Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
This study has been completed.
Sponsor:
Royan Institute
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01167751
First received: July 19, 2010
Last updated: July 15, 2012
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Biological: MNC Biological: AC 133 Biological: Control |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Royan Institute:
Primary Outcome Measures:
- Left ventricular ejection fraction at rest, measured by Dobutamine Stress Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- changes in LVM index, LVEDV, LVESV [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 105 |
| Study Start Date: | January 2008 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MNC implantation
Implantation of BM derived MNC
|
Biological: MNC
Implantation of BM derived MNC
Other Name: MNC injection
|
|
Experimental: AC 133 implantation
Implantation of BM derived AC 133
|
Biological: AC 133
Implantation of BM derived AC133
Other Name: AC133 injection
|
|
Placebo Comparator: Control
Injection of cell carrier
|
Biological: Control
Injection of cell carrier
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167751
Locations
| Iran, Islamic Republic of | |
| Royan Institute | |
| Tehran, Iran, Islamic Republic of | |
Sponsors and Collaborators
Royan Institute
Investigators
| Study Chair: | Hamid Gourabi, PhD | Royan Institute |
| Principal Investigator: | Hossein Baharvand, PhD | Royan Institute |
| Principal Investigator: | Mohammadhassan Nasseri, MD | Baghiatollah |
| Study Director: | Nasser Aghdami, MD, PhD | Royan Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Royan Institute |
| ClinicalTrials.gov Identifier: | NCT01167751 History of Changes |
| Other Study ID Numbers: | Royan-Heart-001 |
| Study First Received: | July 19, 2010 |
| Last Updated: | July 15, 2012 |
| Health Authority: | Iran: Ethics Committee Iran: Ministry of Health |
Keywords provided by Royan Institute:
|
Myocardial infarction Bone marrow stem cells AC133 |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013