They were of course always going to but the FDA is fighting the decision by a California District Court that the California Stem Cell Treatment Center (CSCTC)’s medical procedure that utilised patients’ personal stem cells did not actually fall under the FDA’s authority.
https://bioedge.org/stem-cells/regulating-dodgy-stem-cell-clinics-fda-is-appealing-against-ruling/
As I have said before, OCC could in effect begin practicing its autologous stem cell therapy, ATI, in the US right now, but it will not. It will commence phase III trials, as it has stated and if it does not announce a US/global partner in that, I would be very surprised.
In the mean time, the right of FDA regulation over patients own cells could become a bit of a legal quagmire. I always thought the bible bashers in the US would be more of a hurdle in therapies that involve cellular manipulation (the "playing God" argument). Whilst COVID was a big spanner in the works of young bio-tech firms like OCC, ironically the sheer deluge of cellular based therapies that have come through since has pretty much drowned that risk.
More specifically the list of stem-cells approvals in 2022 by the FDA has been surprisingly extensive:
https://ipscell.com/2021/03/list-of-fda-approved-stem-cell-therapies/
They were of course always going to but the FDA is fighting the...
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