IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

Chronic Heart Failure Clinical Trial

— IDCVTCHF  

Official title:

Myocardial Cell Vein Transplantation for Chronic Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03759405
• Other study ID #: BUCM
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 31, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Biological:
• iPS differentiated cardiomyocytes
Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes

Locations

Country	Name	City	State
China	Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine	Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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