IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

Phase 2

Not yet recruiting

• Conditions: Chronic Heart Failure
• Interventions: Biological: iPS differentiated cardiomyocytes

• Registration Number: NCT03759405
• Lead Sponsor: Beijing University of Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22
• Study Start: 2022-12-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic heart failure treatment group	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China