Severe Cardiomyopathy in Pediatric patietns
Conditions
Interventions
Skeltal muscle is explanted from gastrocnemius of patient lower leg, and myoblasts are isolated. They are cultured at cell processing center and finaly are build up to myoblast sheets. They are implan
Sponsors
Department of Cardiovascular Surgery, Graduate School of medicine, Osaka University
TERUMO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)age of patient is under 18 years old 2)clinical diagnosis of severe cardiomyopathy 3)NYHA functional classification 3 or 4 4)Left ventricular Ejection Fraction is less than 35% 5)Written informed consent of patients themselvesor the parents
Exclusion criteria
Exclusion criteria: Patients who have the foillowings. 1)any degenerative muscle diseases. 2)active infection. 3)suffered from any malignant diseases within 5 years 4)infected by HIV, HBV, HCV or HTLV 5)functional single ventricle physiology 6)restrictive cardiomyopathy 7)irreversible hepatic or renal dysfuntion 8)severe mental retardation or chromosomal abnormality 9)severe pulmonary hyper tension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endopoint is to assess the safty, that is to evaluate adverse events during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are to evaluate serial change of left ventricular function, to confirm successful procedures sheet implantation, and to evaluate QOL of patients. | — |
Countries
Japan
Contacts
Public ContactMasaki Taira
Graduate School of Medicine, Osaka University Department of Cardiovascular Surgery
Outcome results
None listed