Phase 4
N=30
Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02870933 ↗Enrolled (actual)
30
Serious AEs
11.5%
Results posted
Apr 2020
Primary outcome: Primary: Myocardial Defect Perfusion — 15.76; 15.38; 2.08; 3.85 Percentage of Myocardial Perfusion
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Transepicardial with Transseptal CD 133+ Implantation (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Defect Perfusion |
15.76; 15.38; 2.08; 3.85 | — |
| PRIMARY Left Ventricular Ejection Fraction |
25.88; 30.18; 34.58; 31.62 | — |
| SECONDARY Six Minutes Walking Test |
299; 298; 420; 378 | — |
| SECONDARY Wall Motion Score Index |
2.32; 2.07; 1.82; 2.08 | — |
| SECONDARY Myocardial Scar Size |
27.76; 24.45; 25.46; 27.32 | — |
| SECONDARY Vascular Endothelial Growth Factor |
46.86; 40.46; 61.05; 19.88 | — |
| SECONDARY Left Ventricle End Systolic Volume |
115.87; 141.05; 126.91; 149.33 | — |
| SECONDARY Minnesota Living With Heart Failure Questionnaire |
27; 23; 12; 14 | — |
| SECONDARY Left Ventricle End Diastolic Volume |
156.10; 200.89; 183.68; 219.97 | — |
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.
Eligibility Criteria
Inclusion Criteria
- patients with coronary artery disease 3 vessels disease indicated for CABG
- LVEF 1, 5 upper normal value Creatinine > 2 g/dl. Malignancy
Drop out criteria :
Aortic cross clamp >120 minutes and CABG total time >180
Data sourced from ClinicalTrials.gov (NCT02870933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.