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

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Biological: CONTROL; Biological: AC133; Biological: MNC

• Registration Number: NCT01187654
• Lead Sponsor: Royan Institute

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2009-05
• Status Verified: 2010-08
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-25
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	CONTROL	injection of autologous serum
AC133 recipients	AC133	intra coronary injection of bone marrow derived AC133+ cells
MNC recipients	MNC	intra coronary injection of bone marrow derived MNC

Primary Outcome Measures

Name	Time	Method
Increase from baseline in ejection fraction	6 months

Secondary Outcome Measures

Name	Time	Method
Decrease LVESV/LVEDV/LVM index	6 months	left ventricular end systolic volume (LVESV) left ventricular end diastolic volume (LVEDV) Left Ventricular mass (LVM)
Decrease the number of Non Viable segments from baseline	6 months

Trial Locations

Locations (1)

Royan institute; 🇮🇷 Tehran, Iran, Islamic Republic of