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%
after reperfusion versus standard of care.
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.
Acute Myocardial Infarction
Standard of Care (Percutaneous Transluminal Coronary Angioplasty and stent(s) implantation),
Standard Treatment for CHF post AMI
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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