UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
May 6, 2026 updated by: Shanghai Life Science & Technology
Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction
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
Study Overview
Status
Withdrawn
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200233
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: UC-MSC
UC-MSC transplantation
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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.
Other Names:
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Placebo Comparator: Control Group
Routine treatment
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Routine treatment without catheter infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety measured as the number of Major Adverse Cardiac Events (MACE)
Time Frame: 12 months
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up
Time Frame: 12 months
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left ventricular ejection fraction measured by magnetic resonance imaging
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12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chengxing Shen, Dr., Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShanghaiLST-ucmsc-ami01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.