NCT01392105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2007

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

July 12, 2011

Status Verified

July 1, 2009

Enrollment Period

3.2 years

First QC Date

July 5, 2011

Last Update Submit

July 11, 2011

Conditions

Acute Myocardial Infarction

Keywords

Mesenchymal stem cellsMyocardial infarctionLeft ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Changes in left ventricular end-diastolic volume (LVEDV)

    baseline and 6 months

  • Changes in left ventricular end-systolic volume (LVESV)

    baseline and 6 months

  • Changes in regional wall motion score index (WMSI) by Echocardiography

    baseline and 6 months

  • Major adverse cardiac event (MACE)

    6 months

Study Arms (2)

Mesenchymal stem cell treatment group

ACTIVE COMPARATOR
Drug: Mesenchymal stem cell

Control group

PLACEBO COMPARATOR

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

Interventions

Mesenchymal stem cellDRUG

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

Also known as: Hearticellgram-AMI
Mesenchymal stem cell treatment group
Control groupDRUG

No additional treatment of mesenchymal stem cells

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Inha University Hospital

Inchon, 400-711, South Korea

Location

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

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24431901DERIVED

MeSH Terms

Conditions

Myocardial InfarctionVentricular Dysfunction, Left

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisVentricular Dysfunction

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Seung-Hwan Lee, MD, PhD

    Yonsei University Wonju College of Medicine, Wonju Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 12, 2011

Study Start

March 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 12, 2011

Record last verified: 2009-07

Locations

KR(3)