Hi all and a Happy New Year from across the pond in Europe...
We all know that stem cells work from other studies/treatments/ companies etc so the efficacy of stem cells themselves is well known and well researched/documented. What we are more interested in is the use of the SVFC method of isolating and preparing stem cells in order to inject/infuse them back into the same patient without any adverse side effects.
So my question is does the whole IND process have to be followed rigorously or are we simply looking at a study to show that this method delivers high quality stem cells. If so, could the study that Andrews is conducting be a revised version of the IND process?
Given that the FDA are still kind of writing the policies on stem cell therapy, it's not too much of a leap to wonder if Andrews could be working with the FDA to investigate this and give them a better awareness of how their policies can be amended or finalized.
The whole minimal manipulation thing is an easy workaround for me - yes, we are manipulating the adipose structures (which are normally used for protection, support, cushioning etc etc) but SVFC is not interested in the structure of the tissue, it's simply using the adipose structure as a source of stem cells and it's the stem cells themselves that need to be assessed against the minimally manipulated criteria.
Please challenge my thoughts if you want to...
Soon be $20 a share... LMAO
