Status:
UNKNOWN
Clinical Trial of Human (Allogeneic) iPS Cell-derived Cardiomyocytes Sheet for Ischemic Cardiomyopathy
Lead Sponsor:
Osaka University
Collaborating Sponsors:
Cuorips Inc.
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 sy...
Detailed 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 pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04696328
Start Date
December 2 2019
End Date
May 30 2023
Last Update
April 20 2021
Active Locations (1)
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1
Osaka University Hospital
Suita, Osaka, Japan, 5650871