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

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ClinicalTrials.gov Identifier: NCT02323477
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : January 25, 2017
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

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.

Condition or disease Intervention/treatment Phase
Chronic Ischemic Cardiomyopathy Coronary Artery Bypass Surgery Biological: stem cell transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : February 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
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)
Biological: stem cell transplantation
Human allogeneic umbilical cord MSC or autologous BM-MNC 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)
Biological: stem cell transplantation
Human allogeneic umbilical cord MSC or autologous BM-MNC 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



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323477


Locations
Turkey
Alp Can Recruiting
Ankara, Turkey, 06100
Contact: Alp Can, M.D., Ph.D.    +903125958169    alpcan@medicine.ankara.edu.tr   
Contact: A. Tulga Ulus, M.D.    +903123054344    uluss@yahoo.com   
Sponsors and Collaborators
Ankara University
Hacettepe University
Turkiye Yuksek Ihtisas Education and Research Hospital
ATIGEN-CELL
Dr. Sami Ulus Children's Hospital
Ankara Yildirim Beyazıt University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alp Can, Prof. Dr., Ankara University
ClinicalTrials.gov Identifier: NCT02323477     History of Changes
Other Study ID Numbers: 741.STZ.2014
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

Keywords provided by Alp Can, Ankara University:
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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiomyopathies
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases