UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
NCT ID: NCT03902067
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-12-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UC-MSC
UC-MSC transplantation
UC-MSC
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.
Control Group
Routine treatment
Control Group
Routine treatment without catheter infusion
Interventions
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UC-MSC
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.
Control Group
Routine treatment without catheter infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Shanghai Life Science & Technology
INDUSTRY
Responsible Party
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Principal Investigators
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Chengxing Shen, Dr.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Locations
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ShanghaiLST-ucmsc-ami01
Identifier Type: -
Identifier Source: org_study_id
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