Chronic Heart Failure
Conditions
Brief summary
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.
Interventions
BIOLOGICALiPS differentiated cardiomyocytes
Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes
Sponsors
Dongzhimen Hospital, Beijing
Beijing University of Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment | 6 months | 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. |
| Curative effect evaluation | 6 months | 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. |
Countries
China
Outcome results
None listed