IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

NCT03759405 | Unknown Phase 2 DMC

• 1 other identifier: BUCM
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Chronic heart failure treatment group

EXPERIMENTAL

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.

Biological: iPS differentiated cardiomyocytes

Interventions

iPS differentiated cardiomyocytes BIOLOGICAL

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

Chronic heart failure treatment group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead
• Dongzhimen Hospital, Beijing: collaborator

Study Sites (1)

Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 30, 2018
• Study Start: December 31, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)