study start
- 2027-02 Estimated
- Primary completion
- 2028-02 Estimated
- Study completion
- 2029-02 Estimated
- First posted
- Jun 12, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
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
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026