Challenges between clinical sites and cell therapy facilities in the excellent trial (expanded cell endocardiac transplantation), a phase I/IIb clinical trial

      Introduction: Autologous injection of Peripheral Blood CD34+ stem cells during a CABG surgery previously brought positive outcomes in AMI patients. CellProthera set the StemXpand technology that expands peripheral blood CD34+ stem cells, with one StemPack kit per patient. The medical device was validated with inter-sites manufacturing comparisons, to prove the reproducibility and the robustness of our process. The named ProtheraCytes IND is injected via the BIOCARDIA device. The American and European regulatory Authorities named this type of cellular compounds MTMM (More Than Minimally Manipulated) or ATMP (Advanced Therapy Medicinal Product). This breakthrough approach circumscrible the patient from leukapheresis and CABG surgery.
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