Treating Heart Failure With hPSC-CMs
- Conditions
- Heart Failure
- Interventions
- Biological: hPSC-CM Therapy
- Registration Number
- NCT03763136
- Lead Sponsor
- Help Therapeutics
- 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 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, feasibility and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.
- 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 at time of coronary artery bypass grafting. Patients will be assessed at 1, 3, 6 and 12 months after cell transplantation for safety, feasibility and efficacy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hPSC-CM Therapy hPSC-CM Therapy Procedure: Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 200 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium. Control hPSC-CM Therapy Procedure: Coronary artery bypass grafting surgery only.
- Primary Outcome Measures
Name Time Method Incidence of sustained ventricular arrhythmias 1~6 Month Post-operation defined as the proportion of patients experiencing ventricular arrhythmias lasting more than 30 seconds
Incidence of newly formed tumors 1~6 Month Post-operation by comparing chest, abdominal and pelvic CT scan and PET-CT scan
- Secondary Outcome Measures
Name Time Method Functional status by 6 minute walk test Baseline, 1, 3, 6 and 12 Months Post-operation Evaluate Functional Capacity via the Six Minute Walk Test
Overall Left Ventricular systolic performance as assessed by PET/ECT Scan Baseline, 6 and 12 Months Post-operation Myocardium perfusion
Changes in cytokines Baseline,1, 3, 6 and 12 Months Post-operation Change in NT-proBNP as assessed via blooddraw
Overall Left Ventricular systolic performance as assessed by MRI Baseline, 1, 3, 6 and 12 Months Post-operation Size of infracted myocardium, left ventricular side wall thickness at diastolic, interventricular septum thickness, left ventricular ejection fraction, left ventricular end-systolic volume and end-diastolic volume, stroke volume, cardiac output, myocardium density and left ventricular mass at diastolic will be evaluated and compared to baseline values.
Functional status by New York Heart Association (NYHA) Classification Baseline, 1, 3, 6 and 12 Months Post-operation Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
Minnesota Living With Heart Failure Questionnaire (MLHFQ) Baseline, 1, 3, 6 and 12 Months Post-operation Evaluate Quality Of Life Changes via Minnesota Living with Heart Failure (MLHF). The Maximum possible scores being 105 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.
Incidence of Serious Adverse Events (SAE) Baseline, 1~12 Months Post-operation SAE justified (all undesirable or unintended diseases or laboratory and imaging disorders and symptoms that occur in subjects after CABG surgery and 12 months postoperative follow-up, or until the subject withdrawals from the study. AE grading will be based on Common Terminology Criteria for Adverse Events (CTCAE) V5.0.)
Overall Left Ventricular systolic performance as assessed by Echocardiogram Baseline, 1, 3, 6 and 12 Months Post-operation Interventricular septum thickness at diastolic, left ventricular end-systolic diameter and end-diastolic diameter, left ventricular posterior wall thickness at diastolic, left atrial diameter, left ventricular ejection fraction, mitral flow pattern (E/A) will be evaluated and compared to baseline values.
Incidence of Major Adverse Cardiac Events (MACE) Baseline, 1~12 Months Post-operation Major Adverse Cardiac Events (MACE), defined as the composite incidence of (1) death, (2) non-lethal myocardial infraction, and (3) hospitalization for worsening HF
Changes in penal reactive antibodies (PRA) Baseline, 1, 3, 6 and 12 Months Post-operation Changes in penal reactive antibodies (PRA) as assessed via blooddraw
Changes in donor specific antibodies (DSA) Baseline, 1, 3, 6 and 12 Months Post-operation Changes in donor specific antibodies (DSA) as assessed via blooddraw
Incidence of severe arrhythmia First month post-operatively Clinically significant arrhythmias will be recorded by Electrocardiogram monitoring
Trial Locations
- Locations (1)
HelpThera
🇨🇳Nanjing, Jiangsu, China