Myocardial Cell Vein Transplantation for Chronic Heart Failure
| Registry | NCT03759405, acronym IDCVTCHF |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 3 (Estimated) |
| Sponsor | Beijing University of Chinese Medicine (Other); collaborators: Dongzhimen Hospital, Beijing |
| Conditions | Chronic Heart Failure |
| Interventions | iPS differentiated cardiomyocytes (Biological) |
| Dates | start 2022-12-31 (estimated), primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2018-11-30, last updated 2022-07-22 |
| Locations | 1 site in China |
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All trials for Chronic Heart Failure All trials of iPS differentiated cardiomyocytes
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Chronic heart failure treatment group | Experimental | Biological: iPS differentiated cardiomyocytes | 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. |
Sex: All, ages: 30 Years to 80 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing University of Chinese Medicine | Beijing, Beijing Municipality | China |