Acute Myocardial Infarction, Ischemic Cardiomyopathy, Myocardial Infarction
Conditions
Brief summary
The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.
Interventions
BIOLOGICALumbilical cord mesenchymal stem cells
Sponsors
Sun Yat-sen University
South China Research Center for Stem Cell and Regenerative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery; * LVEF (left ventricular ejection fraction): 25-45%; * Age between 18 and 70, borh gender; * Women of childbearing age agreed to take contraceptive measures during the whole study period; * No psychiatric illnesses and speaking dysfunction; * Informed consent.
Exclusion criteria
* Structural heart disease, Valvular heart disease, Refractory hypertension(Unstable blood pressure control), LVEF\<24%; * Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamic-oxaloacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value; * Patients suffered from severe arrhythmia; * Patients suffered from stent thrombosis; * Patients receiving immunosuppressive therapy; * Patients have tumor or other lethal diseases (expectation of life\<6 months); * Women who plan to be pregnant or are pregnant or nursing; * Allergic constitution(Allergic to more than two kinds of drugs,food, or pollen); * Other clinical trial participants within 3 months; * Investigators judge other conditions not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in global left ventricular ejection fraction (LVEF)measured by echocardiography. | 1 week, 6 month, 12 month,18 month |
| Change in infarct size and myocardial viability within the infarcted region measured by emission computed tomography (ECT). | 1 week, 18 month |
Secondary
| Measure | Time frame |
|---|---|
| Pump failure Killip classification | baseline, 1 week, 1 month, 6 month, 12 month,18 month |
| New York Heart Association(NYHA) classification | 1 week, 1 month, 6 month, 12 month,18 month |
| Occurrence of major adverse event | 3 day, 1 week, 1 month, 6 month, 12 month,18 month |
Contacts
Primary ContactXuetao Pei, M.D., Ph.D
Backup ContactJunnian Zhou, Ph.D
Outcome results
None listed