Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
Information source: Royan Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction
Intervention: MNC (Biological); AC 133 (Biological); Control (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Royan Institute Official(s) and/or principal investigator(s): Hamid Gourabi, PhD, Study Chair, Affiliation: Royan Institute Hossein Baharvand, PhD, Principal Investigator, Affiliation: Royan Institute Mohammadhassan Nasseri, MD, Principal Investigator, Affiliation: Baghiatollah Nasser Aghdami, MD, PhD, Study Director, Affiliation: Royan Institute
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Left ventricular ejection fraction at rest, measured by Dobutamine Stress Echocardiography
Secondary outcome: Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiographychanges in LVM index, LVEDV, LVESV
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- CABG candidate
- 4 or more than 4 viable segment
- First anterior heart attack whit in 21 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.
- Myocardium thickness more than 3 mm.
- Negative pregnancy test (in women with child bearing potential)
Exclusion Criteria:
- History of prior anterior myocardial infarction:
- Patient with regional wall motion abnormalities in the non-infarct region prior CABG
- Patient with anterior etiology of LV dysfunction (Known/ suspected non ischemic
cardiomyopathy, previous anthracycline, known ethanol abuse (greater than 6 0z.
Ethanol / day on a regular basis.
- Patient with significant valve disease defined as stenosis or regulation graded as
greater than moderate (2+)
- 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.
Locations and Contacts
Royan Institute, Tehran, Iran, Islamic Republic of
Additional Information
Related publications: Ahmadi H, Baharvand H, Ashtiani SK, Soleimani M, Sadeghian H, Ardekani JM, Mehrjerdi NZ, Kouhkan A, Namiri M, Madani-Civi M, Fattahi F, Shahverdi A, Dizaji AV. Safety analysis and improved cardiac function following local autologous transplantation of CD133(+) enriched bone marrow cells after myocardial infarction. Curr Neurovasc Res. 2007 Aug;4(3):153-60.
Starting date: January 2008
Last updated: July 15, 2012
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