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OpenTrials
Completed

NCT Number: NCT01187654

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royan institute

Tehran, Iran

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC133

Biological

intra coronary injection of bone marrow derived AC133+ cells

Other names: AC133 injection

MNC

Biological

intra coronary injection of bone marrow derived MNC

Other names: MNC injection

Control

Biological

autologous serum injection

Other names: placebo injection

Primary outcomes

  1. Increase from baseline in ejection fraction

    Time frame: 6 months

Secondary outcomes

  1. 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)

  2. Decrease the number of Non Viable segments from baseline

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2010
Registry last updated
Dec 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.