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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05566600
Other study ID # JFYang
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 9, 2022
Est. completion date July 31, 2025

Study information

Verified date November 2023
Source Help Therapeutics
Contact Jiaxian Wang
Phone +86-18565616060
Email wangjx@helpsci.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of allogeneic induced pluripotent cell derived cardiomyocytes (iPSC-CMs) in treating patients with worsening ischemic heart failure undergoing coronary artery bypass graft surgery. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date July 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 35 Years to 75 Years
Eligibility Inclusion Criteria: - Aged 35-75 (including 35 and 75). - 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: - 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. - On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFa 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.

Study Design


Intervention

Biological:
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

Locations

Country Name City State
China The second xiangya hospital of central south university Changsha Hunan
China HelpThera Nanjing Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Help Therapeutics Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety in terms of the incidence and severity of adverse events Number of participants with death, fatal myocardial infarction, stroke, ventricular tachycardia sustained for >15 seconds and newly formed tumor within 1 month post CABG surgery
Secondary Incidence of adverse events Adverse events that require medical intervention 1~6 months post CABG surgery
Secondary Cardiac assessment 24-hour Holter Monitoring post the CABG surgery 1~6 months post CABG surgery
Secondary Incidence of newly formed tumor Evaluation by chest, abdominal and pelvic CT scan and PET-CT scan 1~12 months post CABG surgery
Secondary Immunogenic assessments Donor specific antibody (DSA), serum anti-human leukocyte antigens (anti-HLA) antibody/panel-reactive antibody (PRA) serology monitoring 1 month, 3 months and 6 months post CABG surgery
Secondary Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI Changes in cardiac function will be assessed by left ventricular end-systolic volume (LVESV, mL) changes from baseline to 12 months post surgery from baseline to 12 months at 3, 6, and 12 months post CABG surgery
Secondary Changes in 6-minute walk test (6MWT) from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Secondary Changes in NYHA functional classification from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Secondary Changes in quality of life (QoL) Quality of life changes as measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ) scores from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
Secondary Incidence of hospitalization for worsening heart failure 1~12 months post CABG surgery
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