Last updated: November 21, 2023
Sponsor: Help Therapeutics
Overall Status: Active - Recruiting
Phase
1
Condition
Congestive Heart Failure
Chest Pain
Coronary Artery Disease
Treatment
Human (allogeneic) iPS-cell-derived cardiomyocyte
Clinical Study ID
NCT05566600
JFYang
Ages 35-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 thetreatment 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 toinclusion evaluation are valid; data collected within 1 month since a myocardialinfarction are invalid).
- Weakening or absence of segmental regional wall motion as determined by standardimaging
Exclusion
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 cardiacdeath.
- Baseline glomerular filtration rate <30ml/min/1.73m2.
- Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times theULN.
- Hematological abnormality: A hematocrit <25% as determined by HCT, white bloodcell<2500/ul or platelet values <100000/ul without another explanation.
- Known, serious radiographic contrast allergy, penicillin allergy, streptomycinallergy.
- 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 bedisease free for 5 years).
- Non-cardiac condition that limits lifespan <1 year.
- On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNFαantagonist.
- 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
Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Human (allogeneic) iPS-cell-derived cardiomyocyte
Phase: 1
Study Start date:
October 09, 2022
Estimated Completion Date:
July 31, 2025
Connect with a study center
The second xiangya hospital of central south university
Changsha, Hunan 410000
ChinaActive - Recruiting
HelpThera
Nanjing, Jiangsu 210000
ChinaSite Not Available

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