Human Umbilical Cord Stroma MSC in Myocardial Infarction

Coronary Artery Bypass Surgery Clinical Trial

— HUC-HEART  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02323477
• Other study ID #: 741.STZ.2014
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2, 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2020
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: December 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Ischemic Cardiomyopathy
• Coronary Artery Bypass Surgery
• Infarction
• Myocardial Infarction

Intervention

Biological:
• stem cell transplantation
Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Locations

Country	Name	City	State
Turkey	Alp Can	Ankara

Sponsors (6)

Lead Sponsor	Collaborator
Ankara University	Ankara Yildirim Beyazit University, ATIGEN-CELL, Dr. Sami Ulus Children's Hospital, Hacettepe University, Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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