Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure
NCT ID: NCT05566600
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
32 participants
INTERVENTIONAL
2022-10-09
2025-07-31
Brief Summary
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After screening, iPSC-CMs will be administrated intramyocardially in consented and eligible patients undergoing open-chest CABG surgery and the estimated population size for the study will be 32 patients.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose level 1
100 million iPSC-CMs administration
Human (allogeneic) iPS-cell-derived cardiomyocyte
10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
Dose level 2
200 million iPSC-CMs administration
Human (allogeneic) iPS-cell-derived cardiomyocyte
10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
Dose level 3
400 million iPSC-CMs administration
Human (allogeneic) iPS-cell-derived cardiomyocyte
10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
Control
Participants will received CABG surgery only
No interventions assigned to this group
Interventions
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Human (allogeneic) iPS-cell-derived cardiomyocyte
10-20 epicardial injections (0.25 mL each) of iPSC-CMs will be delivered in the border zone of the infarcted myocardium
Eligibility Criteria
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Inclusion Criteria
* Signed the Informed Consent Form (ICF).
* Have chronic left ventricular dysfunction.
* Have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
* Have indications for Coronary Artery Bypass Grafting.
* LVEF \< 40% as determined by echocardiogram (data collected up to 6 months prior to inclusion evaluation are valid; data collected within 1 month since a myocardial infarction are invalid).
* Weakening or absence of segmental regional wall motion as determined by standard imaging
Exclusion Criteria
* Patient received ICD transplantation, CRT or similar treatment.
* Patients with valvular heart disease or received heart valvular disease
* Patients received treatment of percutaneous transluminal coronary intervention (PCI)
* Patients with atrial fibrillation
* Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
* Baseline glomerular filtration rate \<30ml/min/1.73m2.
* Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
* Hematological abnormality: A hematocrit \<25% as determined by HCT, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation.
* Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
* Coagulopathy (INR\>1.3) not due to a reversible cause.
* Contra-indication to performance of a MRI scan.
* Recipients of organ transplant.
* Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
* Non-cardiac condition that limits lifespan \<1 year.
* On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFα antagonist.
* Patients allergy to or cannot use immunosuppressant.
* Serum positive for HIV, HBV, HCV, TP.
* Currently enrolled other investigational therapeutic or device study.
* Patients who are pregnant or breast feeding.
* Other conditions that researchers consider not suitable to participate in this study.
35 Years
75 Years
ALL
No
Sponsors
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Central South University
OTHER
Help Therapeutics
INDUSTRY
Responsible Party
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Locations
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The second xiangya hospital of central south university
Changsha, Hunan, China
HelpThera
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Chengming Fan
Role: primary
Other Identifiers
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JFYang
Identifier Type: -
Identifier Source: org_study_id