Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01167751
First received: July 19, 2010
Last updated: July 15, 2012
Last verified: July 2010
  Purpose

One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure.

One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function.

The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.


Condition Intervention Phase
Myocardial Infarction
Biological: MNC
Biological: AC 133
Biological: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Left ventricular ejection fraction at rest, measured by Dobutamine Stress Echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • changes in LVM index, LVEDV, LVESV [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 105
Study Start Date: January 2008
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MNC implantation
Implantation of BM derived MNC
Biological: MNC
Implantation of BM derived MNC
Other Name: MNC injection
Experimental: AC 133 implantation
Implantation of BM derived AC 133
Biological: AC 133
Implantation of BM derived AC133
Other Name: AC133 injection
Placebo Comparator: Control
Injection of cell carrier
Biological: Control
Injection of cell carrier
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CABG candidate
  • 4 or more than 4 viable segment
  • First anterior heart attack whit in 21 days to 3 month.
  • St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography.
  • The target lesion had to be located in the left anterior descending (LAD) section.
  • Myocardium thickness more than 3 mm.
  • Negative pregnancy test (in women with child bearing potential)

Exclusion Criteria:

  • History of prior anterior myocardial infarction:
  • Patient with regional wall motion abnormalities in the non-infarct region prior CABG
  • Patient with anterior etiology of LV dysfunction (Known/ suspected non ischemic cardiomyopathy, previous anthracycline, known ethanol abuse (greater than 6 0z. Ethanol / day on a regular basis.
  • Patient with significant valve disease defined as stenosis or regulation graded as greater than moderate (2+)
  • Poor echocardiography window.
  • Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l
  • Documental terminal illness or malignancy.
  • Previous bone marrow transplant
  • Autoimmune disease (e. g Lupus, Multiple sclerosis)
  • Any contraindication for bone - marrow aspiration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167751

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Royan Institute
Principal Investigator: Hossein Baharvand, PhD Royan Institute
Principal Investigator: Mohammadhassan Nasseri, MD Baghiatollah
Study Director: Nasser Aghdami, MD, PhD Royan Institute
  More Information

Additional Information:
Publications:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01167751     History of Changes
Other Study ID Numbers: Royan-Heart-001
Study First Received: July 19, 2010
Last Updated: July 15, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Myocardial infarction
Bone marrow stem cells
AC133

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014