MSB Trading - Aug 2020 on, page-767

I think its pretty clear here .It doesnt work !!


Although these assays are consistent with the hypothesized mechanism of action of
immunomodulatory activity, this mechanism of action has not been demonstrated in the clinical
BLA 125706
ODAC Briefing Document Remestemcel-L: CMC
7
trials submitted to support licensure. While remestemcel-L and other MSC-based investigational
products have demonstrated apparent immunomodulatory effects in in vitro experiments, the
ability of remestemcel-L to reduce inflammation as measured by inflammatory biomarkers in
humans receiving the product has not been demonstrated. SR-aGVHD is thought to be an
immune-mediated disorder but its etiology is complex and many cell types are likely to be
involved in its pathogenesis. Therefore, any efficacy remestemcel-L might have in treating this
disease is not sufficient to demonstrate the product’s mechanism of action.