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

25. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

12

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77030
        • The Texas Heart Institute at Baylor College of Medicine
        • Hovedetterforsker:
          • Emerson Perin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Eksperimentell: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
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
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). The 6-Minute Walk Distance is measured as the distance walked in 6 minutes, with longer distances reflecting better functional exercise capacity.
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. 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.
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). The Minnesota Living With Heart Failure Questionnaire score ranges from 0 to 105, with higher scores reflecting worse heart failure-related quality of life.
Baseline, 6 months, and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

HELP Therapeutics Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • HICM188H1101

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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