Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.
- Conditions
- Severe heart failure due to chronic ischemic heart disease
- Registration Number
- JPRN-UMIN000008013
- Lead Sponsor
- Terumo Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
(1) Patients who have signs of skeletal muscle disease. (2) Patients under treatment with thyroid hormone. (3) Patients with infectious disease(HIV,HBV,HCV,HTLV1). (4) Patients in shock due to worsening heart failure. (5) Patients with intercurrent cardiovascular abnormalities that are judged to affect the clinical trial by the investigator or the sub investigators. (6) Patients with irreversible organ failure other than the heart. (7) Patients with a malignant tumor. (8) Patients who are pregnant or possibly pregnant. (9) Patients who cannot receive a blood transfusion. (10) Patients with a history of drug addiction or alcohol addiction within 6 months before obtaining informed consent.(11) Patients with hypersensitivity to antibiotics or animal origin materials such as fetal bovine serum. (12) Patients with severe pulmonary hypertension. (13) Patients with a history of other clinical study within 6 months. (14) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in LVEF at 26 weeks after the transplantation.
- Secondary Outcome Measures
Name Time Method