A Phase 1 interventional study of hiPSC-CM therapy in Cardiovascular Diseases, Congestive Heart Failure and Dilated Cardiomyopathy, sponsored by Help Therapeutics. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-23.
Sponsored by Help Therapeutics · Phase 1, Interventional, and Treatment
Heart failure is the primary cause of morbidity and mortality worldwide. Currently drug treatments for heart failure manage the symptoms, but not restore the loss cardiomyocytes due to the very limited regenerative capability in the adult heart. Novel reparative therapies that replace the cardiomyocytes loss are highly demanded to restore the cardiac function. The main purposes of this explanatory study is to investigate the safety and efficacy of the catheter-based endocardial delivery of human iPSC-derived cardiomyocytes in patients with congestive heart failure.
Patients with severe congestive heart failure will be treated with allogeneic human iPSC-derived cardiomyocytes (HiCM-188) through the catheter-based injections. HiCM188, produced by Help therapeutics with cGMP condition, will be transplanted into the myocardium through a transcatheter endocardial injection system with two dosage (100 million cells or 400 million cells). The safety and efficacy assessments will be conducted at1, 3, 6 and 12 months after the cell transplantation.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Help Therapeutics is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Biological: hiPSC-CM therapy
Biological: hiPSC-CM therapy
20 patients with congestive heart failure who met the inclusion and exclusion criteria will be recruited. After being fully informed and signed the informed consent, the patients will be randomly divided into two dosage groups: 100 million cells (10 patients) and 400 million cells (10 patients). Human iPSC-derived cardiomyocytes will be injected into the myocardium through a transcatheter endocardial injection system.
Incidence of major serious adverse events (SAEs)
Incidence of SAEs is defined as the composite of: death, fatal myocardial infarction, stroke, tamponade, cardiac perforation, ventricular arrhythmias affecting hemodynamics (\> 15s), and tumorigenicity related to the hiPSC-CM .
Time frame: First month post-catheterization
Incidence of severe arrhythmia
Clinically significant arrhythmias will be recorded by 24-hour ambulatory electrocardiogram
Time frame: 1-6 months post-catheterization
Incidence of newly formed tumors
by comparing chest, abdominal and pelvic CT scan and PET-CT scan
Time frame: Baseline, 1,3,6 and 12 months post-catheterization
Changes in penal reactive antibodies (PRA)
Changes in penal reactive antibodies (PRA) as assessed via blooddraw
Time frame: Baseline, 1, 3 and 6 months post-catheterization
Changes in donor specific antibodies (DSA)
Changes in donor specific antibodies (DSA) as assessed via blooddraw
Time frame: Baseline, 1, 3 and 6 months post-catheterization
Overall Left Ventricular systolic performance as assessed by MRI
Left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDV), left ventricular end-systolic dimension (LVESV), evaluated and compared to baseline values.
Time frame: Baseline, 1, 3, 6 and 12 months post-catheterization
Overall Left Ventricular systolic performance as assessed by PET/ECT Scan
Myocardial contraction and relaxation and myocardial perfusion, evaluated and compared to baseline values.
Time frame: Baseline, 6 and 12 months post-catheterization
Functional status by 6 minute walk test
valuate Functional Capacity via the Six Minute Walk Test
Time frame: Baseline, 1,3,6 and 12 months post-catheterization
Functional status by New York Heart Association (NYHA) Classification
Evaluate Functional Capacity via New York Heart Association (NYHA) Class Determination
Time frame: Baseline, 1,3,6 and 12 months post-catheterization
Minnesota Living With Heart Failure Questionnaire (MLHFQ)
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.
Time frame: Baseline, 1,3,6 and 12 months post-catheterization
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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