HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery

NCT07646210 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HICM188H1101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Heart Failure; Ischemic Heart Failure

Keywords

HiCM-188; iPSC-derived cardiomyocytes; Allogeneic cell therapy; Advanced heart failure; Ischemic heart failure; Intramyocardial injection; Coronary artery bypass grafting; CABG; Dose escalation; NYHA Class III-IVa

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events

  Incidence of serious adverse events (SAEs) at 12 months post-transplant

  Up to 12 months post-transplant

Secondary Outcomes (9)

• Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI

  Baseline, 6 months, and 12 months

• Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI

  Baseline, 6 months, and 12 months

• Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI

  Baseline, 6 months, and 12 months

• Change From Baseline in Infarct Size by Cardiac MRI

  Baseline, 6 months, and 12 months

• Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT

  Baseline, 6 months, and 12 months

Study Arms (2)

HiCM-188 Low Dose

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

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.

HiCM-188 High Dose; HiCM-188 Low Dose

Eligibility Criteria

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

You may qualify if:

• Able to sign informed consent and comply with the study protocol
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HELP Therapeutics Co., Ltd.: lead

Study Sites (1)

The Texas Heart Institute at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Central Study Contacts

Alex Zhang

CONTACT

+1 650 504 5586; Alex.zhang@helptx.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label 3+3 dose-escalation study. Eligible participants with advanced heart failure will be enrolled sequentially and will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. Two dose levels are planned: 0.5 × 10\^8 cells and 1.5 × 10\^8 cells. Dose escalation will proceed based on dose-limiting toxicity (DLT) criteria.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)