UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

Study Overview
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Brief Summary
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A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation

Detailed Description
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In this study, 40 patients with cardiac insufficiency after acute myocardial infarction were selected and randomly divided into umbilical cord MSCs transplantation treatment group and non-intervention control group to preliminarily observe the safety and effectiveness of MSCs cell transplantation treatment.

Official Title
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Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction

Conditions
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Left Ventricular Dysfunction, Acute Myocardial Infarction

Intervention / Treatment
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* Biological: UC-MSC
* Biological: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade. Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form; Good compliance, willing to take drugs and follow up according to the requirements of the plan; Life expectancy exceeds one year. Exclusion Criteria: Those who cannot tolerate cell therapy; Patients with severe hepatic and renal insufficiency (ALT>1.5 times the upper limit of normal value, Cr >1.5 times the upper limit of normal value); Patients with malignant tumors or extremely weak patients; Patients with severe infection; Patients who are expected to have the second coronary intervention or bypass grafting within 3 months; Patients with other serious systemic diseases and organ dysfunction; Patients with cardiogenic shock; Patients with hemorrhagic diseases; Researchers believe that anyone who is not suitable for inclusion

Ages Eligible for Study
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Minimum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSC<br>UC-MSC transplantation | Biological: UC-MSC<br>* 0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability>80%, and endotoxin<0.1 EU， at the concentration of 2x10(7) cells/ml.<br>* Other names: Transplantation Group;|
| Placebo Comparator: Control Group<br>Routine treatment | Biological: Control Group<br>* Routine treatment without catheter infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured as the number of Major Adverse Cardiac Events (MACE) | Possible adverse events, including adverse events that may occur during angiography and infusion of transplanted cells such as chest pain, arrhythmia, slow blood flow, myocardial injury, fever, allergic reaction, postoperative infection, etc. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up | left ventricular ejection fraction measured by magnetic resonance imaging | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMI