search
Back to results

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

Primary Purpose

Chronic Ischemic Cardiomyopathy, Coronary Artery Bypass Surgery

Status
Terminated
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
stem cell transplantation
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ischemic Cardiomyopathy focused on measuring 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

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alp Can

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Allogeneic umbilical cord MSC group

Autologous bone marrow-derived MNC group

Control group

Arm Description

Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)

Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)

20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 18, 2014
Last Updated
July 8, 2020
Sponsor
Ankara University
Collaborators
Hacettepe University, Turkiye Yuksek Ihtisas Education and Research Hospital, Atigen-Cell and Tissue Center, Dr. Sami Ulus Children's Hospital, Ankara Yildirim Beyazıt University
search

1. Study Identification

Unique Protocol Identification Number
NCT02323477
Brief Title
Human Umbilical Cord Stroma MSC in Myocardial Infarction
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to budget limitations as allocated for a given period.
Study Start Date
February 2, 2015 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
Collaborators
Hacettepe University, Turkiye Yuksek Ihtisas Education and Research Hospital, Atigen-Cell and Tissue Center, Dr. Sami Ulus Children's Hospital, Ankara Yildirim Beyazıt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ischemic Cardiomyopathy, Coronary Artery Bypass Surgery
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allogeneic umbilical cord MSC group
Arm Type
Experimental
Arm Description
Allogeneic human umbilical cord MSCs will be transplanted to 39 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)
Arm Title
Autologous bone marrow-derived MNC group
Arm Type
Active Comparator
Arm Description
Autologous bone marrow-derived MNCs will be transplanted to 20 male patients (age 30-80) intramyocardially during CABG in chronic ischemic cardiomyopathy (EF<%45)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
20 male patients (age 30-80) undergoing CABG in chronic ischemic cardiomyopathy (EF<%45) whom will not received any further transplantation
Intervention Type
Biological
Intervention Name(s)
stem cell transplantation
Intervention Description
Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation
Primary Outcome Measure Information:
Title
ventricular remodeling
Description
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).
Time Frame
within one year after cell transplantation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Alp Can
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32840230
Citation
Ulus AT, Mungan C, Kurtoglu M, Celikkan FT, Akyol M, Sucu M, Toru M, Gul SS, Cinar O, Can A. Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial). Int J Stem Cells. 2020 Nov 30;13(3):364-376. doi: 10.15283/ijsc20075.
Results Reference
derived
PubMed Identifier
26123356
Citation
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.
Results Reference
derived

Learn more about this trial

Human Umbilical Cord Stroma MSC in Myocardial Infarction

We'll reach out to this number within 24 hrs