Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Heart Failure has several etiologies and one of them is coronary artery disease. Coronary
      artery bypass grafting (CABG) is one of revascularizations method which has been used for
      decades in coronary artery disease theraphy. However, data about coronary artery bypass
      grafting shows that post-CABG patients still have low ejection fraction. For the last decade,
      there have been a lot of studies about the using of stem cells to increase heart
      contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone
      marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells
      is given during CABG by injection transepicardial and transseptal. The purpose of this study
      is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem
      cells can improve myocardial perfusion in patient with low ejection fraction following CABG
      surgery.
    

Detailed description: 
      Study sample : patient with low ejection fraction indicated for CABG surgery in NCCHK who
      fulfill inclusion and exclusion criteria

      Sampling method : first we use consecutive method to find subject with male sex and age
      40-70. After that, we use simple random sampling to allocate each subject to each group.

      Total samples is 13 for each group. To anticipated drop out rate 10%, total sample is 15 for
      each group.

      Intervention and measurement :

      Control group will only receive CABG surgery. Study group will receive CBAG surgery and stem
      cell implantation. Stem cell aspiration will be performed 1 day before CABG procedure. Before
      aspiration, patients will be given local anesthetic and light sedation. Stem cell will be
      collected from posterior iliac crest. Total aspirate 190 cc. Stem cell CD133+ will be
      separated using CliniMACS® Magnetic Separation Device after labelled with Magnetic microbeads
      - anti CD133 labelling.

      Myocardial perfusion reserve index will be measure using MRI. MPRI value will be obtained
      globally and segmentally in each 16 ventricle segments VEGF plasma level will be measured
      using sandwich Enzyme-linked Immunosorbent Assay method.

      Ejection fraction, left ventricle dimension, and scar size will be measured using MRI.

      Quality of life will be measured using Minnesota Living With Heart Failure Questionnaire.

      Statistical analysis is done using IBM SPSS Statistics version 21.0 (SPSS inc, Chicago, IL,
      USA). Numerical data will be presented in either mean/standard deviation or median/min-max
      depend on distribution of data. Hypothesis test for numeric variable is done using
      paired/non-paired T test or Mann-Whitney/Wilcoxon depend on normality of data. Normality test
      is done using Shapiro-Wilk test. Hypothesis test for category varible is done using
      chi-square or fischer test.
    

Intervention name(s): Transepicardial with Transseptal CD 133+ Implantation
Intervention type(s): Biological
Intervention description(s): Transepicardial with Transseptal CD 133+ Implantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD 133+; Transepicardial with Transseptal Implantation; CABG