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Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction (SEED-MSC)

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. Read our disclaimer for details. Identifier: NCT01392105
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 12, 2011
FCB-Pharmicell Co Ltd.
Information provided by:
Yonsei University

Brief Summary:
Early reperfusion strategies in tandem with remarkable advances in drugs and devices for treating myocardial infarction (MI) have contributed to a reduction in early mortality, but cardiovascular disease remains the leading cause of death worldwide. Current management strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart failure. In this respect, stem-cell therapy has shown potential benefits for repairing the damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive therapeutic candidates because of their high capacity for replication: paracrine effect: ability to preserve potency: and because they do not cause adverse reactions to allogeneic versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but only one clinical trial using MSCs via the intracoronary route in the setting of acute myocardial infarction (AMI) has been carried out. The investigators therefore assessed the safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in patients with AMI.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Mesenchymal stem cell Drug: Control group Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multicenter Trial for the Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction
Study Start Date : March 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Mesenchymal stem cell treatment group Drug: Mesenchymal stem cell
Route : intracoronary injection Frequency : single dose of autologous bone-marrow derived mesenchymal stem cells Dosage : 1x1000000 cells/kg Duration : mean injection duration approximately 4 weeks after primary percutaneous coronary intervention
Other Name: Hearticellgram-AMI

Placebo Comparator: Control group
All patients were required to have successful revascularization of an infarct-related artery on coronary angiography at the time of randomization. All patients received aspirin (300 mg loading dose, then 100 mg daily) and clopidogrel (600 mg loading dose, then 75 mg daily) with optimal medical therapy according to the American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines for treatment of ST-segment elevation myocardial infarction (STEMI)
Drug: Control group
No additional treatment of mesenchymal stem cells

Primary Outcome Measures :
  1. Absolute changes in global LVEF by SPECT [ Time Frame: baseline and 6 months ]
    Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion

Secondary Outcome Measures :
  1. Changes in left ventricular end-diastolic volume (LVEDV) [ Time Frame: baseline and 6 months ]
  2. Changes in left ventricular end-systolic volume (LVESV) [ Time Frame: baseline and 6 months ]
  3. Changes in regional wall motion score index (WMSI) by Echocardiography [ Time Frame: baseline and 6 months ]
  4. Major adverse cardiac event (MACE) [ Time Frame: 6 months ]
    MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 18-70 years
  • ischemic chest pain for >30 min
  • admitted to hospital <24 h after the onset of chest pain
  • electrocardiography showed ST segment elevation >1 mm in two consecutive leads in the limb leads or >2 mm in the precordial leads
  • they could be enrolled in the study <72 h after successful revascularization

Exclusion Criteria:

  • cardiogenic shock (defined as systolic blood pressure <90 mmHg requiring intravenous pressors or intra-aortic balloon counterpulsation)
  • life-threatening arrhythmia
  • impossible conditions for cardiac catheterization
  • advanced renal or hepatic dysfunction
  • history of previous coronary artery bypass graft
  • history of hematologic disease
  • history of malignancy
  • major bleeding requiring blood transfusion
  • stroke or transient ischemic attack in the previous 6 months
  • structural abnormalities of the central nervous system (brain tumor, aneurysm, history of surgery)
  • traumatic injury after myocardial infarction
  • use of corticosteroids or antibiotics during the previous month
  • major surgical procedure in the previous 3 months
  • cardiopulmonary resuscitation for >10 min within the previous 2 weeks
  • positive skin test for penicillin
  • positive result for viral markers (human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and Venereal Disease Research Laboratory (VDRL) test)
  • pregnancy, possible candidate for pregnancy or breastfeeding females
  • drug abusers
  • inappropriate patients to participate in the study according to the chief investigator

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 identifier (NCT number): NCT01392105

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Korea, Republic of
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Wonju, Gangwon-do, Korea, Republic of, 220-701
Inha University Hospital
Inchon, Korea, Republic of, 400-711
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
FCB-Pharmicell Co Ltd.
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Principal Investigator: Seung-Hwan Lee, MD, PhD Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Seung-Hwan Lee/Professor, Yonsei University Wonju College of Medicine, Wonju Christian Hospital Identifier: NCT01392105     History of Changes
Other Study ID Numbers: MSC2-Version 6.0
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2009

Keywords provided by Yonsei University:
Mesenchymal stem cells
Myocardial infarction
Left ventricular dysfunction

Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases