Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure

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

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.

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
    China

    Active - Recruiting

  • HelpThera

    Nanjing, Jiangsu 210000
    China

    Site Not Available

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