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

July 11, 2011 updated by: Yonsei University

A Randomized, Open-label, Multicenter Trial for the Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Inchon, Korea, Republic of, 400-711
        • Inha University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
    • Gangwon-do
      • Wonju, Gangwon-do, Korea, Republic of, 220-701
        • Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in left ventricular end-diastolic volume (LVEDV)
Time Frame: baseline and 6 months
baseline and 6 months
Changes in left ventricular end-systolic volume (LVESV)
Time Frame: baseline and 6 months
baseline and 6 months
Changes in regional wall motion score index (WMSI) by Echocardiography
Time Frame: baseline and 6 months
baseline and 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

FCB-Pharmicell Co Ltd.

Investigators

  • Principal Investigator: Seung-Hwan Lee, MD, PhD, Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSC2-Version 6.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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