Not sure if this has been posted before however it deserves a new thread.
https://www.nature.com/articles/s41409-021-01442-3?proof=t%2525C2%2525A0Some interesting discussion on the other site .yesterdayThe mechanism of action of MSCs in reducing GVHD is not entirely clear and may be multifactorial. In vitro, MSCs have several immunomodulatory properties and reduce the secretion of inflammatory cytokines such as IFNγ and TNFα by alloreactive T cells [8]. In vivo, infusion of MSCs reduced the expansion of donor T cells and reduced damage in target organs in experimental GVHD models [9]. It is possible that remestemcel-L exerts its beneficial effect through a number of mechanisms, including wound healing properties in the GI tract, since the analysis of MAPs shows that GI crypt damage was quite extensive at the initiation of remestemcel-L therapy and that the large majority of these study patients not only experienced clinical responses within 28 days but 87% were able to discontinue immunosuppressive therapy within 6 months [1].
In summary, nearly one half of pediatric patients with SR acute GVHD at the initiation of remestemcel-L therapy were diagnosed with severe lower GI disease as measured by MAP, and 64% of these patients survived, compared to 10% of patients with SR acute GVHD and high MAPs from the MAGIC database. These findings support and extend the recently published results that showed that children with severe, SR acute GVHD benefit from remestemcel-L therapy.Brilliant !
Look at the response rate and consider how easy it would be to make sure that every batch has the required efficacy that the FDA mandate. Out of every 10 people treated just 1 patient may have responded with out our treatment .
Is this the reason SI is so confident?
Justified in my opinion.
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