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

July 8, 2020 updated by: Alp Can, Ankara University

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)

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Alp Can

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
within one year after cell transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Collaborators

Hacettepe University
Ankara Yildirim Beyazıt University
Dr. Sami Ulus Children's Hospital
Turkiye Yuksek Ihtisas Education and Research Hospital
Atigen-Cell and Tissue Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2015

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

July 10, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 741.STZ.2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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