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TOPIC: FDA: "More Than Minimally Manipulated"

FDA: "More Than Minimally Manipulated" 22 Dec 2014 13:30 #2970

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The FDA today released their current thoughts on whether the extraction of ADRCs requires a biologic license, as a prelude to new guidelines to be introduced next year. Stem Cell Clinics around the country are NOT going to like this because if the FDA enforces these guidelines, they will all be shut down. Here is an excerpt:

"Example 10-1: Original relevant characteristics of adipose tissue, a structural tissue, to pad and cushion against shocks generally include its bulk and lipid storage capacity. A manufacturer recovers adipose tissue by tumescent liposuction and processes the adipose tissue to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells. The HCT/P generally is considered more than minimally manipulated because the processing breaks down and eliminates the structural components that provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement."

SVF or ADRCs, derived from fat, will be reaffirmed by the FDA to be considered a drug requiring a biologic license. If enforced this will put all stem cell clinics that use SVF, out of business until an approved FDA device / therapy is available. This obviously helps the first player to this market which should be Cytori. One big question I have is whether off label use of an approved Celution will be allowed in the same manner as off label use of prescription drugs. The cat is already out of the bag yet the FDA seems intent on putting it back in the bag. This is excellent news for Cytori and Okyanos, IMHO. I don't think I need to explain why.

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FDA: "More Than Minimally Manipulated" 22 Dec 2014 16:03 #2971

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Yes- I do hope folks will understand.

This will probably provide a monopolistic environment for a few years in the US and hopefully the trend elsewhere on the globe will be as such that it reaches US media also, so they know what they are "missing". :yawn:

This all is subject to real "law enforcement" by the FDA or US doctors becoming "law obiding citizens". I think it has to be the latter. :yep:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

FDA: "More Than Minimally Manipulated" 22 Dec 2014 16:05 #2972

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Off label uses of a therapeutic is not allowed by the FDA. Certainly, people can pay their own way to be treated in these unapproved procedures. But, once the treatment is caught, the consequence is predictable.

Okyanos is operating outside of the US, so the new FDA regs would have no impact on them and CYTX.

I think CYTX's new game plan is in the right direction both in the US and off shore.

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