Below is a relevant extract from the article in the second link....

Below is a relevant extract from the article in the second link. MSB has provided FDA with results and data via successful Phase III to let the doctors treating patients and real world results decide if the product is better than the status quo. As we know holding your breath for FDA to approve is not wise.


With regard to the immune suppressing function of MSCs, this is in part due to a still incomplete understanding of the MSCs mechanisms of action in vivo in different disease contexts. Chinnadurai and colleagues have tested an in vitro assay matrix approach combining molecular, genetic and secretome analysis, elements of which could be deployed to define MSC immune modulatory potency (129). Indeed MSCs may need to respond to in vivo clues to become activated and unleash their full potential (113, 125). Moreover, recent data suggest that apoptosis of infused MSCs and their phagocytosis by macrophages, called efferocytosis, may trigger immunosuppressive cascades of events and may be more important than the direct immunosuppression by the MSCs themselves (133, 137, 138). Indeed the apoptosis of MSCs induced by the PBMCs of patients has been suggested to be a better predictor of in vivo MSC activity (138, 139).