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

This study has been completed.
Sponsor:
Collaborator:
FCB-Pharmicell Co Ltd.
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01392105
First received: July 5, 2011
Last updated: July 11, 2011
Last verified: July 2009
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Drug: Mesenchymal stem cell
Drug: Control group
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Absolute changes in global LVEF by SPECT [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion


Secondary Outcome Measures:
  • Changes in left ventricular end-diastolic volume (LVEDV) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in left ventricular end-systolic volume (LVESV) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Changes in regional wall motion score index (WMSI) by Echocardiography [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Major adverse cardiac event (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 80
Study Start Date: March 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Control group

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392105

Locations
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.
Investigators
Principal Investigator: Seung-Hwan Lee, MD, PhD Yonsei University Wonju College of Medicine, Wonju Christian Hospital
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Hwan Lee/Professor, Yonsei University Wonju College of Medicine, Wonju Christian Hospital
ClinicalTrials.gov Identifier: NCT01392105     History of Changes
Other Study ID Numbers: MSC2-Version 6.0
Study First Received: July 5, 2011
Last Updated: July 11, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

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

ClinicalTrials.gov processed this record on April 21, 2014