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

NCT ID: NCT01187654

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

Conditions

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Myocardial Infarction

Keywords

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myocardial infarction bone marrow stem cell AC133 mono nuclear cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AC133 recipients

intra coronary injection of bone marrow derived AC133+ cells

Group Type EXPERIMENTAL

AC133

Intervention Type BIOLOGICAL

intra coronary injection of bone marrow derived AC133+ cells

MNC recipients

intra coronary injection of bone marrow derived MNC

Group Type EXPERIMENTAL

MNC

Intervention Type BIOLOGICAL

intra coronary injection of bone marrow derived MNC

control

injection of autologous serum

Group Type ACTIVE_COMPARATOR

CONTROL

Intervention Type BIOLOGICAL

autologous serum injection

Interventions

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AC133

intra coronary injection of bone marrow derived AC133+ cells

Intervention Type BIOLOGICAL

MNC

intra coronary injection of bone marrow derived MNC

Intervention Type BIOLOGICAL

CONTROL

autologous serum injection

Intervention Type BIOLOGICAL

Other Intervention Names

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AC133 injection MNC injection placebo injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Royan Institute

Masoud Ghassemi, MD

Role: PRINCIPAL_INVESTIGATOR

Royan Institute

Nasser Aghdami, PhD,MD

Role: STUDY_DIRECTOR

Royan Institute

Davood Kazemi saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Royan Institute

Hossein Baharvand, PhD

Role: PRINCIPAL_INVESTIGATOR

Royan Institute

Locations

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Royan institute

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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Royan-Heart-002

Identifier Type: -

Identifier Source: org_study_id