Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01167751

Enrollment

Registered

2010-07-22

Start date

2008-01-31

Completion date

2012-07-31

Last updated

2016-06-21

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 cells, AC133

Brief summary

One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure. One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function. The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.

Interventions

BIOLOGICALMNC

Implantation of BM derived MNC

BIOLOGICALAC 133

Implantation of BM derived AC133

BIOLOGICALControl

Injection of cell carrier

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

* CABG candidate * At least 4 akinetic segments * First anterior heart attack within in 10 days to 3 month. * St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography. * The target lesion had to be located in the left anterior descending (LAD) section.

Exclusion criteria

* History of prior anterior myocardial infarction: * History of prior CABG * Poor echocardiography window. * Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l * Documental terminal illness or malignancy. * Previous bone marrow transplant * Autoimmune disease (e. g Lupus, Multiple sclerosis) * Any contraindication for bone - marrow aspiration. * Positive pregnancy test (in women with child bearing potential)

Design outcomes

Primary

Measure	Time frame
Left ventricular ejection fraction at rest, measured by gated SPECT	6 months

Secondary

Measure	Time frame
Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiography	6 months
changes in LVM index, LVEDV, LVESV	6 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026