IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

Study Overview
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Brief Summary
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Based on the safety evaluation of primates, the best cell transplantation scheme was integrated. One patient with CHF caused by coronary heart disease, one patient with CHF caused by dilatation and one patient with CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The safety evaluation of human body was completed and combined with subjective and objective indexes respectively. Structural and functional indicators were used to evaluate the therapeutic effect of cell transplantation. The results of animal experiments confirmed the safety and effectiveness of intravenous myocardial cell transplantation, and clarified its possible mechanism.

Official Title
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Myocardial Cell Vein Transplantation for Chronic Heart Failure

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Biological: iPS differentiated cardiomyocytes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: It accords with the diagnostic standard of chronic heart failure. The etiological diagnosis accords with the corresponding diagnostic standard. The age is 30 80 years old. Cardiac function classification is III- grade IV. Signed informed consent. Exclusion Criteria: Those who did not meet the diagnostic criteria and were included in the standard. Patients with severe dyspnea (such as COPD with pulmonary encephalopathy, upper gastrointestinal bleeding, etc.) accompanied by obvious hypoxemia and hemodynamic instability. Patients with severe primary diseases, such as liver and kidney diseases, hematological diseases, autoimmune diseases, malignant tumors, progressive diseases or diseases with poor prognosis, such as severe infection, severe water and electrolyte disorders, acid-base imbalance. Various infectious diseases. Participants in other clinical trials in the past two months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic heart failure treatment group<br>One case of CHF caused by coronary heart disease, one case of CHF caused by dilated heart disease and one case of CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. | Biological: iPS differentiated cardiomyocytes<br>* Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life assessment | Minnesota Heart Failure Scale for Quality of Life. Scale ranges (0-100), do higher values represent a worse outcome. The higher the score, the lower the quality of life. | 6 months | 
| Curative effect evaluation | Cardiac Function Measurement by Cardiac Color Doppler Ultrasound. Under normal conditions, left ventricular ejection fraction is more than 50%. The lower ejection fraction, the worse heart function. | 6 months |