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

NCT02870933 | Completed Phase 4 Results DMC

• 1 other identifier: LB.02.01/VII/086/KEP.007.EV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CD 133+; Transepicardial with Transseptal Implantation; CABG

Outcome Measures

Primary Outcomes (2)

• Myocardial Defect Perfusion

  Number of heart wall segments with perfusion defect measured by MRI.

  Baseline, 6 months

• Left Ventricular Ejection Fraction

  Left ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges \< 41%

  Baseline, 6 months

Secondary Outcomes (7)

• Six Minutes Walking Test

  Baseline, 6 months

• Wall Motion Score Index

  Baseline, 6 months

• Myocardial Scar Size

  Baseline, 6 months

• Vascular Endothelial Growth Factor

  Baseline, 6 months

• Left Ventricle End Systolic Volume

  Baseline, 6 months

Study Arms (2)

subject

EXPERIMENTAL

this arm will receive Transepicardial with Transseptal CD 133+ Implantation

Biological: Transepicardial with Transseptal CD 133+ Implantation

control

NO INTERVENTION

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

Interventions

Transepicardial with Transseptal CD 133+ Implantation BIOLOGICAL

Transepicardial with Transseptal CD 133+ Implantation

subject

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Tri Wisesa Soetisna, M.D, MHA, PhD
• Organization: National Cardiovascular Center Harapan Kita

tricts2000@yahoo.com

+62215684093

Study Officials

• Tri Wisesa Soetisna, MD, MHA

  National Cardiovascular Center Harapan Kita

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Human Capital and General Affairs of National Cardiac Center

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: August 17, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 2, 2020
• Results First Posted: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)