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

Primary Purpose

Chronic Heart Failure

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
iPS differentiated cardiomyocytes
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic heart failure treatment group

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2018
Last Updated
July 20, 2022
Sponsor
Beijing University of Chinese Medicine
Collaborators
Dongzhimen Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT03759405
Brief Title
IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure
Acronym
IDCVTCHF
Official Title
Myocardial Cell Vein Transplantation for Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine
Collaborators
Dongzhimen Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chronic heart failure treatment group
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
iPS differentiated cardiomyocytes
Intervention Description
Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes
Primary Outcome Measure Information:
Title
Quality of life assessment
Description
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.
Time Frame
6 months
Title
Curative effect evaluation
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

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