Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient

Royan Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Biological: MNC; Biological: AC133; Biological: CONTROL

Study type: Interventional

Funder types: Other

Identifiers

NCT01187654

Royan-Heart-002

Details and patient eligibility

About

Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure.

This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending (LAD) involvement.

Full description

Patient from both gender, who had acute MI within recent 3 Weeks in LAD territory and would underwent PCI are eligible for this study. The bone marrow derived AC 133+ and MNC would be intracoronary injected to the patients during PCI procedure. The control group would be received just serum during PCI. The patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan.

The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI> 30
• First acute MI in LAD territory
• St elevation MI
• Ejection fraction: 20-45%
• at least two non - mobile or less mobile segment of left ventricular myocard.
• Successful PCI with stenting

Exclusion criteria

• Multivessel ceremony artery disease
• Pulmonary edema
• SBP < 80 mmHg
• Thrombocytopenia (PLT < 50, 000)
• INR > 2
• Hepatic failure or dysfunction
• Renal failure or dysfunction
• Positive HIV Ab/ HBC Ab/ HCV Ab/ HSV Ag
• Documental terminal illness
• Documental Malignancy
• Patient with sever coronary disease and unstability of vital sign
• History of leukopenia, Anemia, hepatic or renal dysfunction or malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

AC133 recipients

Experimental group

Description:

intra coronary injection of bone marrow derived AC133+ cells

Treatment:

Biological: AC133

MNC recipients

Experimental group

Description:

intra coronary injection of bone marrow derived MNC

Treatment:

Biological: MNC

control

Active Comparator group

Description:

injection of autologous serum

Treatment:

Biological: CONTROL