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Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167751
First Posted: July 22, 2010
Last Update Posted: June 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
  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
Intervention Model: Parallel Assignment
Masking: Single (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 gated SPECT [ Time Frame: 6 months ]

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 ]
  • changes in LVM index, LVEDV, LVESV [ Time Frame: 6 months ]

Enrollment: 90
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CABG candidate
  • At least 4 akinetic segments
  • First anterior heart attack within in 10 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.

Exclusion Criteria:

  • History of prior anterior myocardial infarction:
  • History of prior CABG
  • 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.
  • Positive pregnancy test (in women with child bearing potential)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 19, 2010
First Posted: July 22, 2010
Last Update Posted: June 21, 2016
Last Verified: July 2010

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