UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03902067
• Other study ID #: ShanghaiLST-ucmsc-ami01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Shanghai Life Science & Technology
• Contact: Chengxing Shen
• Phone: +86-18501664545
• Email: shencx[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Left Ventricular Dysfunction
• Myocardial Infarction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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.
• Control Group
Routine treatment without catheter infusion

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Life Science & Technology	Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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