Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167751
• Other study ID #: Royan-Heart-001
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2010
• Last updated: June 19, 2016
• Start date: January 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Biological:
• MNC
Implantation of BM derived MNC
• AC 133
Implantation of BM derived AC133
• Control
Injection of cell carrier

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction at rest, measured by gated SPECT		6 months	Yes
Secondary	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	Yes
Secondary	changes in LVM index, LVEDV, LVESV		6 months	Yes

External Links

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