Back to resultsUC-MSC Transplantation for Left Ventricular Dysfunction After AMI
Primary Purpose
Left Ventricular Dysfunction, Acute Myocardial Infarction
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UC-MSC
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Left Ventricular Dysfunction focused on measuring AMI
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
Sites / Locations
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
UC-MSC
Control Group
Arm Description
UC-MSC transplantation
Routine treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03902067
First Posted
March 28, 2019
Last Updated
April 10, 2023
Sponsor
Shanghai Life Science & Technology
Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03902067
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Life Science & Technology
Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction, Acute Myocardial Infarction
Keywords
AMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UC-MSC
Arm Type
Experimental
Arm Description
UC-MSC transplantation
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Routine treatment
Intervention Type
Biological
Intervention Name(s)
UC-MSC
Other Intervention Name(s)
Transplantation Group
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Control Group
Intervention Description
Routine treatment without catheter infusion
Primary Outcome Measure Information:
Title
Safety measured as the number of Major Adverse Cardiac Events (MACE)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up
Description
left ventricular ejection fraction measured by magnetic resonance imaging
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengxing Shen
Phone
+86-18501664545
Email
shencx@sjtu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Gang LU
Phone
+862134712825
Email
glu@shlifestemcell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengxing Shen, Dr.
Organizational Affiliation
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengxing Shen
Phone
+86-18501664545
Email
shencx@sjtu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
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