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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Royan Institute

ClinicalTrials.gov Identifier:

NCT01187654

First received: August 18, 2010

Last updated: December 25, 2012

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 18, 2010

Last Updated Date

December 25, 2012

Start Date ^ICMJE

May 2009

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Increase from baseline in ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01187654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Decrease LVESV/LVEDV/LVM index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Myocardial Infarction

Intervention ^ICMJE

Biological: AC133
intra coronary injection of bone marrow derived AC133+ cells

Other Name: AC133 injection
Biological: MNC
intra coronary injection of bone marrow derived MNC

Other Name: MNC injection
Biological: CONTROL
autologous serum injection

Other Name: placebo injection

Study Arm (s)

Experimental: AC133 recipients
intra coronary injection of bone marrow derived AC133+ cells

Intervention: Biological: AC133
Experimental: MNC recipients
intra coronary injection of bone marrow derived MNC

Intervention: Biological: MNC
Active Comparator: control
injection of autologous serum

Intervention: Biological: CONTROL

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01187654

Other Study ID Numbers ^ICMJE

Royan-Heart-002

Has Data Monitoring Committee

Yes

Responsible Party

Royan Institute

Study Sponsor ^ICMJE

Royan Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Hamid Gourabi, PhD	Royan Institute
Principal Investigator:	Masoud Ghassemi, MD	Royan Institute
Study Director:	Nasser Aghdami, PhD,MD	Royan Institute
Principal Investigator:	Davood Kazemi saleh, MD	Royan Institute
Principal Investigator:	Hossein Baharvand, PhD	Royan Institute

Information Provided By

Royan Institute

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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