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To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.

Sponsor
Pharmicell Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT01652209
Collaborator
(none)
90
Enrollment
10
Locations
2
Arms
124
Anticipated Duration (Months)
9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Hearticellgram-AMI
 Phase 3

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
Actual Study Start Date :
Sep 1, 2013
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

After implementing PCI, contemporary drug treatment is conducted. *Contemporary drug treatment is a general drug treatment (Unfractionated heparin, Low Molecular Weight Heparin, Glycoprotein llb/llla inhibitor, Aspirin, clopidogrel or Ticlopidine, Nitrate, ACE inhibitor or ARB, β-blocker, CCB, Diuretics, Statin, etc.)
Experimental: Single dose of Hearticellgram-AMI

Within 30 days (+ / -7 days) after aspirating bone-marrow, approximately 1×10^6/kg (refer to usage/dosage according to mass) of autologous bone marrow-derived mesenchymal stem cells are adminstered into the infarct coronary artery using balloon tipped catheter. Furthermore, contemporary drug treatment is conducted.

Biological: Hearticellgram-AMI
Other Names:
  • (Autologous bone marrow derived mesenchymal stem cells)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. LVEF amount of change [13 months after the cell treatment]

      Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)

    Secondary Outcome Measures

    1. LVEF amount of change [6 months after the cell treatment]

      Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)

    2. Infarct size amount of change [6, 13 months after the cell treatment]

      Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration

    3. Left ventricle end systolic size change [6, 13 months after the cell treatment]

      Change in left ventricular end systolic size evaluated by MRI at 6 months and 13 months compared to before administration

    4. Left ventricular end-diastolic size change [6, 13 months after the cell treatment]

      Change in left ventricular end diastolic size evaluated by MRI at 6 months and 13 months compared to before administration

    5. Incidence of critical heart events [Within 24 months after the cell treatment]

      The incidence of major cardiac events (death, hospitalization for cardiac shock or heart failure, recurrence of myocardial infarction, occurrence of severe arrhythmias) within 24 months after administration

    6. Heart rate variability change amount [13 months after the cell treatment]

      Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)

    7. Left ventricular local wall movement disorder index change [6, 13 months after the cell treatment]

      The amount of change in the left ventricular local wall movement impairment index evaluated by echocardiography at 6 and 13 months compared to before administration

    8. N-terminal pro-brain natriuretic peptide (NT-proBNP) change [6, 13 months after the cell treatment]

      Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6 and 13 months compared to before administration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    1. Those identified as anterior wall MI

    2. Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain

    3. Who can conduct clinical trials according to the clinical trial protocol

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kangwon National University Hospital Chuncheon Korea, Republic of
    2 Chungnam National University Hospital Chungnam Korea, Republic of
    3 Chonnam National University Hospital Gwangju Korea, Republic of
    4 Yongin Severance Hospital Gyeonggi-do Korea, Republic of
    5 Gachon University Gil Medical Center Incheon Korea, Republic of
    6 Inha University Hospital Incheon Korea, Republic of
    7 Catholic University of Korea, Seoul ST. Mary's Hospital. Seoul Korea, Republic of
    8 Korea University Medicine Seoul Korea, Republic of
    9 Severance Hospital, Yonsei University College of Medicine Seoul Korea, Republic of
    10 Wonju Severance Christian Hospital Wŏnju Korea, Republic of

    Sponsors and Collaborators

    • Pharmicell Co., Ltd.

    Investigators

    • Principal Investigator: Jeonghan Yoon, Ph.D. M.D., Wonju Severance Christian Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pharmicell Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01652209
    Other Study ID Numbers:
    • PMC-BD-CT-P-003
    First Posted:
    Jul 27, 2012
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Oct 22, 2021