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Advanced Heart FailurePhase 1/2NCT07646210

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

A Phase 1/2 study testing HiCM-188 Cells in people with Advanced Heart Failure and Ischemic Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HiCM-188 Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Sep 2026to May 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Complete atrioventricular (AV) conduction block
  • History of left ventricular assist device surgery
  • Other criteria apply. Please contact the investigator for more information.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alex Zhang contact

+1 650 504 5586

Alex.zhang@helptx.com.cn

United States1 site

  • The Texas Heart Institute at Baylor College of Medicine

    Houston, Texas, 77030

    Emerson Perin

Other trials in United States

About this study

Official 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

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 detailed 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.

Being tested
HiCM-188 Cells
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HiCM-188 CellsDrug

    HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

Study groups in NCT07646210
Study groupRoleWhat they receive
HiCM-188 Low DoseExperimentalParticipants 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.
Receives: Drug: HiCM-188 Cells
HiCM-188 High DoseExperimentalParticipants 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.
Receives: Drug: HiCM-188 Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Serious Adverse Events

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

    Measured: Up to 12 months post-transplant

Secondary outcomes (9)

  1. Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI

    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.

    Measured: Baseline, 6 months, and 12 months

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

    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.

    Measured: Baseline, 6 months, and 12 months

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

    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.

    Measured: Baseline, 6 months, and 12 months

  4. Change From Baseline in Infarct Size by Cardiac MRI

    Change from baseline in myocardial infarct size assessed by cardiac MRI.

    Measured: Baseline, 6 months, and 12 months

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

    Change from baseline in myocardial tissue perfusion assessed by positron emission tomography/computed tomography (PET/CT) or single-photon emission computed tomography (SPECT).

    Measured: Baseline, 6 months, and 12 months

  6. Change From Baseline in 6-Minute Walk Distance

    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.

    Measured: Baseline, 6 months, and 12 months

  7. Change From Baseline in New York Heart Association Functional Classification

    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.

    Measured: Baseline, 6 months, and 12 months

  8. Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score

    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.

    Measured: Baseline, 6 months, and 12 months

  9. Incidence of Major Adverse Cardiac Events

    Incidence of major adverse cardiac events (MACE) during the study follow-up period.

    Measured: Up to 12 months post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07646210
Sponsor's protocol ID
HICM188H1101
Status last verified
Jun 2026
First submitted
9 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HiCM-188 Cells in people with Advanced Heart Failure and Ischemic Heart Failure, run by HELP Therapeutics Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex Zhang (+1 650 504 5586, Alex.zhang@helptx.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Serious Adverse Events (time frame: Up to 12 months post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07646210.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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