Treating Heart Failure With hiPSC-CMs

Last updated: November 21, 2023
Sponsor: Help Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Congestive Heart Failure

Chest Pain

Hyponatremia

Treatment

Control

hiPSC-CM therapy

Clinical Study ID

NCT05223894
ZMLiu
  • Ages 35-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 35-75 (including 35 and 75).
  2. Have signed the Informed Consent Form (ICF).
  3. Patients have chronic left ventricular dysfunction.
  4. Patients have NYHA Class III-IV cardiac function even after improved medication forthe treatment of advanced chronic heart failure.
  5. Patients have indications for Coronary Artery Bypass Grafting.
  6. 20% ≤ LVEF ≤ 40% as determined by echocardiogram (data collected up to 3 months priorto inclusion evaluation are valid; data collected within 1 month since a myocardialinfarction are invalid).
  7. Weakening or absence of segmental regional wall motion as determined by standardimaging.

Exclusion

Exclusion Criteria:

  1. PRA ≥ 20% or DSA-positive.
  2. Patient received ICD transplantation, CRT or similar treatment.
  3. Patients with valvular heart disease or received heart valvular disease
  4. Patients received treatment of percutaneous transluminal coronary intervention (PCI)
  5. Patients with atrial fibrillation
  6. Patients previously suffered sustained ventricular tachycardia or sudden cardiacdeath.
  7. Baseline glomerular filtration rate <30ml/min/1.73m2.
  8. Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times theULN.
  9. Hematological abnormality: A hematocrit <25% as determined by HCT, white bloodcell<2500/ul or platelet values <100000/ul without another explanation.
  10. Known, serious radiographic contrast allergy, penicillin allergy, streptomycinallergy.
  11. Coagulopathy (INR>1.3) not due to a reversible cause.
  12. Contra-indication to performance of a MRI scan.
  13. Recipients of organ transplant.
  14. Clinical history of malignancy within 5 years (patients with prior malignancy must bedisease free for 5 years).
  15. Non-cardiac condition that limits lifespan <1 year.
  16. On chronic therapy with immunosuppressant medication, such as glucocorticoid and TNF-αantagonist.
  17. Patients allergy to or cannot use immunosuppressant.
  18. Serum positive for HIV, HBV, HCV, TP.
  19. Currently enrolled other investigational therapeutic or device study.
  20. Patients who are pregnant or breast feeding.
  21. Other conditions that researchers consider not suitable to participate in this study.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Control
Phase: 1/2
Study Start date:
June 30, 2022
Estimated Completion Date:
December 30, 2025

Study 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 at time of coronary artery bypass grafting. Patients will be assessed at 1, 3, 6 and 12 months after cell transplantation for safety and efficacy.

Connect with a study center

  • Shanghai east Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

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