Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
AC133
MNC
CONTROL
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring myocardial infarction, bone marrow stem cell, AC133, mono nuclear cell
Eligibility 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
Sites / Locations
- Royan institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
AC133 recipients
MNC recipients
control
Arm Description
intra coronary injection of bone marrow derived AC133+ cells
intra coronary injection of bone marrow derived MNC
injection of autologous serum
Outcomes
Primary Outcome Measures
Increase from baseline in ejection fraction
Secondary Outcome Measures
Decrease LVESV/LVEDV/LVM index
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01187654
Brief Title
Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, bone marrow stem cell, AC133, mono nuclear cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AC133 recipients
Arm Type
Experimental
Arm Description
intra coronary injection of bone marrow derived AC133+ cells
Arm Title
MNC recipients
Arm Type
Experimental
Arm Description
intra coronary injection of bone marrow derived MNC
Arm Title
control
Arm Type
Active Comparator
Arm Description
injection of autologous serum
Intervention Type
Biological
Intervention Name(s)
AC133
Other Intervention Name(s)
AC133 injection
Intervention Description
intra coronary injection of bone marrow derived AC133+ cells
Intervention Type
Biological
Intervention Name(s)
MNC
Other Intervention Name(s)
MNC injection
Intervention Description
intra coronary injection of bone marrow derived MNC
Intervention Type
Biological
Intervention Name(s)
CONTROL
Other Intervention Name(s)
placebo injection
Intervention Description
autologous serum injection
Primary Outcome Measure Information:
Title
Increase from baseline in ejection fraction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Decrease LVESV/LVEDV/LVM index
Description
left ventricular end systolic volume (LVESV) left ventricular end diastolic volume (LVEDV) Left Ventricular mass (LVM)
Time Frame
6 months
Title
Decrease the number of Non Viable segments from baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Masoud Ghassemi, MD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasser Aghdami, PhD,MD
Organizational Affiliation
Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Davood Kazemi saleh, MD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hossein Baharvand, PhD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
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