Clinical trial NCT01652209: To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.
Official title: A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute Myocardial Infarction
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Through the injection of Hearticellgram-AMI into acute myocardial infarction patients who are the primary targets of the drug, long term efficacy in the improvement of the left ventricle ejection fraction upon the first cell treatment is to be evaluated and compared with the current existing treatments (contemporary drug treatment).

This study will also compare the efficacy and safety of single dose of hearticellgram-AMI.

Detailed description: We are enrolling a patient who had successful conventional percutaneous coronary intervention after acute myocardial infarction. Patients are allocated to one of three groups (group1=comparator, group2= one dose of hearticellgram-AMI).

single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).

Eligibility criteria: Inclusion Criteria:

1. As of the date of written consent, between 20 and 75 years of age
2. Those with less than 50% of the left ventricular ejection fraction (LVEF) on echocardiography performed after percutaneous coronary intervention (PCI) (evaluated by investigator)
3. Who has been identified as an acute myocardial infarction in any of the following on an electrocardiogram (12-lead electrocardiography, ECG) performed before PCI

   * ST-segment elevation 0.1 mV in two or more limb leads or
   * 0.2 mV elevation in two or more contiguous precordial leads indicative of acute myocardial infarction (AMI)
4. Those identified as anterior wall MI
5. Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain
6. Who can conduct clinical trials according to the clinical trial protocol
7. Who has consented in writing to voluntarily participate in this clinical trial (owner or legal representative)

Exclusion Criteria:

1. Who have not been diagnosed with malignant blood diseases (acute myelogenous leukemia, acute lymphocytic leukemia, non-Hodgkins lymphoma, Hodgkins lymphoma, multiple myelopathy) within 5 years of screening criteria
2. Patients with severe aplastic anemia
3. Patients with solid cancers in their previous medical history (within 5 years)
4. Patients whose blood serum AST/ASL rates are more than three times the normal maximum rate, and whose creatinine rates are more than 1.5 times the normal maximum rate (but AST in myocardial infarction patients can temporarily rise, thus, as decided by the researchers, if there is no damage to the liver function, the rise will not be taken into consideration)
5. Patients who have implemented Coronary Artery Bypass Graft(CABG)
6. Patients with chronic heart failure (patients with medical history of heart failure medical history at least three months before the occurrence of acute myocardial infarction)
7. Patients who cannot proceed with cardiac catheterization
8. Patients who had been continuously taking large doses of steroids (1mg/kg/day) or antibiotics for severe infections from one month prior to registration
9. Patients who had major surgical operations, organ biopsy, or significant external injury as determined by the researcher, within three months before registration
10. Patients who have head injuries or other external injuries after the development of myocardial infarction
11. patients with stroke or transient ischemic attack within six months before registration, patients with history of central nervous system disease (tumor, aneurysm, brain surgery etc.)
12. Patients with low survival ability after cardiopulmonary resuscitation within last 2 weeks.
13. Patients with positive for HIV, HBV, HCV, Syphilis
14. pregnant women or likely to be pregnant or lactating women
15. Patients with drug abuser within last 1 year.
16. Patients with participating other clinical trials with last 1 month.
17. When the possibility of tumor occurrence is seen when the tester judges even one of the tumor marker tests during screening
18. Who are judged to be inappropriate to participate in this test when judged by the examiner

Primary outcomes:
measure: LVEF amount of change
timeFrame: 13 months after the cell treatment
Secondary outcomes:
measure: LVEF amount of change
timeFrame: 6 months after the cell treatment
measure: Infarct size amount of change
timeFrame: 6, 13 months after the cell treatment
measure: Left ventricle end systolic size change
timeFrame: 6, 13 months after the cell treatment
measure: Left ventricular end-diastolic size change
timeFrame: 6, 13 months after the cell treatment
measure: Incidence of critical heart events
timeFrame: Within 24 months after the cell treatment
measure: Heart rate variability change amount
timeFrame: 13 months after the cell treatment
measure: Left ventricular local wall movement disorder index change
timeFrame: 6, 13 months after the cell treatment
measure: N-terminal pro-brain natriuretic peptide (NT-proBNP) change
timeFrame: 6, 13 months after the cell treatment
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Chungnam
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Yongin Severance Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea, Seoul ST. Mary's Hospital.
city: Seoul
country: Korea, Republic of
facility: Korea University Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Jeonghan Yoon, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References: