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

NCT01652209 | Completed Phase 3 DMC

• 1 other identifier: PMC-BD-CT-P-003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 10

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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• LVEF amount of change

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

  13 months after the cell treatment

Secondary Outcomes (8)

• LVEF amount of change

  6 months after the cell treatment

• Infarct size amount of change

  6, 13 months after the cell treatment

• Left ventricle end systolic size change

  6, 13 months after the cell treatment

• Left ventricular end-diastolic size change

  6, 13 months after the cell treatment

• Incidence of critical heart events

  Within 24 months after the cell treatment

Study Arms (2)

Control

NO INTERVENTION

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.)

Single dose of Hearticellgram-AMI

EXPERIMENTAL

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

Interventions

Hearticellgram-AMI BIOLOGICAL

Also known as: (Autologous bone marrow derived mesenchymal stem cells)

Single dose of Hearticellgram-AMI

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• As of the date of written consent, between 20 and 75 years of age
• Those with less than 50% of the left ventricular ejection fraction (LVEF) on echocardiography performed after percutaneous coronary intervention (PCI) (evaluated by investigator)
• 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
• mV elevation in two or more contiguous precordial leads indicative of acute myocardial infarction (AMI)
• Those identified as anterior wall MI
• Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain
• Who can conduct clinical trials according to the clinical trial protocol
• Who has consented in writing to voluntarily participate in this clinical trial (owner or legal representative)

You may not qualify if:

• 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
• Patients with severe aplastic anemia
• Patients with solid cancers in their previous medical history (within 5 years)
• 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)
• Patients who have implemented Coronary Artery Bypass Graft(CABG)
• 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)
• Patients who cannot proceed with cardiac catheterization
• Patients who had been continuously taking large doses of steroids (1mg/kg/day) or antibiotics for severe infections from one month prior to registration
• Patients who had major surgical operations, organ biopsy, or significant external injury as determined by the researcher, within three months before registration
• Patients who have head injuries or other external injuries after the development of myocardial infarction
• 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.)
• Patients with low survival ability after cardiopulmonary resuscitation within last 2 weeks.
• Patients with positive for HIV, HBV, HCV, Syphilis
• pregnant women or likely to be pregnant or lactating women
• Patients with drug abuser within last 1 year.

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (10)

Kangwon National University Hospital

Chuncheon, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Yongin Severance Hospital

Gyeonggi-do, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Chungnam National University Hospital

Jungnam, South Korea

Location

Catholic University of Korea, Seoul ST. Mary's Hospital.

Seoul, South Korea

Location

Korea University Medicine

Seoul, South Korea

Location

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Study Officials

• Jeonghan Yoon, Ph.D. M.D.

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: September 1, 2013
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

KR (10)