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)

Phase 3

Suspended

• Conditions: dilated cardiomyopathy

• Registration Number: JPRN-jRCTb050200131
• Lead Sponsor: miyagawa shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-09
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

Exclusion Criteria

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
11)Participation in another clinical trial(except for the programing device) or intervention in the past 6 months
12)Patients judged inappropriate to participate in this regenerative therapy with any reasons by the principal investigator or subinvestigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified