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

Acute Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392105
• Other study ID #: MSC2-Version 6.0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 5, 2011
• Last updated: July 11, 2011
• Start date: March 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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
• Control group
No additional treatment of mesenchymal stem cells

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine	Seoul
Korea, Republic of	Yonsei University Wonju College of Medicine, Wonju Christian Hospital	Wonju	Gangwon-do

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	FCB-Pharmicell Co Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline and 6 months	No
Secondary	Changes in left ventricular end-diastolic volume (LVEDV)		baseline and 6 months	No
Secondary	Changes in left ventricular end-systolic volume (LVESV)		baseline and 6 months	No
Secondary	Changes in regional wall motion score index (WMSI) by Echocardiography		baseline and 6 months	No
Secondary	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.	6 months	Yes