Clinical trial NCT05566600: Allogeneic iPSC-derived Cardiomyocyte Therapy in Patients With Worsening Ischemic Heart Failure
Official title: Epicardial Injection of Allogeneic Human Pluripotent Stem Cell-derived Cardiomyocytes to Treat Severe Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Ischemic Heart Failure
Chronic Heart Failure
Lead sponsor: Help Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Central South University
First posted: 2022-10-04
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 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.

Primary outcomes:
measure: Safety in terms of the incidence and severity of adverse events
timeFrame: within 1 month post CABG surgery
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1~6 months post CABG surgery
measure: Cardiac assessment
timeFrame: 1~6 months post CABG surgery
measure: Incidence of newly formed tumor
timeFrame: 1~12 months post CABG surgery
measure: Immunogenic assessments
timeFrame: 1 month, 3 months and 6 months post CABG surgery
measure: Changes in left ventricle function evaluation by echocardiogram (ECHO) or cardiac MRI
timeFrame: from baseline to 12 months at 3, 6, and 12 months post CABG surgery
measure: Changes in 6-minute walk test (6MWT)
timeFrame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
measure: Changes in NYHA functional classification
timeFrame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
measure: Changes in quality of life (QoL)
timeFrame: from baseline to 12 months at 1, 3, 6, and 12 months post CABG surgery
measure: Incidence of hospitalization for worsening heart failure
timeFrame: 1~12 months post CABG surgery
Other outcomes:
Locations:
city: Changsha
country: China
facility: The second xiangya hospital of central south university
state: Hunan
city: Nanjing
country: China
facility: HelpThera
state: Jiangsu
Study officials:
References: