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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Ankara University
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- ventricular remodeling
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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
- •Hematological diseases
- •Socially and mentally disabilities
Outcomes
Primary Outcomes
ventricular remodeling
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Alp Can
Prof. Dr.
Ankara University