http://www.hairlosshelp.com/hair_clonin ... henik3.cfm
HAIRLOSSHELP: Is there any concern of skin cancers forming from the introduction of these cells?
DR WASHENIK: The concern of skin cancers with tissue engineering comes from concerns about some of those regulatory factors. For example we know that Sonic Hedgehog expression, which is known to be important in hair follicles, is also known to be a factor in people who have a disease called Basal cell nevus syndrome. These people grow countless numbers of basal cell skin cancers and Sonic Hedgehog has been implicated in that. And then there is work being done with the Wnt pathway with Beta-catenin and Lef-1 where they show if you over express the regulatory proteins you can gets these growths called Pilomatricomas. So it would be problematic if you have to introduce regulatory molecules from outside the body because its very hard to deliver them at the right time and in the right amounts when the cells need them. That’s why the work that has been done with tissue engineered hair growth based on cellular technology assumes that you wont have to deliver those growth factors and the body will produce them in the correct fashion so there won’t be any of these concerns. How you pull that off in terms of how you package those cells may be very dependent on how those cells interact in culture with one another before you even put them into the skin.
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HAIRLOSSHELP: Is that 5 years to commercial release?
DR WASHENIK: I think it’s realistic that 5 years from the opening of ARI we will have a commercially available product or a technology that’s in the latter stages of development. Now bear in mind that research takes its own course so things may change. But let me explain why I say 5 years. If you take something like a brand new technology, it would likely take 3 years to get through the regulatory process. That’s why I think it’s reasonable, because I’m being conservative. Right now no researcher knows the exact regulatory steps the FDA will place on this procedure because it is brand new. There are not a lot of bioengineered organs you can point to to know exactly what the FDA will require. So I think 3 years is a reasonable period for regulatory pathway trials. That then means I am giving 2 years to get the actual package of technology together for submission to the FDA or appropriate regulatory authority so we can go forward with the clinical trials.