IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure (IDCVTCHF)

Beijing University of Chinese Medicine

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Chronic Heart Failure

Treatments: Biological: iPS differentiated cardiomyocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT03759405

BUCM

Details and patient eligibility

About

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.

Enrollment: 3 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Chronic heart failure treatment group

Experimental group

Description:

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.

Treatment:

Biological: iPS differentiated cardiomyocytes