Dilated cardiomyopathy, Ischemic cardiomyopathy
Conditions
Interventions
Culture of autologous skeletal myoblasts and engineering myoblast sheets. Transplantation of myoblast sheets to heart
Patients with maximal medical and surgical treatment
Sponsors
Osaka University Graduate School of Medicine, Cardiovascular surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Dilated cardiomyopathy and ischemic cardiomyopathy 2) NYHA Class II,III, IV 3) Ejection fraction<35%
Exclusion criteria
Exclusion criteria: 1) Severe skeletal muscle disease 2) Severe infection 3) Alcoholic or drug addiction in recent six months 4) Malignancy 5) Virus infection (HIV, HBV, HCV,HTLV) 6) Pregnancy 7) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of LV ejection fraction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Feasibility of myoblast sheet implantation 2) Improvement of regional function 3) LV reverse remodeling 4) Improvement of symptoms and grade of heart failure 5) Adverse event | — |
Countries
Japan
Contacts
Public ContactShigeru Miyagawa
Osaka University Graduate School of Medicine Cardiovascular surgery
Outcome results
None listed