Might have been a sliding doors moment. We'll never know. It's...

Might have been a sliding doors moment. We'll never know.

It's not my field, but this is one of the reasons why I feel FDA doesn't value the implications of the safety record of non-engrafting MSCs anywhere near enough. Or at least it hasnt up until now. The role of apoptosis and what happens to MSCs during efferocytosis doesn't get much of a mention in FDA reasoning on MOAs of any of our products.

It seems to me they still haven't come to grips with the difference of approach necessary when moving between haematopoietic and non-haematopoietic cells here. What I mean is the FDA is OK with measuring functional improvement brought on by autologous haematopoietic cells (i.e. measured by their rate and durability of cell engraftment), but they then seem to port the same or similar concepts over to Mesoblast's non-haematopoietic MSCs whose functional benefits are all benefiting from - and IMO dependent on - their non-engraftment. The body gets rid of them. Quickly. And demonstrably, after theyve done their thing.

So, these fears that get trotted out by FDA reviewers & other commentators about heterogeneity of donor material etc can seem to me a bit off the point - perhaps because there's a lack of appreciation of the need for a difference of approach, or even some confusion with the perceived target benefit of autologous (vs allogeneic) haematopoietics in the same space.

Getting back to the ARDS trial, I see no reason why these highly safe allogeneic cells shouldnt have been used in its proper continuance (under Government funding and programs). No downside. But I guess politics moves on.

Now, if only we had a regenerative aspect to our MSCs. That would get & hold everyone's attention.

Cheers
Have a good one