UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

Phase 1

Not yet recruiting

• Conditions: Left Ventricular Dysfunction; Acute Myocardial Infarction
• Interventions: Biological: UC-MSC; Biological: Control Group

• Registration Number: NCT03902067
• Lead Sponsor: Shanghai Life Science & Technology

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.

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Status Verified: 2023-10
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC-MSC	UC-MSC	UC-MSC transplantation
Control Group	Control Group	Routine treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China