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

This study is currently recruiting participants.
Verified November 2013 by Pharmicell Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01652209
First received: July 25, 2012
Last updated: November 13, 2013
Last verified: November 2013

July 25, 2012
November 13, 2013
October 2013
November 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01652209 on ClinicalTrials.gov Archive Site
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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)
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.

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 (temporary drug treatment).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
Biological: Hearticellgram-AMI
Other Names:
  • Hearticellgram-AMI
  • (human bone marrow derived mesenchymal stem cells)
  • No Intervention: Control

    After implementing PCI, temporary drug treatment is conducted.

    *Temporary drug treatment is a general drug treatment (Unfractionated heparin, Low Molecular Weight Heparin, Glycoprotien llb/llla inhibitor, Aspirin, clopidogrel or Ticlopidine, Nitrate, ACE inhibitor or ARB, β-blocker, CCB, Diuretics, Statin, etc.)

  • Experimental: Treatment group 1
    Within four weeks after performing PCI and bone marrow puncture, infarct coronary artery catheter is used to inject approximately 1×10^6/kg (refer to usage/dosage according to mass) of human bone marrow-derived mesenchymal stem cells into the infarct coronary artery. Furthermore, temporary drug treatment is conducted.
    Intervention: Biological: Hearticellgram-AMI
  • Experimental: Treatment group 2

    Within four weeks after performing PCI and bone marrow puncture, infarct coronary artery catheter is used to inject approximately 1×10^6/kg (refer to usage/dosage according to mass) of human bone marrow-derived mesenchymal stem cells into the infarct coronary artery. Furthermore, temporary drug treatment is conducted.

    However, among the human bone marrow-derived mesenchymal stem cell cultures obtained after bone marrow collection, the first batch of the stem cell cultures is stored, and after the first cell injection, the second cell injection is conducted within a month.

    Intervention: Biological: Hearticellgram-AMI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
135
Not Provided
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Between the ages of 20-70
  2. Left Ventricular Ejection Fraction (LVEF) under 45%
  3. Acute myocardial infraction 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 major 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 (CAB)
  6. Patients with chronic heart failure (patients with 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 or antibiotics 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
Both
20 Years to 70 Years
No
Not Provided
Korea, Republic of
 
NCT01652209
PMC-BD-CT-P-003
No
Pharmicell Co., Ltd.
Pharmicell Co., Ltd.
Not Provided
Principal Investigator: Yang Soo Jang, Ph.D. M.D. Severance Hospital, Yonsei University College of Medicine
Pharmicell Co., Ltd.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP