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Clinical Trial Summary

The purpose of the pilot study is to evaluate the safety and the individual efficacy of the use of ProtheraCytes® in patients with acute myocardial infarction and decreased ejection fraction. CD34+ cells will be re-injected using a dedicated catheter pushed through the femoral artery up to the left ventricle, thus avoiding open chest surgery.


Clinical Trial Description

Primary Objective : The objective is to establish the safety of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34+ stem cells (ProtheraCytes®) in AMI patients with a LVEF≤45% after PTCA and stent(s) implantation. Secondary Objective : The objective is to establish the individual efficacy of the interventional procedure beginning at the first G-CSF administration to 6 months after the injection of autologous expanded CD34+ stem cells (ProtheraCytes®) in AMI patients with a LVEF≤45% after PTCA and stent(s) implantation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04198883
Study type Interventional
Source CellProthera
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date November 27, 2018
Completion date July 31, 2021

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