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NCT Number: NCT01392105

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.

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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Yonsei University Wonju College of Medicine, Wonju Christian Hospital, Wŏnju, Gangwon-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesenchymal stem cell

Drug

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

Control group

Drug

No additional treatment of mesenchymal stem cells

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • FCB-Pharmicell Co Ltd.

Registry information

Official study title

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

Acronym: SEED-MSC

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 12, 2011
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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