Trial | NCT03902067  Report issue

Title

UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Not yet recruiting

  • Intervention/Treatment

    UC-MSC ...

  • Study Participants

    40
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
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.
Study Started
Dec 01
2023
Anticipated
Primary Completion
Dec 31
2025
Anticipated
Study Completion
Dec 31
2025
Anticipated
Last Update
Apr 12
2023

Biological UC-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.

  • Other names: Transplantation Group

Biological Control Group

Routine treatment without catheter infusion

UC-MSC Experimental

UC-MSC transplantation

Control Group Placebo Comparator

Routine treatment

Criteria 

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
No Results Posted