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

December 25, 2012 updated by: Royan Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AC133 recipients
intra coronary injection of bone marrow derived AC133+ cells
Biological: AC133
intra coronary injection of bone marrow derived AC133+ cells
Other Names:
  • AC133 injection
EXPERIMENTAL: MNC recipients
intra coronary injection of bone marrow derived MNC
Biological: MNC
intra coronary injection of bone marrow derived MNC
Other Names:
  • MNC injection
ACTIVE_COMPARATOR: control
injection of autologous serum
Biological: CONTROL
autologous serum injection
Other Names:
  • placebo injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase from baseline in ejection fraction
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Principal Investigator: Masoud Ghassemi, MD, Royan Institute
  • Study Director: Nasser Aghdami, PhD,MD, Royan Institute
  • Principal Investigator: Davood Kazemi saleh, MD, Royan Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (ESTIMATE)

August 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 27, 2012

Last Update Submitted That Met QC Criteria

December 25, 2012

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Heart-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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