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Human Umbilical Cord Stroma MSC in Myocardial Infarction

NCT02323477 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-07-10

No results posted yet for this study

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.

Conditions

  • Chronic Ischemic Cardiomyopathy
  • Coronary Artery Bypass Surgery

Interventions

BIOLOGICAL

stem cell transplantation

Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Sponsors & Collaborators

  • Hacettepe University

    collaborator OTHER

  • Turkiye Yuksek Ihtisas Education and Research Hospital

    collaborator OTHER_GOV

  • Atigen-Cell and Tissue Center

    collaborator INDUSTRY

  • Dr. Sami Ulus Children's Hospital

    collaborator OTHER

  • Ankara Yildirim Beyazıt University

    collaborator OTHER

  • Ankara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-02
Primary Completion
2018-09-30
Completion
2018-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323477 on ClinicalTrials.gov