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

Information source: Pharmicell Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myocardial Infarction

Intervention: Hearticellgram-AMI (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pharmicell Co., Ltd.

Official(s) and/or principal investigator(s):
Yang Soo Jang, Ph.D. M.D., Principal Investigator, Affiliation: Severance Hospital, Yonsei University College of Medicine

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 to a two dose regimen of hearticellgram-AMI.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: LVEF by MRI

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, group 3= two dose of hearticellgram-AMI). single dose of hearticellgram-AMI have been attained new drug approval from MFDS (related to NCT01392105).

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Between the ages of 20-70 2. Left Ventricular Ejection Fraction (LVEF) under 45% 3. Acute myocardial infarction patients fulfilling at least one of the given qualities, through the use of an electrocardiogram (12-lead ECG) A. ST-segment elevation 0. 1 mV in two or more limb leads or B. 0. 2 mV elevation in two or more contiguous precordial leads , indicative of AMI 4. Anterior Wall MI 5. Patients who fulfill the above criteria and also have experienced successful reperfusion 6. Patients who can consent to participate in this clinical trial personally, as well as through a legal attorney Exclusion Criteria: 1. Patients who have been diagnosed with malignant blood-related diseases (acute myelocyte leukemia, acute lymphatic leukemia, non-Hodgkin's lymphoma, multiple myeloma), and have not improved 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 who cannot compliance with the protocol. 16. patients with drug abuser within last 1 year. 17. patients with participating other clinical trials with last 1 month. 18. patients who are likely to have tumor in tumor marker test or patients who has diagnosed cancer in national cancer screening project. 19. inappropriate patients to participate in the study by the investigator's opinion.

Locations and Contacts

Pharmicell Co., Ltd., Seoul, Korea, Republic of; Recruiting
Junghee Shin, Email: yunba@pharmicell.com
Additional Information

Starting date: October 2013
Last updated: January 30, 2015

Page last updated: August 23, 2015

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