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

Myocardial Infarction Clinical Trial

Official title:

Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187654
• Other study ID #: Royan-Heart-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 18, 2010
• Last updated: December 25, 2012
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: August 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

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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:
• AC133
intra coronary injection of bone marrow derived AC133+ cells
• MNC
intra coronary injection of bone marrow derived MNC
• CONTROL
autologous serum injection

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase from baseline in ejection fraction		6 months	Yes
Secondary	Decrease LVESV/LVEDV/LVM index	left ventricular end systolic volume (LVESV) left ventricular end diastolic volume (LVEDV) Left Ventricular mass (LVM)	6 months	No
Secondary	Decrease the number of Non Viable segments from baseline		6 months	Yes