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

Acute Myocardial Infarction Clinical Trial

Official title:

A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01652209
• Other study ID #: PMC-BD-CT-P-003
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 1, 2013
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 drug treatment).

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Biological:
• Hearticellgram-AMI

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Chungnam
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Yongin Severance Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Catholic University of Korea, Seoul ST. Mary's Hospital.	Seoul
Korea, Republic of	Korea University Medicine	Seoul
Korea, Republic of	Severance Hospital, Yonsei University College of Medicine	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	LVEF amount of change	Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)	6 months after the cell treatment
Secondary	Infarct size amount of change	Change in infarct size evaluated by MRI at 6 and 13 months compared to before administration	6, 13 months after the cell treatment
Secondary	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	6, 13 months after the cell treatment
Secondary	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	6, 13 months after the cell treatment
Secondary	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	Within 24 months after the cell treatment
Secondary	Heart rate variability change amount	Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)	13 months after the cell treatment
Secondary	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	6, 13 months after the cell treatment
Secondary	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	6, 13 months after the cell treatment