Clinical Trial of Human (Allogeneic) iPS Cell-derived Cardiomyocytes Sheet for Ischemic Cardiomyopathy

  • STATUS
    Recruiting
  • End date
    May 30, 2023
  • participants needed
    10
  • sponsor
    Osaka University
Updated on 27 April 2021

Summary

Targeting patients with severe ischemic cardiomyopathy, the purpose of this study is as follows: to confirm short-term efficacy by observing changes and transitions in cardiac function and clinical symptoms compared with each patient's baseline (before and after comparison) by human iPS cell-derived cardiomyocyte sheet transplantation, and to evaluate the safety and tolerability including the combined use of immunosuppressants.

Description

The objective of this study is to confirm the efficacy and safety of a human (allogeneic) iPS cell-derived cardiomyocyte sheet in combination with an immunosuppressant for ischemic cardiomyopathy patients. The primary evaluation items will be improvement of left ventricular systolic function (LVEF) for efficacy, and safety will be assessed by blood tests, general laboratory tests, and other safety-related evaluations. Secondary evaluation items are NYHA functional evaluation, left ventricular remodeling evaluation by echocardiography, hemodynamic evaluation, physical activity function evaluation such as 6MWD and SAS, QOL, and exercise tolerance evaluation by questionnaires.

Details
Condition Coronary Artery Disease, Coronary heart disease, Vascular Diseases, Heart disease, Ischemic Heart Disease, Cardiac Ischemia, Myocardial Ischemia, Cardiac Disease
Treatment Human (allogeneic) iPS cell derived-cardiomyocyte sheet
Clinical Study IdentifierNCT04696328
SponsorOsaka University
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with chronic ischemic heart disease
Patients with Grade III-IV NYHA Functional Classification heart failure
Patients who are in the state of heart failure despite maximal oral medications including digitalis, diuretics, ACE inhibitors, ARBs, beta-blockers, anti-aldosterone drugs, and oral cardiotonics
Patients who are 20 years of age or older at the point of consent
Patients at risk of worsening heart failure despite being under standard surgical treatment (coronary artery bypass surgery, mitral valve angioplasty, left ventricular angioplasty, cardiac resynchronization therapy, and percutaneous coronary intervention) for more than 3 months
Patients with LVEF (Echocardiography) at rest of 35% or less
Patients whose informed consent for clinical trial participation can be obtained from the subject himself/herself in writing
Patients who can continue to visit to the clinical trial site for 52 weeks after obtaining consent, continue to live in Japan, and can be expected to have data collected by NRMD/PMS

Exclusion Criteria

Patients with autoimmune diseases
Patients with allergies or hypersensitivity to the immunosuppressant used
Patients with active infections
Patients who remain in shock due to worsening heart failure
Patients with irreversible organ failure other than heart
Patients with malignant tumors
Patients who are or may be pregnant
Patients with history of alcoholism or drug addiction within six months from the day of consent
Patients with allergies or hypersensitivity to animals such as cattle from which the raw materials are derived
Patients with severe pulmonary hypertension
Patients within 6 months of completion of other clinical trials at the time of enrollment
In addition, patients with other cardiovascular abnormalities who are determined to be unfit for this study as per the judgment of the patient enrollment study committee of physicians
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