Welcome, Guest
Username: Password: Remember me
Adult Stem Cell News and Developments other than Cytori
  • Page:
  • 1

TOPIC: The Cell Surgical Network

The Cell Surgical Network 01 Oct 2013 15:52 #913

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
This post appeared at LinkedIn in the Cell Therapy group, that I feel you all should be aware of too.
Two days training courses to get medical docters introduced to cell therapy and maybe being able to trat patients????

The Cell Surgical Network will be hosting their next AccreditationTraining Course this October 29 and 30, 2013 in Rancho Mirage, CA. To find out more please email me This email address is being protected from spambots. You need JavaScript enabled to view it.
The rise of Regenerative Medicine may well be one of the great technological advances of the turn of the 21st Century. In the cyber age, cell medicine information spreads faster than genuine knowledge and expectations for medical cures outpace current technology. Most of the resources devoted to advancing regenerative medicine have been channeled from government grants and pharmaceutical company research into basic laboratory work. Although basic laboratory science research is vital, one must consider the role of translational research in making progress in bringing technology from the “bench to the bedside.” Working in this manner, many of the great historical advances in medicine were obtained by thoughtful and courageous clinicians.

Clinical knowledge of some of the practical applications of stem cell treatments have come mostly from international sources and the United States is severely lagging. At this time in the United States, most of the clinical trial work is designed to evaluate stem cells as a drug since the studies are designed by an industry whose model is to market something in a bottle to the masses. Hucksters and offshore enterprises of dubious quality have exploited this clinical vacuum. But there is another way.

Enormous quantities of mesenchymal stem cells in a rich soup of growth factors have been serendipitously identified in human fat as “stromal vascular fraction (SVF).” This rich storehouse of autologous adult mesenchymal regenerative cells can be harnessed and deployed through a surgical procedure that is a type of “fat transfer.” American physicians must embrace the concept that a person’s own cells from their fat are not an investigational biologic but instead, they are a surgical tool in the physician’s armamentarium to fight disease. This ability to use one’s own cells to treat degenerative disease without pharmaceuticals is what we have termed “The Stem Cell Revolution.”™ As physicians and scientists, we must apply academic rigor to the evaluation of safety and efficacy of our techniques. We must develop and hone surgical procedures within our “scope of practice” to exploit the fascinating regenerative properties of SVF and advance our knowledge of cellular healing. Professional research networks can catalyze this process under Institutional Review Board (IRB) approved protocols by standardizing techniques and providing a platform for sharing data efficiently.

To find out more please email This email address is being protected from spambots. You need JavaScript enabled to view it. or call 1-800-231-0407
The following user(s) said Thank You: Joncon63, joeycav11, d9dozrman

Please Log in or Create an account to join the conversation.

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:

The Cell Surgical Network 01 Oct 2013 16:05 #914

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
I will post the most relevant posts from the discussion here and am curious about your comments:

Lee Buckler: Chris. By all reports your network is growing very quickly which must be very exciting for you. Your post is interesting and I'd love to learn more. In this training course do you teach physicians how to use SVF to address the conditions listed on your site at www.stemcellrevolution.com/currently-studying/ ?

Chris Centeno: Chris, the FDA has declared in writing multiple times that SVF, even if made at the bedside, is a new drug that needs approval. They have visited and shut down several physicians who are using SVF. While I personally think their classification of SVF as a drug when used by a physician in an autologous fashion has no basis in law nor public health imperative, how are you dealing with this regulatory conundrum?

Chris Lindholm: Our surgical procedure using a closed system to keep sterility intact from the time we harvest the adipose tissue, process the cells and filter out the enzyme, then deploy the cells back into the patient. Our closed system goes in line with the FDA Title 21 Chapter 1 sub chapter L part 1271 human cells, tissues, and cellular and tissue-based products covering the prevention of the introduction, transmission, or spread of communicable diseases. The bad thing with the FDA is that they are a large government entity and can do whatever they want, we believe we are following the standards they put in place even though they do not regulate surgical procedures. I just finished building our database to track the progress of our patients with their conditions and safety studies with our AE/SAE questionnaires as well. Hopefully we will be able to present this data we collect from our procedure to show and maybe change the view of the FDA.

Chris Centeno: Chris, regrettably what you are doing is what the FDA considers more than "minimal manipulation" whether in a closed system, at the bedside/same surgical procedure, or with or without data tracking. See:

app.box.com/s/v8du7czi944s3xlblr5g
www.cosmeticsurg.net/blog/2012/01/11/fda-stem-cells-from-your-own-fat-are-a-drug/

In both of these instances, the physicians were proposing the same thing as what you're doing. There are many more FDA letters to physicians out there, some documenting visits to clinics.

I know there is an urban myth among SVF docs that if you do all of this at the bedside (in the same surgical procedure) than the practice of medicine trumps the FDA regulations, and purely from a legal standpoint I feel that's correct. However, the FDA doesn't agree based on their written positions, actions, and legal documents in everything from Regenerative to Cytori. In the Cytori instance, they had much more extensive lab data showing that there was no substantial enzyme that went back into the patient. The FDA still required an IDE/PMA (prospective double blind, free of charge, clinical trials) for their device approval.

Does this make any common sense? No. Does it make any public health sense? No. However, you need to make sure the docs you teach put away legal fund pennies for a rainy day. They also need to be informed that they are at legal risk using adipose SVF, whereas other same day tissues are for now not being regulated as drugs (bone marrow aspirate, platelet rich plasma).

Fas Kuiters: Richard- the lecture of Dr. Berman indicates that he uses devices of South Korean Medi-Khan- www.medikanint.com/index.html
I know the Lipokit has 510K approval. Do not know about the other two pieces- 416D and Celltibator

Chris Centeno: We looked into these awhile back and our counsel told us that they were either research use only or they had used the wrong predicate device for their 510k and to steer clear...

Lee Buckler: Chris. L -- thank you for your transparency and willingness to engage with us here. I'm not as sure as Chris C. that the FDA has been quite as clear as he as suggests as to classifying all "SVF" as requiring an IND but there does appear to be a clear trend that they will consistently default to considering any digestion of adipose tissue using enzyme as constituting more-than-minimal-manipulation' until if and when someone shows that doing so does not "alter the original, relevant characteristics of the adipose tissue's utility for reconstruction, repair or replacement."

Frankly while I'm curious about the process and technologies your employ what is more concerning to me is that you are encouraging plastic surgeons to treat a host of diseases and conditions well outside their area of medical expertise. This goes to the 'homologous' use nature of what you are doing. It is very difficult for me to imagine any legal counsel advising you given the FDA's past actions that they will consider using fat-derived cells to treat multiple sclerosis as a homologous use of those cells.

I don't point this out to be argumentative, critical or judgmental in any way of what you are doing or the quality of the medical care or ethics of your physicians. I simply mean to point out my very strong belief that the FDA will someday soon let you know that they disagree with what you and your networks' physicians are doing in this regard.

Chris Centeno: Alexey, this is very common in California. Korean manufacturers (there are several) have entered the US market by usually characterizing what they're selling as "FDA Approved" when in fact they usually register it as a "research only" device. The docs tend to believe this means that it's 510K approved for this purpose, but when you have a regulatory attorney dig under the covers at any depth, it's not 510k cleared for that purpose as no predicate device exists. This is the issue Cytori ran into, where their device was using the Harvest BMAC system as a predicate (not an accurate predicate). So you're right, there is no adipose SVF system on the US market that is "FDA Approved" at this point.


This is a bit out of order since I have omitted some stuff, but represents the key points... :cool:
The following user(s) said Thank You: Joncon63, d9dozrman

Please Log in or Create an account to join the conversation.

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:

The Cell Surgical Network 01 Oct 2013 19:55 #915

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2823
  • Thank you received: 202
I wonder what kind of numbers the Cell Surgical Network attracts ?

As for the FDA and utter confusion as to what may or may not be allowable is no surprise. Of course confusion can be used as ones friend if one wanted to, I suppose. Maybe CC can leave CYTX and join many other pompous idiots at the FDA...LOL ! :bash: :grin:

I also think these discussions show how early this field is with legal wrangling, translational studies still the main focus, and Doc's questioning Doc's who should do what ? The sales ramp continues at a grade even a patient with CMI could handle...remember, the last conference Saad spoke at he reference Billions ( or at least a billion for CMI) and we are waiting and hoping for 12 million this year.

Please Log in or Create an account to join the conversation.

The Cell Surgical Network 02 Oct 2013 12:02 #916

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115
Hedge-

Heaps of things come to mind if you read this-

- if you look at the website Cell Surgical it is clear at first sight that we are not the only ones convinced at the enormous size of the app platform.
- this is business- the FDA is swimming with their rules, but it is clear once they get involved that they will close down the practices. Since low fines are involved these guys just think its worthwhile to take the chance before they are stopped.
- the are working with "research" equipment- just like Todd Malan did with his Celution which he bought as a laboratory piece of equipment
Malan is now in this group and offered his Celution for sale at Ebay
- my general feel is- part of society is sick and simply "money greedy"- even in the medical profession a buck is better than being ethical.

Please Log in or Create an account to join the conversation.

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:

The Cell Surgical Network 02 Oct 2013 16:59 #917

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2823
  • Thank you received: 202
Got some time to poke around the Cell Surgical site...very user friendly.

Looks like they have 44 Doc's and are growing....curious what type of patient attraction they will get and will they drain efforts to find patients for FDA studies.

Maybe they dont last but they appear to have done far more in a short period of time than the SanDiego bozos !!! Of course I bet they dont have a clown car for their meetings...LOL :evil:

Please Log in or Create an account to join the conversation.

The Cell Surgical Network 03 Oct 2013 07:28 #918

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115

Maybe they dont last but they appear to have done far more in a short period of time than the SanDiego bozos !!! Of course I bet they dont have a clown car for their meetings...LOL


Hedge- there are now > 25.000 scientific articles on mesenchymal cells- I estimate about 500 studies on ADRCs. Thereto in the US there is NO approved device for automated extraction of ADRCs and the manual procedure of extraction is deemed to be a DRUG (IND) by the FDA.

It took Cytori 8 years of research and clinical data to get approval for Celution to treat patients intravenous and intravascular and those docters think they can overrule anything - to me- simply out of greed, with little to do of being Samaritans. Al Capone got things established pretty fast in Chicago in his days- however it does not mean he was doing the right things.

Please Log in or Create an account to join the conversation.

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:

The Cell Surgical Network 03 Oct 2013 09:14 #919

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2823
  • Thank you received: 202
A large brush can be used when considering greed and the large option awards at Cytori over the years for failing at stated goals and announcements of pending partnerships.

What did you think about Doc's, such as the ones at cell surgical, effecting the pool of study canadates for FDA trials ?

Please Log in or Create an account to join the conversation.

The Cell Surgical Network 04 Oct 2013 06:02 #920

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115

A large brush can be used when considering greed and the large option awards at Cytori over the years for failing at stated goals and announcements of pending partnerships.


I agree that the options are pretty greedy also, but the difference being that it is backed by legal decision making. The Cell Surgical network is void of any legality and abuses mazes in the regulatory system in the US (for as long as it lasts)

I do not think it takes a lot of patients away for clinical trials- most in the US are cardiac and thats certainly not something they are equipped for.

Please Log in or Create an account to join the conversation.

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:

The Cell Surgical Network 04 Oct 2013 11:46 #922

  • rongside
  • rongside's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 387
  • Thank you received: 196
Fas - as you mentioned, the number of articles about mesenchymal stem cells shows the degree of interest in their treatment potential. As for the CSN doctors they are potential Celution adopters. They are believers in ADRC and will eventually have no option but to accept the only game in town. The FDA is clear that your own cells are a drug and will close down all operators who try the 510k "practice of medicine" route.

We are the only game in town. :woohoo:

Perhaps CYTX marketing should send an information booklet to these CSN doctors informing them of the FDA's past actions against other doctors and companies ........ along with a Celution booklet listing positive trial data and potential translational trials that they could participate in. :cool: :evil:
The following user(s) said Thank You: keysman

Please Log in or Create an account to join the conversation.

The Cell Surgical Network 05 Oct 2013 07:17 #924

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3336
  • Thank you received: 1115

Perhaps CYTX marketing should send an information booklet to these CSN doctors informing them of the FDA's past actions against other doctors and companies ........ along with a Celution booklet listing positive trial data and potential translational trials that they could participate in.


John- yes that would be nice, but they cannot. Key is the FDA- in Europe docters now can do all translational work they want. In Japan I presume it is similar if OK´d by the MLHW. In the US - without a 510K you cannot do anything. Chris Centeno mentioned he thought that using the Harvest machine as predicate device in the 510K application was wrong. Maybe he is right and Cytori should have used their own old approvals on Celase and fat extraction, blood processer etc which taken together is Celution. :whistle:

Please Log in or Create an account to join the conversation.

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:

The Cell Surgical Network 05 Oct 2013 10:53 #925

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2823
  • Thank you received: 202
The FDA will keep this out of US doctors hands for general practice for as long as possible !!! :evil:

No one wants a product that could kill the golden goose on so many drug prospects that would have to go thru the FDA. :evil:

The US drug/device approval process is big business. :evil:

Often best not to question who is behind the curtain really pulling the strings. :evil:

All IMHO of course !!! :yep:

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 0.111 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites