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

• ClinicalTrials.gov Identifier: NCT01652209
• Recruitment Status: Recruiting
• First Posted: July 27, 2012
• Last Update Posted: October 22, 2021
• Sponsor: Pharmicell Co., Ltd.
• Information provided by (Responsible Party): Pharmicell Co., Ltd.

Tracking Information

• First Submitted Date: July 25, 2012
• First Posted Date: July 27, 2012
• Last Update Posted Date: October 22, 2021
• Actual Study Start Date: September 1, 2013
• Estimated Primary Completion Date: August 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2020)

LVEF amount of change [ Time Frame: 13 months after the cell treatment ]

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

Original Primary Outcome Measures (submitted: July 25, 2012)

LVEF by MRI [ Time Frame: 13 months after the cell treatment ]

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

Current Secondary Outcome Measures (submitted: October 21, 2020)

• LVEF amount of change [ Time Frame: 6 months after the cell treatment ]
  Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)
• Infarct size amount of change [ Time Frame: 6, 13 months after the cell treatment ]
  Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration
• Left ventricle end systolic size change [ Time Frame: 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
• Left ventricular end-diastolic size change [ Time Frame: 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
• Incidence of critical heart events [ Time Frame: 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
• Heart rate variability change amount [ Time Frame: 13 months after the cell treatment ]
  Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)
• Left ventricular local wall movement disorder index change [ Time Frame: 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
• N-terminal pro-brain natriuretic peptide (NT-proBNP) change [ Time Frame: 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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).

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

Biological: Hearticellgram-AMI

Other Name: (Autologous bone marrow derived mesenchymal stem cells)

Study Arms

• 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.
  Intervention: Biological: Hearticellgram-AMI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 21, 2020): 90
• Original Estimated Enrollment (submitted: July 25, 2012): 135
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: August 31, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: JIYEOUN JEONG; 82-2-3496-0134; jyjeong@pharmicell.com

Contact: Jeonghan Yoon, Ph.D. M.D.

• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01652209
• Other Study ID Numbers: PMC-BD-CT-P-003
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pharmicell Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Pharmicell Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pharmicell Co., Ltd.
• Verification Date: October 2021