Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction

NCT ID: NCT01392105

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-05-31

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mesenchymal stem cell treatment group

Group Type: ACTIVE_COMPARATOR

Mesenchymal stem cell

Intervention Type: 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

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)

Group Type: PLACEBO_COMPARATOR

Control group

Intervention Type: DRUG

No additional treatment of mesenchymal stem cells

Interventions

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

Intervention Type: DRUG

Control group

No additional treatment of mesenchymal stem cells

Intervention Type: DRUG

Other Intervention Names

Hearticellgram-AMI

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FCB-Pharmicell Co Ltd.

UNKNOWN

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Principal Investigators

Seung-Hwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Locations

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Wŏnju, Gangwon-do, South Korea

Inha University Hospital

Inchon, , South Korea

Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24431901 (View on PubMed)

Other Identifiers

MSC2-Version 6.0

Identifier Type: -

Identifier Source: org_study_id