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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mesenchymal stem cell
Control group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Mesenchymal stem cells, Myocardial infarction, Left ventricular dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University Wonju College of Medicine, Wonju Christian Hospital
  • Inha University Hospital
  • Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mesenchymal stem cell treatment group

Control group

Arm Description

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)

Outcomes

Primary Outcome Measures

Absolute changes in global LVEF by SPECT
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)
Changes in left ventricular end-systolic volume (LVESV)
Changes in regional wall motion score index (WMSI) by Echocardiography
Major adverse cardiac event (MACE)
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.

Full Information

First Posted
July 5, 2011
Last Updated
July 11, 2011
Sponsor
Yonsei University
Collaborators
FCB-Pharmicell Co Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01392105
Brief Title
Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction
Acronym
SEED-MSC
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University
Collaborators
FCB-Pharmicell Co Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Mesenchymal stem cells, Myocardial infarction, Left ventricular dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell treatment group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Mesenchymal stem cell
Other Intervention Name(s)
Hearticellgram-AMI
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Control group
Intervention Description
No additional treatment of mesenchymal stem cells
Primary Outcome Measure Information:
Title
Absolute changes in global LVEF by SPECT
Description
Absolute changes in global left ventricular ejection fraction (LVEF) as measured by SPECT 6 months after cell infusion
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Changes in left ventricular end-diastolic volume (LVEDV)
Time Frame
baseline and 6 months
Title
Changes in left ventricular end-systolic volume (LVESV)
Time Frame
baseline and 6 months
Title
Changes in regional wall motion score index (WMSI) by Echocardiography
Time Frame
baseline and 6 months
Title
Major adverse cardiac event (MACE)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Hwan Lee, MD, PhD
Organizational Affiliation
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inchon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24431901
Citation
Lee JW, Lee SH, Youn YJ, Ahn MS, Kim JY, Yoo BS, Yoon J, Kwon W, Hong IS, Lee K, Kwan J, Park KS, Choi D, Jang YS, Hong MK. A randomized, open-label, multicenter trial for the safety and efficacy of adult mesenchymal stem cells after acute myocardial infarction. J Korean Med Sci. 2014 Jan;29(1):23-31. doi: 10.3346/jkms.2014.29.1.23. Epub 2013 Dec 26.
Results Reference
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Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction

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