RELIEF(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 to a two dose regimen of hearticellgram-AMI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-center, Open-label, Comparison and a Parallel Group Study (3 Groups) Phase 3 Clinical Trial for a Comparative Evaluation With the Existing Treatments, in Order to Verify the Long-term Efficacy and Safety of the First Cell Treatment Using Hearticellgram-AMI(Autologous Human Bone Marrow Derived Mesenchymal Stem Cells) in AMI Patients, and to Observe the Efficacy of the Second Cell Treatment.|
- LVEF by MRI [ Time Frame: 13 months after the cell treatment ] [ Designated as safety issue: No ]Left ventricle ejection fraction (LVEF) measured 13 months after the cell treatment (MRI measurement)
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
Experimental: Two doses 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. After 30 days (+ / -7 days) from the first injection, a two dose of hearticellgram-AMI is administered in the same way. Furthermore, temporary drug treatment is conducted.
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, group 3= two dose of hearticellgram-AMI). single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652209
|Korea, Republic of|
|Pharmicell Co., Ltd.||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Junghee Shin email@example.com|
|Principal Investigator:||Yang Soo Jang, Ph.D. M.D.||Severance Hospital, Yonsei University College of Medicine|