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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

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT01187654

First Posted

August 18, 2010

Last Updated

December 25, 2012

Sponsor

Royan Institute

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

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: