Intellicell Biosciences Inc (fka SVFC)

[Cosmic Chi]

Happy Monday morning all – the start of February, who knows what great things will happen this month…

So I was thinking over the weekend and got to wondering about the first IND with Andrews for OA knees and I remember reading a post stating that Andrews was working with the FDA on this IND and that the results should be out around March.

This got me thinking about the new FDA ‘guidelines’ which were published in December 2014 stating that any adipose tissue structures must not be altered if they were to be considered as ‘minimally manipulated’. This is bizarre as SVFC does not re-introduce the adipose tissues back into the body, just the SVF cells.

I wonder if Andrews could be using this IND to influence the FDA into amending the wording in this guidance document to reflect that only the products re-introduced to the body would need to be minimally manipulated. If this were the case, it would allow the SVFC preparation method to meet the requirements of ‘minimal manipulation’.

I can’t understand why the FDA has used this terminology as it seems crazy to think that a structure that is going to be deliberately broken down and then thrown away needs to undergo minimal manipulation – I do wonder if there is some lobbying going on behind the scenes by the big pharmas.

Thoughts…