Implement of Autologous Skeletal Myoblast Cell Sheet Transplantation for Dilated Cardio myopathy aiming Precision Medicine (Imple ment of Autologous Skeletal Myoblast Cell Sheet Transplantation for Dilated Cardiomyo pathy aiming Precision Medicine)

miyagawa shigeru0 sites4 target enrollmentFebruary 9, 2021

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

miyagawa shigeru

•1\)Diagnosed with dilated cardiomyopathy
•2\)Participate in a series of studies including genetic analysis
•3\)Suffering from heart failure of NYHA class III or IV
•4\)Worsening heart failure despite receiving maximum medical therapy such as digitalis, diuretic, angiotensin converting enzyme inhibitor, angiotensin II receptor blocker, beta blocker, aldosterone antagonist, and oral inotropic agents
•5\)16 years of age or older when at the time of informed consent
•6\)Concerned worsening heart failure despite receiving the standard surgical treatment (left ventricular reconstruction, mitral valve procedure, and so on) and medical treatment over 3 months ago
•7\)Left ventricular ejection fraction of \<\=35% in echocardiography at rest from the past 3 months before the informed consent to the enrollment
•8\)Patients who can consent to participate in this regenerative therapy research in writing by themselves or patients and their guardians can inform consent if they are minor

•1\)Having symptoms of musculoskeletal disease
•2\)Infected with HIV, HBV, HCV, or HTLV\-1
•3\)Cardiogenic shock due to worsening heart failure
•4\)Having irreversible organ failure other than their hearts
•5\)Having malignant tumor
•6\)Pregnant or possibility of pregnant
•7\)Refusal of transfusion
•8\)Having past history of drug or alcohol addiction in the past 6 months before the informed consent
•9\)Allergy of antibiotics or raw material of animal origin such as fetal bovine serum
•10\)Having severe pulmonary hypertension

Not specified