"Over the past 25 years the infusion procedures have exhibited an excellent safety profile, so much so that there are now over 950 registered MSC clinical trials listed with the FDA." https://www.nature.com/articles/s41536-019-0083-6, Published: 02 December 2019
It is not the first iPSC-derived therapy (e.g. FATE's iPSC CAR-T-cell therapy back in 2020), but it is the first iPSC-derived MSC therapy to obtain FDA IND application clearance out of the 950 registered MSC clinical trials with the FDA I believe. I have mentioned a few competitors in this space back in November 2021 of which I haven't seen any updates re IND clearance: https://hotcopper.com.au/threads/stem-cell-news.6079471/page-190?post_id=57668865
With that cleared IND, either Cynata or potential partner/s targeting the US market now have the opportunity to gain faster approval for clinical trials in the US, given the same CMC - as long as there is enough pre-clinical data to support it. And there appears to be a few on here:
Maybe we get an update on our IPF pre-clinical study at Monash soon, which was due to complete on 30 September 2021 and was initially our target for a US trial, before GvHD was handed back to us. CLI also very promising, given the pre-clinical data and the fact that the trial has already been approved in the UK and AU, just before COVID hit.
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