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

9. juni 2026 opdateret af: HELP Therapeutics Co., Ltd.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • The Texas Heart Institute at Baylor College of Medicine
        • Ledende efterforsker:
          • Emerson Perin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: HiCM-188 Cells
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
Eksperimentel: 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.
Medicin: HiCM-188 Cells
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Serious Adverse Events
Tidsramme: Up to 12 months post-transplant
Incidence of serious adverse events (SAEs) at 12 months post-transplant
Up to 12 months post-transplant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
Tidsramme: 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.
Baseline, 6 months, and 12 months
Change From Baseline in Left Ventricular End-Diastolic Volume by Cardiac MRI
Tidsramme: 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.
Baseline, 6 months, and 12 months
Change From Baseline in Left Ventricular End-Systolic Volume by Cardiac MRI
Tidsramme: 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.
Baseline, 6 months, and 12 months
Change From Baseline in Infarct Size by Cardiac MRI
Tidsramme: Baseline, 6 months, and 12 months
Change from baseline in myocardial infarct size assessed by cardiac MRI.
Baseline, 6 months, and 12 months
Change From Baseline in Myocardial Tissue Perfusion by PET/CT or SPECT
Tidsramme: 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).
Baseline, 6 months, and 12 months
Change From Baseline in 6-Minute Walk Distance
Tidsramme: Baseline, 6 months, and 12 months
Change from baseline in exercise capacity as assessed by the 6-minute walk distance (6MWD).
Baseline, 6 months, and 12 months
Change From Baseline in New York Heart Association Functional Classification
Tidsramme: Baseline, 6 months, and 12 months
Change from baseline in New York Heart Association (NYHA) functional classification.
Baseline, 6 months, and 12 months
Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score
Tidsramme: Baseline, 6 months, and 12 months
Change from baseline in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Baseline, 6 months, and 12 months
Incidence of Major Adverse Cardiac Events
Tidsramme: Up to 12 months post-transplant
Incidence of major adverse cardiac events (MACE) during the study follow-up period.
Up to 12 months post-transplant

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HELP Therapeutics Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HICM188H1101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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