Acute Myocardial Infarction, Left Ventricular Dysfunction
Conditions
Keywords
AMI
Brief summary
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
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.
Interventions
BIOLOGICALUC-MSC
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.
BIOLOGICALControl Group
Routine treatment without catheter infusion
Sponsors
Shanghai Life Science & Technology
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured as the number of Major Adverse Cardiac Events (MACE) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up | 12 months | left ventricular ejection fraction measured by magnetic resonance imaging |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChengxing Shen, Dr.
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Outcome results
None listed