Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

Phase 3

Completed

• Conditions: Myocardial Infarction

• Registration Number: NCT01167751
• Lead Sponsor: Royan Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Last Update Submitted: 2016-06-19
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction at rest, measured by gated SPECT	6 months

Secondary Outcome Measures

Name	Time	Method
changes in LVM index, LVEDV, LVESV	6 months
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

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of