Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

Royan Institute

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Biological: MNC; Biological: Control; Biological: AC 133

Study type: Interventional

Funder types: Other

Identifiers

NCT01167751

Royan-Heart-001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

MNC implantation

Experimental group

Description:

Implantation of BM derived MNC

Treatment:

Biological: MNC

AC 133 implantation

Experimental group

Description:

Implantation of BM derived AC 133

Treatment:

Biological: AC 133

Control

Placebo Comparator group

Description:

Injection of cell carrier

Treatment:

Biological: Control