Acute Myocardial InfarctionPhase 3NCT01652209
To Evaluate the Efficacy and Safety of Hearticelgram®-AMI in Patients With Acute Myocardial Infarction.
A Phase 3 study testing Hearticellgram-AMI in people with Acute Myocardial Infarction, run by Pharmicell Co., Ltd. at 10 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Hearticellgram-AMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 1 Sep 2013to 12 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 0.2 mV elevation in two or more contiguous precordial leads indicative of acute myocardial infarction (AMI)
- Those identified as anterior wall MI
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- 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)
Who cannot join
- 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)
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- 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.
- Patients with participating other clinical trials with last 1 month.
- When the possibility of tumor occurrence is seen when the tester judges even one of the tumor marker tests during screening
- Who are judged to be inappropriate to participate in this test when judged by the examiner
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Kangwon National University Hospital
Chuncheon
Chonnam National University Hospital
Gwangju
Yongin Severance Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Inha University Hospital
Incheon
Chungnam National University Hospital
Jungnam
Catholic University of Korea, Seoul ST. Mary's Hospital.
Seoul
Korea University Medicine
Seoul
Severance Hospital, Yonsei University College of Medicine
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
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.
Read the 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).
- Conditions
- Acute Myocardial Infarction
- Being tested
- Hearticellgram-AMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearticellgram-AMIBiological
Also called (Autologous bone marrow derived mesenchymal stem cells)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Hearticellgram-AMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF amount of change
Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)
Measured: 13 months after the cell treatment
Secondary outcomes (8)
LVEF amount of change
Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)
Measured: 6 months after the cell treatment
Infarct size amount of change
Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration
Measured: 6, 13 months after the cell treatment
Left ventricle end systolic size change
Change in left ventricular end systolic size evaluated by MRI at 6 months and 13 months compared to before administration
Measured: 6, 13 months after the cell treatment
Left ventricular end-diastolic size change
Change in left ventricular end diastolic size evaluated by MRI at 6 months and 13 months compared to before administration
Measured: 6, 13 months after the cell treatment
Incidence of critical heart events
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
Measured: Within 24 months after the cell treatment
Heart rate variability change amount
Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)
Measured: 13 months after the cell treatment
Left ventricular local wall movement disorder index change
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
Measured: 6, 13 months after the cell treatment
N-terminal pro-brain natriuretic peptide (NT-proBNP) change
Changes in N-terminal pro-brain natriuretic peptide (NT-proBNP) at 6 and 13 months compared to before administration
Measured: 6, 13 months after the cell treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study start1 Sep 2013
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeonghan Yoon, Ph.D. M.D., Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652209
- Sponsor's protocol ID
- PMC-BD-CT-P-003
- Status last verified
- Feb 2026
- First submitted
- 25 Jul 2012
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
- ClinicalTrials.gov ID
- NCT01652209
- Acronym / sponsor ID
- PMC-BD-CT-P-003
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Hearticellgram-AMIWithin 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Those identified as anterior wall MI
- Who meet the above criteria and have successfully reperfused within 72 hours after the onset of chest pain
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearticellgram-AMIAlso: (Autologous bone marrow derived mesenchymal stem cells) | Biological | Single dose of Hearticellgram-AMI |
Primary outcome
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)
8 secondary outcomes
LVEF amount of change
Time frame: 6 months after the cell treatment
Infarct size amount of change
Time frame: 6, 13 months after the cell treatment
Left ventricle end systolic size change
Time frame: 6, 13 months after the cell treatment
Left ventricular end-diastolic size change
Time frame: 6, 13 months after the cell treatment
Incidence of critical heart events
Time frame: Within 24 months after the cell treatment
Heart rate variability change amount
Time frame: 13 months after the cell treatment
Left ventricular local wall movement disorder index change
Time frame: 6, 13 months after the cell treatment
N-terminal pro-brain natriuretic peptide (NT-proBNP) change
Time frame: 6, 13 months after the cell treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeonghan Yoon, Ph.D. M.D. principal investigator
Wonju Severance Christian Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hearticellgram-AMI in people with Acute Myocardial Infarction, run by Pharmicell Co., Ltd. at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LVEF amount of change (time frame: 13 months after the cell treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.