Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

Conditions
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Ischemic Cardiomyopathy

Intervention / Treatment
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* Biological: mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 30 to 80 years ischemic cardiomyopathy Left ventricular infarction area seriously low movement to no movement The low whole left ventricular systolic function (LVEF 45% or less) Have line or quasi coronary interventional treatment Willing to accept patients with follow-up evaluation Have signed informed consent form approved by the ethics committee Exclusion Criteria: Non elevation between S-wave and T-wave in patients with acute myocardial infarction No function damage in patients with acute myocardial infarction Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.) Acute infectious diseases Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal Unstable cerebral lesions malignant tumor Cognitive dysfunction and dementia patients, patients with severe mental illness Patients with severe physical disabilities can't regular follow-up Other serious uncontrolled system disease To prepare or have the pregnancy women patients Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy Cannot use the test dose atorvastatin 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) Patients unable or unwilling to sign a consent form

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mesenchymal stem cells<br>Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells. | Biological: mesenchymal stem cells<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The examination of heart function | Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells. | Post cell transplantation: 1, 3, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |