Treating Heart Failure With hiPSC-CMs
Epicardial Injection of Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
1 other identifier
interventional
20
1 country
1
Brief Summary
Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 heart-failure
Started Jun 2022
Typical duration for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 22, 2023
November 1, 2023
3.5 years
December 22, 2021
November 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery.
Incidence of serious adverse events(SAEs) within 1 month post-CABG surgery. These include death, fatal myocardial infarction, stroke, cardiac tamponade, cardiac perforation, hemodynamic ventricular arrhythmias (duration \> 15s), and new allogeneic human neoplasms.
1 Month Post-operation
Secondary Outcomes (20)
Size of infracted myocardium assessed by MRI
Baseline, 1, 3, 6 and 12 Months Post-operation
Left Ventricular systolic performance as assessed by MRI
Baseline, 1, 3, 6 and 12 Months Post-operation
Left ventricular ejection fraction assessed by MRI
Baseline, 1, 3, 6 and 12 Months Post-operation
Overall Left Ventricular systolic performance as assessed by MRI
Baseline, 1, 3, 6 and 12 Months Post-operation
Cardiac output assessed by MRI
Baseline, 1, 3, 6 and 12 Months Post-operation
- +15 more secondary outcomes
Study Arms (2)
hiPSC-CM therapy
EXPERIMENTALInjection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 100 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.
Control
SHAM COMPARATORCoronary artery bypass grafting surgery only.
Interventions
Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 100 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.
Eligibility Criteria
You may qualify if:
- Aged 35-75 (including 35 and 75).
- Have signed the Informed Consent Form (ICF).
- Patients have chronic left ventricular dysfunction.
- Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
- Patients have indications for Coronary Artery Bypass Grafting.
- Weakening or absence of segmental regional wall motion as determined by standard imaging.
You may not qualify if:
- PRA ≥ 20% or DSA-positive.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Help Therapeuticslead
- Shanghai East Hospitalcollaborator
Study Sites (1)
Shanghai east Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongmin Liu, MD,phD
Shanghai East Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2021
First Posted
February 4, 2022
Study Start
June 30, 2022
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share