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Cytori´s Technology- Celution, IP etc etc
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TOPIC: Are your fat cells a drug?

Are your fat cells a drug? 11 Apr 2015 12:18 #4159

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As most know- the answer to that question is yes-for the US and the US ONLY- in each and every case when SVF is derived manually from a patient or with any device which is NOT called Celution.
A lot of clinics dont want to know and are still acting like their nose is bleeding or simply do not care as long as the FDA is passive in its policy to require adherence to their guidelines.

Chris Centeno wrote a concise blog article on this subject which I recommend you read, so you understand the "fine" details a bit... :yep:



The major part of that article..

Processing to isolate non-adipocyte or non-structural components from adipose tissue (with or without subsequent cell culture or expansion) is generally considered more than minimal manipulation. This is because the connective tissue and structural components of the adipose tissue are entirely removed from the non-adipocyte or non-structural isolates, thereby altering the original relevant characteristics relating to the tissue’s utility for reconstruction, repair, or replacement.”

Still not clear? Try this paragraph:

Example A-1: Adipose tissue is recovered by tumescent liposuction. The adipose tissue undergoes processing or manipulation (e.g., enzymatic digestion, mechanical disruption, etc.) to isolate cellular components, commonly referred to as stromal vascular fraction, which is considered a potential source of adipose-derived stromal/stem cells for clinical therapeutic uses. This processing breaks down and eliminates the structural components that function to provide cushioning and support, thereby altering the original relevant characteristics of the HCT/P relating to its utility for reconstruction, repair, or replacement. Therefore, based on the definition of minimal manipulation for structural tissue, this processing would generally be considered more than minimal manipulation.”

I can just hear the peanut gallery now, shouting, “but wait, I’m still covered as a doctor under the same surgical procedure exemption (21 CFR 1271.15(b))! What does this mean? The FDA carves out an exemption from the drug regulations for doctors who minimally process tissue during the same surgical procedure.

How about this paragraph from the guidance:

In regard to HCT/Ps from adipose tissue, we generally consider the exception in 21 CFR 1271.15(b) to apply only if the HCT/P from adipose tissue is for autologous use, is removed and implanted within a single operation or in a limited number of predetermined operations in order to achieve the intended effect, and does not undergo processing steps beyond rinsing, cleansing, or sizing. Limited handling such as rinsing and cleansing to remove debris would allow the HCT/P from adipose tissue to retain the structural function, while other processing steps such as cell isolation, cell expansion, or enzymatic digestion generally would not

Enzymatic digestion is what’s needed to isolate fat stem, cells, hence the FDA says that this process is not covered under the same surgical procedure exemption. So that means that if the doctor isolates fat stem cells in his office, he/she is producing an unapproved drug.

I can hear the peanut gallery screaming, “But it’s still not a drug if it’s from the same patient!”. I hate to burst any bubbles or rain on the fat stem cell parade, but we have this example from the document:

Example A-2: Adipose tissue is recovered by tumescent liposuction. Stem cells from the lipoaspirate are then isolated. Cell isolation would typically cause the adipose tissue to no longer be “such HCT/P.” Thus, even if this processed HCT/P from adipose tissue is injected into the same patient from whom it was removed during the same surgical procedure, the establishment would generally not be considered to qualify for the exception 323 under 21 CFR 1271.15(b).”

The upshot? While bone marrow stem cells for same day stem cell procedures are not considered a drug, the FDA is taking aim at doctors using fat stem cells in their offices. Regrettably, the doctors and lab people teaching weekend stem cell courses to doctors often tell physicians that fat stem cell processing is just fine with FDA. The above documents show otherwise.


The full article you can read here : Are your far cells a drug?
The following user(s) said Thank You: d9dozrman

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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:

Are your fat cells a drug? 12 Apr 2015 11:38 #4160

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Fas,

As most know- the answer to that question is yes-for the US and the US ONLY- in each and every case when SVF is derived manually from a patient or with any device which is NOT called Celution.


It is very clear that all the existing adipose stem cell clinics are operating in violation of FDA rules. What is not clear to me is the second part of your statement regarding the Celution. If a clinic were able to purchase a Celution today (wasn't there one on Ebay from Todd Malan?) wouldn't it still not be able to operate without some sort of approved clinical trial(i.e. IDE)? This is where this gets murky.

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Are your fat cells a drug? 12 Apr 2015 12:29 #4162

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If a clinic were able to purchase a Celution today (wasn't there one on Ebay from Todd Malan?) wouldn't it still not be able to operate without some sort of approved clinical trial(i.e. IDE)? This is where this gets murky.


:grin: Yes- there was one at Ebay at several occasions and at very different prices....

But that stems from the days GE as distributor sold some as "laboratory equipment for research purposes ONLY".

Celution is not approved in the US for anything yet and requires an IDE and following PMA clinic approved by the FDA before it can treat anything. The PMA will only provide approval for that one indication only- not general.

Anyway- but I am correct in writing that "the cells coming out of Celution for a therapy" are NOT a drug- key is Celution at present can only be used for research in animals and FDA approved clinical trials in humans. Thats it, any other use would be unlawful.

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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:
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