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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01187654

Enrollment

Registered

2010-08-24

Start date

2009-05-31

Completion date

2012-12-31

Last updated

2012-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, bone marrow stem cell, AC133, mono nuclear cell

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

Interventions

BIOLOGICALAC133

intra coronary injection of bone marrow derived AC133+ cells

BIOLOGICALMNC

intra coronary injection of bone marrow derived MNC

BIOLOGICALCONTROL

autologous serum injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Increase from baseline in ejection fraction	6 months

Secondary

Measure	Time frame	Description
Decrease LVESV/LVEDV/LVM index	6 months	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	6 months	—

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026