UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

Shanghai Life Science & Technology

Status and phase: Not yet enrolling; Phase 1

Conditions: Acute Myocardial Infarction; Left Ventricular Dysfunction

Treatments: Biological: UC-MSC; Biological: Control Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03902067

ShanghaiLST-ucmsc-ami01

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

UC-MSC

Experimental group

Description:

UC-MSC transplantation

Treatment:

Biological: UC-MSC

Control Group

Placebo Comparator group

Description:

Routine treatment

Treatment:

Biological: Control Group