Clinical trial NCT01187654: Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myocardial Infarction
Keywords: myocardial infarction
bone marrow stem cell
AC133
mono nuclear cell
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Increase from baseline in ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: Decrease LVESV/LVEDV/LVM index
timeFrame: 6 months
measure: Decrease the number of Non Viable segments from baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan institute
Study officials:
affiliation: Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Royan Institute
name: Masoud Ghassemi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royan Institute
name: Nasser Aghdami, PhD,MD
role: STUDY_DIRECTOR
affiliation: Royan Institute
name: Davood Kazemi saleh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royan Institute
name: Hossein Baharvand, PhD
role: PRINCIPAL_INVESTIGATOR
References: