Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery

NCT ID: NCT02870933

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-04-30

Brief 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

subject

this arm will receive Transepicardial with Transseptal CD 133+ Implantation

Group Type: EXPERIMENTAL

Transepicardial with Transseptal CD 133+ Implantation

Intervention Type: BIOLOGICAL

Transepicardial with Transseptal CD 133+ Implantation

control

this arm will not receive Transepicardial with Transseptal CD 133+ Implantation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transepicardial with Transseptal CD 133+ Implantation

Transepicardial with Transseptal CD 133+ Implantation

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• patients with coronary artery disease 3 vessels disease indicated for CABG
• LVEF < 35% which has been confirmed by MRI
• Patients with akinetic or hypokineic segment, and left ventricle myocardial hypoperfusion confirmed in MRI
• has signed informed consent

Exclusion Criteria

Emergency CABG Ungraftable coronary artery Acute myocardial Infarct (<14 days) Valve disease which need surgery repair Contraindicated for MRI High degree ventricular arrhytmia Coagulation disorder HIV positive patient, Hepatitis B + patients, HCV + patients AST/ALT > 1,5 upper normal value Creatinine > 2 g/dl. Malignancy

Drop out criteria :

Aortic cross clamp >120 minutes and CABG total time >180

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role: lead

Responsible Party

Tri Wisesa Soetisna, MD, MHA

Director of Human Capital and General Affairs of National Cardiac Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tri Wisesa Soetisna, MD, MHA

Role: PRINCIPAL_INVESTIGATOR

National Cardiovascular Center Harapan Kita

Locations

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LB.02.01/VII/086/KEP.007.EV

Identifier Type: -

Identifier Source: org_study_id