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. (see Contacts and Locations)
Verified January 2015 by Pharmicell Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01652209
First received: July 25, 2012
Last updated: January 30, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Biological: Hearticellgram-AMI
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Pharmicell Co., Ltd.:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 135
Study Start Date: October 2013
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Hearticellgram-AMI
Other Names:
  • Hearticellgram-AMI
  • (Autologous bone marrow derived mesenchymal stem cells)
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.
Biological: Hearticellgram-AMI
Other Names:
  • Hearticellgram-AMI
  • (Autologous bone marrow derived mesenchymal stem cells)

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652209

Locations
Korea, Republic of
Pharmicell Co., Ltd. Recruiting
Seoul, Korea, Republic of
Contact: Junghee Shin       yunba@pharmicell.com   
Sponsors and Collaborators
Pharmicell Co., Ltd.
Investigators
Principal Investigator: Yang Soo Jang, Ph.D. M.D. Severance Hospital, Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT01652209     History of Changes
Other Study ID Numbers: PMC-BD-CT-P-003
Study First Received: July 25, 2012
Last Updated: January 30, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2015