NCT02323477

Human Umbilical Cord Stroma MSC in Myocardial Infarction

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ankara University · Academic / Other
• Sex: Male
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	stem cell transplantation	Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation

Timeline

• Start date: 2015-02-02
• Primary completion: 2018-09-30
• Completion: 2018-12-30
• First posted: 2014-12-23
• Last updated: 2020-07-10

Locations

1 site across 1 country: Turkey (Türkiye)