Clinical trial NCT01392105: Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Mesenchymal stem cells
Myocardial infarction
Left ventricular dysfunction
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: FCB-Pharmicell Co Ltd.
First posted: 2011-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Absolute changes in global LVEF by SPECT
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Changes in left ventricular end-diastolic volume (LVEDV)
timeFrame: baseline and 6 months
measure: Changes in left ventricular end-systolic volume (LVESV)
timeFrame: baseline and 6 months
measure: Changes in regional wall motion score index (WMSI) by Echocardiography
timeFrame: baseline and 6 months
measure: Major adverse cardiac event (MACE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine, Wonju Christian Hospital
state: Gangwon-do
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Yonsei University Wonju College of Medicine, Wonju Christian Hospital
name: Seung-Hwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.