Human Umbilical Cord Stroma MSC in Myocardial Infarction (HUC-HEART)

Ankara University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Chronic Ischemic Cardiomyopathy; Coronary Artery Bypass Surgery

Treatments: Biological: stem cell transplantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02323477

741.STZ.2014

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Male

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 3 patient groups

Allogeneic umbilical cord MSC group

Experimental group

Description:

Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)

Treatment:

Biological: stem cell transplantation

Autologous bone marrow-derived MNC group

Active Comparator group

Description:

Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF\<%45)

Treatment:

Biological: stem cell transplantation

Control group

No Intervention group

Description:

20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF\<%45) whom will not received any further transplantation