Hearticellgram-AMI
BiologicalOther names: (Autologous bone marrow derived mesenchymal stem cells)
NCT Number: NCT01652209
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.
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Notify Me20 year–75 year
All sexes
Interventional
Phase 3
Kangwon National University Hospital, Chuncheon, South Korea
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: (Autologous bone marrow derived mesenchymal stem cells)
Time frame: 13 months after the cell treatment
Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)
Time frame: 6 months after the cell treatment
Left ventricle ejection fraction (LVEF) measured 6 months after the cell treatment (MRI measurement)
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
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
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
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
Time frame: 13 months after the cell treatment
Heart rate variability change at 13 months compared to before administration (24 hours Holter measurement)
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
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
Pharmicell Co., Ltd.
Industry
A Randomized,Open labEled, muLticenter Trial for Safety and Efficacy of Intracoronary Adult Human Mesenchymal stEm Cells Acute Myocardial inFarction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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