Safety and Exploratory Efficacy Study of UCMSCs in Patients With Ischemic Heart Disease (SEESUPIHD)

Study Overview
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Brief Summary
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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.

Conditions
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Acute Myocardial Infarction, Myocardial Infarction, Ischemic Cardiomyopathy

Intervention / Treatment
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* Biological: umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSCs<br>Intracoronary infusion of umbilical cord mesenchymal stem cells (UCMSCs) | Biological: umbilical cord mesenchymal stem cells<br> <br> |
| No Intervention: controls<br>Standard medical treatment without umbilical cord mesenchymal stem cells (UCMSCs) infusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |