Human Umbilical Cord Stroma MSC in Myocardial Infarction

Phase 1

Terminated

• Conditions: Chronic Ischemic Cardiomyopathy; Coronary Artery Bypass Surgery
• Interventions: Biological: stem cell transplantation

• Registration Number: NCT02323477
• Lead Sponsor: Ankara University

Brief Summary

The purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hUCS-MSCs) in myocardial infarction (MI). All subjects will be taken into the bypass coronary surgery prior to the cell administration. This 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous BM-MNCs (n=20), and third group (n=39) will be receiving allogeneic hUCS-MSCs. In all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. The infarct zone will be determined by the MR, SPECT and PET imaging. Only male subjects between 30-80 years of age. The efficiency of the therapy will be evaluated according to the parameters measured by MR, SPECT, and Echocardiography. All subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-23
• Study Start: 2015-02-02
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

• Ischemic hearth disease who will experience CABG
• %25<EF<%45
• NYHA class II-IV patients
• hemodynamically stable

Exclusion Criteria

• Patient's in approval
• Acute cardiac decompensation
• Acute myocardial infarction
• Congenital heart disease
• Additional surgical heart disease other than coronary artery disease
• Malign arrhythmia
• All malignancies
• HbA1c level >%10 (86 mmol/mol) type II diabetes mellitus
• Severe liver dysfunction
• Severe COPD
• Coagulopathy
• Immunosuppressive treatment
• Acute hepatitis, hepatitis B, C and HIV infection
• Chronic liver and renal failure
• Collagen tissue disease
• Stroke
• TB
• Hematological diseases
• Socially and mentally disabilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allogeneic umbilical cord MSC group	stem cell transplantation	Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)
Autologous bone marrow-derived MNC group	stem cell transplantation	Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)

Primary Outcome Measures

Name	Time	Method
ventricular remodeling	within one year after cell transplantation	Outcome measures will be determined by cardiac MR, SPECT and PET monitoring to assess the left ventricular ejection fraction (%), left ventricle end-diastolic and end-systolic volumes (mL/m2), left ventricle mass (g/m2), infarct size (%), and the thickness of the dysfunctional wall (mm).

Trial Locations

Locations (1)

Alp Can; 🇹🇷 Ankara, Turkey