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UC-MSC Transplantation for Left Ventricular Dysfunction After AMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902067
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Information provided by (Responsible Party):
Shanghai Life Science & Technology

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

Condition or disease Intervention/treatment Phase
Left Ventricular Dysfunction Acute Myocardial Infarction Biological: UC-MSC Biological: Control Group Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Umbilical Cord Mesenchymal Stem Cells Transcatheter Transplantation to Treat Left Ventricular Dysfunction After Acute Myocardial Infarction
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: UC-MSC
UC-MSC transplantation
Biological: 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.
Other Name: Transplantation Group

Placebo Comparator: Control Group
Routine treatment
Biological: Control Group
Routine treatment without catheter infusion




Primary Outcome Measures :
  1. Safety measured as the number of Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]
    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 :
  1. Difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 12 months follow-up [ Time Frame: 12 months ]
    left ventricular ejection fraction measured by magnetic resonance imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902067


Contacts
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Contact: Chengxing Shen +86-18501664545 shencx@sjtu.edu.cn
Contact: Gang LU +862134712825 glu@shlifestemcell.com

Locations
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China, Shanghai
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai, China, 200233
Contact: Chengxing Shen    +86-18501664545    shencx@sjtu.edu.cn   
Sponsors and Collaborators
Shanghai Life Science & Technology
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Investigators
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Principal Investigator: Chengxing Shen, Dr. Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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Responsible Party: Shanghai Life Science & Technology
ClinicalTrials.gov Identifier: NCT03902067    
Other Study ID Numbers: ShanghaiLST-ucmsc-ami01
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Life Science & Technology:
AMI
Additional relevant MeSH terms:
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Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases