Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy

UMIN ID: UMIN000032989

Registered date:15/06/2018

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ischemic cardiomyopathy
• Date of first enrollment: 2019/08/11
• Target sample size: 3
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation

Outcome(s)

• Primary Outcome: Feasibility and safety evaluation of human (allogeneic) iPS cell derived-cardiomyocyte sheet transplantation (presence / absence, type, severity, frequency of expression and duration of adverse event accompanying iPS cell derived-cardiomyocyte sheet transplantation)
• Secondary Outcome: Evaluation of LVEF, left ventricular remodeling, severity of symptoms of heart failure from protocol treatment to 1 year after protocol treatment

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 79years-old
• Gender: Male and Female
• Exclude criteria: 1)Severe infection. 2)Alcoholic or drug addiction in recent six months 3)Malignancy 4)Virus infection(HIV,HBV,HCV,HTLV) 5)Pregnancy 6)Hypersensitivity 7)Contraindication(Immunosuppressant) 8)Others

Related Information

• Primary Sponsor: Osaka University
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): PA8170002