HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
25 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
12
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Alex Zhang
- Numéro de téléphone: +1 650 504 5586
- E-mail: Alex.zhang@helptx.com.cn
Lieux d'étude
-
-
Texas
-
Houston, Texas, États-Unis, 77030
- The Texas Heart Institute at Baylor College of Medicine
-
Chercheur principal:
- Emerson Perin
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
|
|
Expérimental: 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.
|
HiCM-188 is an investigational allogeneic human induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy administered as intramyocardial injection during CABG surgery.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Serious Adverse Events
Délai: Up to 12 months post-transplant
|
Incidence of serious adverse events (SAEs) at 12 months post-transplant
|
Up to 12 months post-transplant
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 mai 2028
Achèvement de l'étude (Estimé)
1 mai 2028
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
25 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- HICM188H1101
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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