Ischemic Cardiomyopathy
Conditions
Brief summary
The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Detailed description
Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .
Interventions
BIOLOGICALmesenchymal stem cells
Procedure: Selected patients were randomly divided into a cell therapy group and a control group. Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age from 30 to 80 years 2. ischemic cardiomyopathy 3. Left ventricular infarction area seriously low movement to no movement 4. The low whole left ventricular systolic function (LVEF 45% or less) 5. Have line or quasi coronary interventional treatment 6. Willing to accept patients with follow-up evaluation 7. Have signed informed consent form approved by the ethics committee
Exclusion criteria
1. Non elevation between S-wave and T-wave in patients with acute myocardial infarction 2. No function damage in patients with acute myocardial infarction 3. Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery 4. Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.) 5. Acute infectious diseases 6. Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc 7. Severe renal disease, creatinine clearance \< 36 ml/min, serum creatinine \> 265 umol/L 8. Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) \> 4 times the upper limit of normal 9. Unstable cerebral lesions 10. malignant tumor 11. Cognitive dysfunction and dementia patients, patients with severe mental illness 12. Patients with severe physical disabilities can't regular follow-up 13. Other serious uncontrolled system disease 14. To prepare or have the pregnancy women patients 15. Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy 16. Cannot use the test dose atorvastatin 17. Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint) 18. Patients unable or unwilling to sign a consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The examination of heart function | Post cell transplantation: 1, 3, 6 months | Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells. |
Secondary
| Measure | Time frame |
|---|---|
| all-cause mortality | Post cell transplantation: one year |
| all-cause morbidity | Post cell transplantation: one year |
| major adverse cardiac and cerebrovascular events | Post cell transplantation: one year |
Countries
China
Outcome results
None listed