Intellicell Biosciences Inc (fka SVFC)

[Cosmic Chi]

My background is as a military paramedic so my knowledge of the FDA is limited but I do have a few thoughts…

The easy one – ALS or Lou Gehrig’s disease is a progressively debilitating neurological condition with no known cure. The FDA could quite easily approve a study/treatment protocol using Intellicell’s extraction process to treat ALS patients as it could fall under either an Emergency Use IND or a Treatment IND. Obviously any data generated during these activities could be used towards an overall evidence case for the safety and efficacy of the extraction process.

We know that Dr Manuel Trujillo (psychiatrist) is interested in this work and has already been working with Intellicell to look at potential clinical research studies (some reports also say that his sister has ALS) and there are also some slides published of a presentation that Dr Victor delivered at the 2014 Marcum Conference which showed QEEG scans pre and post treatment with stem cells (don’t know if it was SVFCs but I personally think not):

https://www.scribd.com/doc/227057734/Intellicell-Biosciences-Marcum-Conference-PDF

As I’m not that knowledgeable on FDA processes and regulations I don’t know what other aspects of FDA regulations may be met with a study into SVFC treatment of ALS.

As regards the safety side of things, there may be sufficient evidence from all of the treatments that have been carried out to support a safety claim that the FDA require (provided of course sufficient notes have been kept) without going back to animal studies. The only published issues seem to be in relation to local infections at wound sites…

You also raise an interesting point here, I’ve been thinking of Andrews working with the FDA, what if we throw Hill and Inventiv into the pot as well – FDA working with a world renowned orthopaedic/sports injuries guru plus a well thought of clinical research organisation plus that CROs ex-CEO; that would be a powerful combination IMO, one that the FDA would might be happy to work with (as they’re still on the learning curve in relation to stem cell therapies and biologics).

I personally think this is where we are at the moment and that there’s a collaborative effort going on – the out of the blue comment about the Hielscher flask suggest a hiccup but one which has been overcome, and a hiccup suggests work in progress.

From a European Patent perspective, the amended reports were filed in January so there could be an outcome in the near future (perhaps even mentioned in the now overdue 10K) but you’re right, this doesn’t stop Intellicell from acting on an international front and the little trip to the UAE could be the next move in the game.

If we do have to go down the new drug route without any FDA exemptions, there is nothing wrong with starting trials in Europe as it is quicker than the US (I’m following another biotech which is doing just that).

Corporate structure has been talked about by plenty of people, I’m not sure what will happen; if financing is on board, those decisions have probably been made already…

Just got to wait for the 10K and see what happens from there but I do believe that this is still a potentially game changing technology however badly the company has been mismanaged…