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Clinical Trial Summary

A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% versus standard of care.


Clinical Trial Description

The main purpose of this phase I/IIb is to evaluate the safety, the tolerance and the first efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells after automated ex-vivo expansion with the StemXpand machine) in patients with an acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected using a dedicated catheter , thus avoiding open chest surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02669810
Study type Interventional
Source CellProthera
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 25, 2015
Completion date June 2024

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