the safety is a big reason for being able to fast track clinical trials.
Efficacy becomes the key issue. Interesting that MSB has focused on the area of the body that regenerates least well, and is essential for life, and has huge unmet demand.
Also the non-autologous nature of MPCs mean that older candidates, or more damaged candidates benefit more greatly from those stem cells from a high quality healthy and young donor. This reflects what Prof Iltescu was saying at the AGM and it's very exciting.
The other thing is that the heart trials are targeting a very lucrative market.
Very helpful video. Also there is no suggestion that there are problems scaling up as @Fruitbat2 was claiming in another thread...., he just mentioned taking the stem cells and culturing them. There must be different ways of identifying, selecting and treating them which is where the patent rights are. But the culturing which is synonymous with manufacture does not seem problematic according to this guy.
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