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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
 Biological: AC133
Biological: MNC
Biological: CONTROL
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Increase from baseline in ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: May 2009
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC133 recipients
intra coronary injection of bone marrow derived AC133+ cells
 Biological: AC133
intra coronary injection of bone marrow derived AC133+ cells
Other Name: AC133 injection
Experimental: MNC recipients
intra coronary injection of bone marrow derived MNC
 Biological: MNC
intra coronary injection of bone marrow derived MNC
Other Name: MNC injection
Active Comparator: control
injection of autologous serum
 Biological: CONTROL
autologous serum injection
Other Name: placebo injection

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187654

Locations
Iran, Islamic Republic of
Royan institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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
  More Information

No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01187654     History of Changes
Other Study ID Numbers: Royan-Heart-002
Study First Received: August 18, 2010
Last Updated: December 25, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
myocardial infarction
bone marrow stem cell
AC133
mono nuclear cell

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

ClinicalTrials.gov processed this record on May 19, 2013