Ann: COVID-19 ARDS & GVHD Update, Quarterly Report & Appendix 4C, page-58

ODAC Briefing Document Remestemcel-L: CMC
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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.