IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

NCT ID: NCT03759405

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-12-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic heart failure treatment group

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.

Group Type: EXPERIMENTAL

iPS differentiated cardiomyocytes

Intervention Type: BIOLOGICAL

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

Interventions

iPS differentiated cardiomyocytes

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: collaborator

Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Anlong Xu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BUCM

Identifier Type: -

Identifier Source: org_study_id