HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Alex Zhang
- Telefonnummer: +1 650 504 5586
- E-post: alex.zhang@helptherapeutics.com
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- The Texas Heart Institute at Baylor College of Medicine
-
Huvudutredare:
- Emerson Perin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Serious Adverse Events
Tidsram: Up to 12 months post-transplant
|
Incidence of serious adverse events (SAEs) at 12 months post-transplant |
Up to 12 months post-transplant
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Left Ventricular Ejection Fraction by Cardiac MRI
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Incidence of Major Adverse Cardiac Events
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- HICM188H1101
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