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

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

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.

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.

Inclusion Criteria:

1. Patients with chronic ischemic heart disease
2. Patients with Grade III-IV NYHA Functional Classification heart failure
3. 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
4. Patients who are 20 years of age or older at the point of consent
5. 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
6. Patients with LVEF (Echocardiography) at rest of 35% or less
7. Patients whose informed consent for clinical trial participation can be obtained from the subject himself/herself in writing
8. 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:

1. Patients with autoimmune diseases
2. Patients with allergies or hypersensitivity to the immunosuppressant used
3. Patients with active infections
4. Patients who remain in shock due to worsening heart failure
5. Patients with irreversible organ failure other than heart
6. Patients with malignant tumors
7. Patients who are or may be pregnant
8. Patients with history of alcoholism or drug addiction within six months from the day of consent
9. Patients with allergies or hypersensitivity to animals such as cattle from which the raw materials are derived
10. Patients with severe pulmonary hypertension
11. Patients within 6 months of completion of other clinical trials at the time of enrollment
12. 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