Status:
COMPLETED
Treating Heart Failure With hPSC-CMs
Lead Sponsor:
Help Therapeutics
Collaborating Sponsors:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Heart Failure
Eligibility:
All Genders
35-75 years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
Patients with heart failure will be treated with allogenic human pluripotent stem cell-derived cardiomyocytes ( hPSC-CM ) from healthy donors. The cells will be injected directly into the myocardium a...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- 20% ≤ LVEF ≤ 45% 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 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.
Exclusion
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03763136
Start Date
October 8 2021
End Date
October 30 2024
Last Update
August 22 2025
Active Locations (1)
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1
HelpThera
Nanjing, Jiangsu, China, 210000