Saturday, 04 February 2012 16:34

The versatility of the Celution Extraction Device

There seem to be several misconceptions or maybe just different opinions about the ability for Cytori to protect the IP, which went into the designing- and engineering of the Celution range of products. Thereto different opinions about the technical superiority of the same system. I do not think the following write-up will eliminate differences of opinion, but provides sufficient additional information to provide a clearer picture.

Presently we have the Celution 700 system designed specially for the US- this in respect of the clarity to convey the individual "approved" predicate devices- is awaiting FDA approval still.

The FDA 510K application was filed several times- the approval denied as many times, but those decisions were appealed and are going in front of a court in April 2012, which is NOT FDA prejudiced.

UPDATE:

Recently in early April 2013- the US court presiding over the case, decided that they are not in a position to challenge a "competent authority as the FDA". So- the FDA will NOT let any extraction device get into the hands of "the practice of medicine"

Celution 800, with CE mark from the EMEA in Europe, and which "can be" marketed there with additional claims on breast augmentation, breast reconstruction after lumpectomy AND fistulas after Crohn´s disease, together with numerous other claims since Juli 2012, Celution 900, the same CE mark, but as a component of the StemSource banking system and of course Celution One - the Olympus designed and manufactured system in Nagano, Japan with all the "bells and whistles", which finally (one year after filing for approval) gained CE status WITH the additional claims on therapeutic applications as Celution 800 had already achieved i.e the machines are "substancially equal" from a regulatory- and functional perspective. But- of course Celution One is much more efficient in respect of processing time and output yields of cells. 

 

Some claim you can put fat in a household centrifuge and get cells from the bottom part by celution-inputlooking at the colour of the resulting debris (dont put your damp clothes in, while trying out!), others think, the Celution 800 is the high tech device compared to which competing equipment like the TSG-1200 from TissueGenesis is the household centrifuge. I prefer to stay neutral here and will wait for the future to tell me what is true. What wecelution-output do have is claims from the company in respect of the virtues of Celution. (Pictures- left Celution Input- to the right-  Celution Output)

 

These sparse statements relate to 1. The digestive lipase used to separate the cells from the adipose tissue in which they are embedded. In the Q1 2009 CC in May Calhoun (CEO) described this as a product which has been developed over years with an unnamed large pharmaceutical company and no comparable product is on the market.

You can re-visit his statement in the short (<2 min) audio recording below-

Nowadays we know who that partner is- Roche Pharma and even know its name since it was mentioned in a patent filing- main thing though- its exclusively marketed by Cytori- thereto the best and provides a competitive advantage in respect of getting out clinical grade cells.

And 2. An explanation by Marc Hedrick, President, in the Q2 2009 CC, where he described the versatility and flexability of the system by explaining this on a "working" example- the SUI pilot presently going on in Japan. In the mp3 recording, you can hear the 5.14 Min explanation by Hedrick based on a question by a long time Cytori advocate from Oppenheimer. This audio is HIGHLY RECOMMENDED to get an understanding of the Celution process and versatility of the system.

The software or different "gentle" gyrations appear to be key, most likely in order to get the cells in hydrophobic stages, which appear to be very important on a molecular level and which is also confirmed by Hedrick in his statement-

The core Celution technology can yield different formulations customized for different particular diseases. He described that these different outputs are achieved by software and handling cells differently AFTER processing.

The technology issue inspired Doctor_of_Value- Yahoo user and highly respected author on virtually all themes surrounding Cytori to do some "digging" and who came up with this excellent post on Celution and the "Centrifuge" issue-

ADRCs are held throughout the fat cells by a chemical bond. The only known way to separate ADRCs from the fat without destroying them is to use an enzyme to dissolve the matrix strands. The Celution system does have a centrifuge as part of the process, but it spins at a relatively low RPM. The final product from Celution is pure ADRCs.

All other companies and plastic surgeons that use centrifuges or ultrasound to force cells out of the adipose tissue destroy the cells in the process. The RPMs required to overcome the chemical bonds are simply too high to avoid destruction of the cells. Most of the final product is made up of red and white blood cells and obliterated stem cells. This junk can be added back to cleansed fat for an augmentation or breast reconstruction, but there is no therapeutic benefit. I am sorry to say, but Suzanne Somers got duped. She will lose at least 30% of the fat that was injected.

Cytori has patents covering all methods of separating ADRCs from adipose tissue. Separating red and white blood cells from fat is not a violation of the patents.

This is what distinguishes Cytori from all other companies. They have a virtual monopoly on obtaining clinical grade ADRCs. Their ‘484 patent has already been challenged for validity due to its breadth and has been upheld by an appellate level of the US Patent Office without any modification. Investigator initiated trials are going on all over the world for applications in treating all sorts of ischemic caused diseases. The results are nothing short of amazing and are the foundation for all partnership discussions. Our own trials have shown statistically significant and superior results to the standard of care for CMI and AMI.

 

The final validity of theadrcs above will be outcomes of clinical trials of course, in which respect Cytori already has delivered compelling evidence and which I am confident they will continue to do so. Everything works simply, what they have touched sofar. The other aspect is patents and IP, which one can check on a current -todays- basis. I will do so in the next article, where I will research TissueGenesis- already known to me for the past four-five years. Other Korean developers and IntelliCell etc will not be covered since I believe those to be scam companies.

So, commercial ADRC´s -see picture on the left, will most likely only come out of Celution for the foreseeable future- at least in developed countries that is.

 

And the way that will look on the machine itself was nicely described in Susan Begley´s WIRED article, which ended with these lines-

There is one other key feature that the next generation Celution machine shares with a photocopier, as Calhoun demonstrates. Just as the latter has a touch.screen control panel that displays options (paper size, number of copies, magnification), so does the Celution, only here, the options are organs. See? There's a picture of a breast, a heart, a disc in the back,"he says. "You push that and the machine loads different software, which adds the right drugs, reagents, or other biochemicals to the liposuctioned fat cells. He envisions an iPhone like business model, with individual doctors doing apps to repair different organs with the perfect slurry of adipose regenerative cells. If il works, the breasts on his laptop will have plenty of company.

Last modified on Monday, 22 February 2016 05:05

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