Now how long until it comes to market.
“Spheroids” - sounds like Dr Angela Christiano’s approach.
[quote][postedby]Originally Posted by News[/postedby]
“Spheroids” - sounds like Dr Angela Christiano’s approach.[/quote]
Christiano and Jahoda.
And it appears that the Chinese may have solved the
trichogenicity problem. Not sure but that is what it looks like.
‘They then implanted these DP “spheroids” into nude mice’
It’s mice again, so we don’t know if this is significant or not yet…
[quote][postedby]Originally Posted by Skywalker[/postedby]
‘They then implanted these DP “spheroids” into nude mice’
It’s mice again, so we don’t know if this is significant or not yet…[/quote]
Yea but the DP cells are human. This is not a routine mouse study.
A report about positive results in mice doesn’t mean they also tried it in humans but it didn’t work. It just means that they haven’t tried it in humans YET. They are using mice because they haven’t yet received permission to implant these spheroids in humans. Getting permission to do something like that is VERY complicated, expensive and can take a while – and yes, even when the DP spheroids come from the same person they’re re-implanting them into.
The rules for testing biologics like this (cell therapies) were recently changed and made more restrictive. Now even if you’re re-implanting a person’s own cells, if you do anything to manipulate or change those cells before re-implanting them, in almost any way (and obviously, here they are manipulating the cells by making spheroids) then FDA approval must be sought.
[quote][postedby]Originally Posted by roger_that[/postedby]
A report about positive results in mice doesn’t mean they also tried it in humans but it didn’t work. It just means that they haven’t tried it in humans YET. They are using mice because they haven’t yet received permission to implant these spheroids in humans. Getting permission to do something like that is VERY complicated, expensive and can take a while – and yes, even when the DP spheroids come from the same person they’re re-implanting them into.
The rules for testing biologics like this (cell therapies) were recently changed and made more restrictive. Now even if you’re re-implanting a person’s own cells, if you do anything to manipulate or change those cells before re-implanting them, in almost any way (and obviously, here they are manipulating the cells by making spheroids) then FDA approval must be sought.[/quote]
If they bring it to market in the USA. I know that right now they’re talking about bringing it to market in China first and I think China’s
laws are less stringent so it would come to market in China quicker.
Do you think it’s an advance over how far Jahoda has gotten things?
Do you agree or disagree with me that the fact that he used human cells makes a human study seem VERY promising?
I think this is more of a function of Chinese manufacturing prowess. When 2 biotech researchers in western countries see a problem, they think of only a biotech solution, whereas when biotech researchers in China see a problem, they think in terms of both biotech answers and a manufacturing solution – what can be built to make the process better AND sold all over the world.
Probably in terms of the lab work alone, the Christiano/Jahoda team and the Chinese team are at about the same point, but this might give the Chinese group the edge.
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