Human Umbilical Cord Stroma MSC in Myocardial Infarction

Study Overview
=================
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.

Official Title
-----------------
The Efficacy and Safety Assessment of Human Umbilical Cord Stroma-derived Multipotent Stromal Cells in Myocardial Infarction; a Phase 1/2 Clinical Trial (HUC-HEART Study)

Conditions
-----------------
Chronic Ischemic Cardiomyopathy, Coronary Artery Bypass Surgery

Intervention / Treatment
-----------------
* Biological: stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic umbilical cord MSC group<br>Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45) | Biological: stem cell transplantation<br>* Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation<br>|
| Active Comparator: Autologous bone marrow-derived MNC group<br>Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45) | Biological: stem cell transplantation<br>* Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation<br>|
| No Intervention: Control group<br>20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventricular remodeling | 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). | within one year after cell transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cellular therapy, chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord multipotent stem cell, human umbilical cord mesenchymal stem cell, ischemic heart disease, bone marrow mononuclear cell, allogeneic stem cell transplantation