Chronic Ischemic Cardiomyopathy, Coronary Artery Bypass Surgery
Conditions
Keywords
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
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.
Interventions
BIOLOGICALstem cell transplantation
Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation
Sponsors
Hacettepe University
Turkiye Yuksek Ihtisas Education and Research Hospital
Atigen-Cell and Tissue Center
Dr. Sami Ulus Children's Hospital
Ankara Yildirim Beyazıt University
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Turkey (Türkiye)
Outcome results
None listed