"This is obviously not enough for the FDA..who wanted potency...

"This is obviously not enough for the FDA..who wanted potency assays developed which identify not just T Cell suppression but could ensure consistent cell characterisation via a potency assay that would speak to the health and viability of the MSCs."

Without accepting your other premises which I don't - I wonder if you understand that its not T Cell suppression that matters (T cells can be regulatory or helper (to define two counter working categories) - in the GVHD milieu you want MORE regulatory T cell activity and LESS helper T cell activity - to talk of T cell suppression without breaking out those two contrary actions of two different types of T cells) seems just mistaken to me.

There is research done by Aggarwahl and Pittenger (which MSB cite in their recent academic and patent applications - despite that its from 2005) that goes into this a bit.

Its pointless, I submit to you otherperspective, to get hung up on measuring Interleukin 2 or cd25 unless you understand what is being measured - are you measuring T regs as well as T helper cells or not ?

I wonder if you even understand what I'm saying.


"I read general research on MSC harvesting in the past regarding factors such as shear stress, confluence rates , different cryopreservation techniques, washing off growth media , concentration and packaging all of which can affect or damage the TLR receptors on MSCS reducing potency entirely independent of the purity of the cells themselves."

TLR - I would interpret if I read it in a cell biol paper as being to Toll-Like Receptors - but I think you have made a typo - I think you mean TNF R 1. Tumor necrosis factor receptor 1 - which is the receptor for TNF alpjha.

Respectfully, MSB have included words like substantial and significant in their announcement describing what they've done - those are subjective words.

If you want to understand what MSB might be doing and what they cannot possibly be doing - you need to be able to unpack some of the methods behind what they don't say in lay communications.

When molecules are measured techniques are used. Fluorescent Activated Cell Sorting - uses antibodies. ELISA likewise. The molecules being measured and how they are measured matters.

One has to measure the right stuff the right way.

AND to draw valid statistical inferences one has to have enough data to do that.