Clinical trial NCT03902067: UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
Official title: Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Left Ventricular Dysfunction
Acute Myocardial Infarction
Keywords: AMI
Lead sponsor: Shanghai Life Science & Technology
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
First posted: 2019-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Safety measured as the number of Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Chengxing Shen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: