You’re right to give a balanced point of view but I’d like to challenge you on some of your comments Gem…
Firstly, this is the pre-IND, which in my head, is all about SVF preparation, protocols, quality control and patient safety concerns before we even look at any kind of illness, injury or medical condition.
In order to begin any kind of study, there would need to be a way for them to isolate the cells so there’s probably been some sort of lab set up which will require FDA inspection and assessment of protocols and practices etc.
Perhaps the lab techs at the Andrews Institute have found a way to enhance the yield (remember the Roche subsidiary that confirmed the numbers of cells so the existing process seems to work already) by suggesting the new reactor (the release in January suggested that Hielscher had ‘developed’ – past tense, the reactor) and perhaps it’s already in use – Intellicell aren’t known for their timely press releases so there’s a strong possibility that it’s already in service…
The flip side is that the reactor might offer a slightly different way of preparing the SVFs which is more favourable for the FDA – remember that they’re still learning about the use of biologics and seem to be writing the manual as they go along (this also makes it easier for Andrews to influence any changes if he feels that it’s appropriate – it would take a brave FDA person to challenge Andrews I think).
The anecdotal evidence from all of the other one-off trials suggests that the process works, there are sufficient cells and that patient recovery is enhanced through using cells prepared by the Intellicell process
Legal issues – possibly I don’t know enough to comment…
I’m not entirely sure we’ll see too much in the annual report due out shortly but I think this study is way bigger than just Intellicell, this has the ability to impact every other research study using stem cells as if proved successful, it could become the preferred method of stem cell production because of the benefits of producing in this way…
