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: June 19, 2016
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 gated SPECT [ 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: 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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 19, 2016
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 August 23, 2016