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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323477
Recruitment Status : Terminated (Due to budget limitations as allocated for a given period.)
First Posted : December 23, 2014
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
Hacettepe University
Turkiye Yuksek Ihtisas Education and Research Hospital
ATIGEN-CELL
Dr. Sami Ulus Children's Hospital
Ankara Yildirim Beyazıt University
Information provided by (Responsible Party):
Alp Can, Ankara University

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 23, 2014
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE February 2, 2015
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2014)
ventricular remodeling [ Time Frame: within one year after cell transplantation ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord Stroma MSC in Myocardial Infarction
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Ischemic Cardiomyopathy
  • Coronary Artery Bypass Surgery
Intervention  ICMJE Biological: stem cell transplantation
Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation
Study Arms  ICMJE
  • Experimental: Allogeneic umbilical cord MSC group
    Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)
    Intervention: Biological: stem cell transplantation
  • Active Comparator: Autologous bone marrow-derived MNC group
    Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)
    Intervention: Biological: stem cell transplantation
  • No Intervention: Control group
    20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation
Publications * Can A, Ulus AT, Cinar O, Topal Celikkan F, Simsek E, Akyol M, Canpolat U, Erturk M, Kara F, Ilhan O. Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting. Stem Cell Rev Rep. 2015 Oct;11(5):752-60. doi: 10.1007/s12015-015-9601-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 8, 2020)
46
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2014)
79
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02323477
Other Study ID Numbers  ICMJE 741.STZ.2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alp Can, Ankara University
Study Sponsor  ICMJE Ankara University
Collaborators  ICMJE
  • Hacettepe University
  • Turkiye Yuksek Ihtisas Education and Research Hospital
  • ATIGEN-CELL
  • Dr. Sami Ulus Children's Hospital
  • Ankara Yildirim Beyazıt University
Investigators  ICMJE Not Provided
PRS Account Ankara University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP