Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01187654
First received: August 18, 2010
Last updated: December 25, 2012
Last verified: August 2010

August 18, 2010
December 25, 2012
May 2009
September 2012   (final data collection date for primary outcome measure)
Increase from baseline in ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01187654 on ClinicalTrials.gov Archive Site
  • Decrease LVESV/LVEDV/LVM index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    left ventricular end systolic volume (LVESV) left ventricular end diastolic volume (LVEDV) Left Ventricular mass (LVM)
  • Decrease the number of Non Viable segments from baseline [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure

Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure.

This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending (LAD) involvement.

Patient from both gender, who had acute MI within recent 3 Weeks in LAD territory and would underwent PCI are eligible for this study. The bone marrow derived AC 133+ and MNC would be intracoronary injected to the patients during PCI procedure. The control group would be received just serum during PCI. The patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan.

The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Biological: AC133
    intra coronary injection of bone marrow derived AC133+ cells
    Other Name: AC133 injection
  • Biological: MNC
    intra coronary injection of bone marrow derived MNC
    Other Name: MNC injection
  • Biological: CONTROL
    autologous serum injection
    Other Name: placebo injection
  • Experimental: AC133 recipients
    intra coronary injection of bone marrow derived AC133+ cells
    Intervention: Biological: AC133
  • Experimental: MNC recipients
    intra coronary injection of bone marrow derived MNC
    Intervention: Biological: MNC
  • Active Comparator: control
    injection of autologous serum
    Intervention: Biological: CONTROL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI> 30
  • First acute MI in LAD territory
  • St elevation MI
  • Ejection fraction: 20-45%
  • at least two non - mobile or less mobile segment of left ventricular myocard.
  • Successful PCI with stenting

Exclusion Criteria:

  • Multivessel ceremony artery disease
  • Pulmonary edema
  • SBP < 80 mmHg
  • Thrombocytopenia (PLT < 50, 000)
  • INR > 2
  • Hepatic failure or dysfunction
  • Renal failure or dysfunction
  • Positive HIV Ab/ HBC Ab/ HCV Ab/ HSV Ag
  • Documental terminal illness
  • Documental Malignancy
  • Patient with sever coronary disease and unstability of vital sign
  • History of leukopenia, Anemia, hepatic or renal dysfunction or malignancy
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01187654
Royan-Heart-002
Yes
Royan Institute
Royan Institute
Not Provided
Study Chair: Hamid Gourabi, PhD Royan Institute
Principal Investigator: Masoud Ghassemi, MD Royan Institute
Study Director: Nasser Aghdami, PhD,MD Royan Institute
Principal Investigator: Davood Kazemi saleh, MD Royan Institute
Principal Investigator: Hossein Baharvand, PhD Royan Institute
Royan Institute
August 2010

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