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April 13 2016 is the date of the public hearing, which is of extreme importance for the future of Cytori as a Company. It will likely also determine whether Cytori is "partnerable" or not.
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TOPIC: New category on FDA legislation

New category on FDA legislation 17 Feb 2016 05:00 #6409

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I created a new category for the Lodge with the title -FDA Regulation of SVF.

I presume all of you, who has been reading here, know what that means. :whistle:

If you do not- no sweat- there will be plenty of reading material following in the next couple of months and in my view (besides solving the cash issue) this event or the decision coming out of the process will be of utmost importance to the future of Cytori as a Company.

In my view they could make it as a stand-alone Company with a minimal staff level- but apparently they have chosen not to follow that path and continue to operate with a heavy loaded organisation with heaps of overhead and highly paid top personnel... :whistle: i.e. money is required to pay for that burden.

That means partners and in the US only partners can be had with the FDA showing some muscle in the forthcoming months and regulation settled in a favorable way.

Therefore this new category- yes- its make or break time... :cool:

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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:

New category on FDA legislation 17 Feb 2016 05:24 #6411

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On April 13 2016- a hearing will be held "relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products"

Rightly so - Cytori is a "by-stander" at this meeting, since they surely do NOT object to any of the proposals made.. :yawn:

All persons and organisations who registered for the meeting at the White Oak Campus in Maryland have each 3 minutes to speak up their mind... :whistle:

The listing of speakers is quite interesting...have a look...


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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:

New category on FDA legislation 17 Feb 2016 06:43 #6412

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As a "not so healthy person" in the past, who has been "blessed with MI and cancer issues" I have always thought stem cells would help me get control over my own health destiny in the future. I think that was wrong- it just is a part of a substantial set of tools available to any person to get control over his health destiny.

From that perspective, I am not so hot any longer to give easy access to SVF without controls to any doctor, especially since in the US the profession appears extremely profit motivated, different from what I know to be the case in Europe and as a result abuse and unwanted outcomes are very likely. So- my heart tends to be both with the best interest of patients, but also with my financial interests in Cytori which employees were paramount in the discovery and development of SVF/ADRCs technology.

What Matt Feshbach said in the interview about regulation by the FDA kind of makes sense to me as an intermediate position- but than applied in 5-10 years or so after Cytori has had the benefit of a virtual monopoly in the US for those years.... :grin: :whistle:

Matt´s view:

Whether it is right or wrong, it is very clear that the FDA is up-regulating stem cell therapy. About six months ago, the associated press wrote an article calling stem cell therapy the “Wild West.”

There are networks of stem cell clinics that use inferior technology and are clearly non-compliant to FDA standards, so now the FDA has begun to up-regulate against them. I think unfortunate side effect of this is that the FDA has decided to define our own biology as a “drug” that needs approval and that is, I think, too complex.

I think that they should have some pathway for legitimate companies to show that they can provide a safe, effective product to patients, and then let doctors practice medicine. However, to say, “You have to complete Phase III trials even if you have successfully and safely used this product in Europe. You have to start over in the United States and prove that these cells do what’ has been documented in 65,000 papers.” That seems inappropriate

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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:

New category on FDA legislation 17 Feb 2016 11:16 #6418

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Just to keep all of us on the same page

Stromal Vascular Fraction (SVF) is a component of the lipoaspirate obtained from liposuction of excess adipose tissue. Lipoaspirate, the waste product of liposuction (cosmetic surgery), contains a large population of stem cells called adipose derived stem cells (ADSCs), which share a number of similarities with bone marrow stem cells, including the capacity for multilineage differentiation.

Fas,

I too think that these cells should be regulated. In my thinking there is enough research to show that they can be used "safely". The efficacy of the therapies and their ability to help patients is what has to be proven. There needs to be a "breakthrough" indication. The move to diseases such as scleroderma, a horrible affliction with few treatment options, seems to me to be a good strategy for Cytori.

I totally agree with your assessment that ADRC's are a tool that can be an important part of medicine's future. The structure of the FDA's approval process is timely and expensive. Small companies in the stem cell space such as Cytori are not able to navigate the costs effectively. My only hope is that the fastidiousness of the FDA process is in the best interest of the afflicted! I do believe the science will eventually prevail and that regenerative medicine will be an important part of health care in the future. Whether or not the current structure of the regenerative medicine community is able to survive long enough to become viable is a question that only time will answer.
The following user(s) said Thank You: mtpinman, d9dozrman, cytxer

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New category on FDA legislation 17 Feb 2016 12:43 #6419

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What I don't get at all is that FDA according to Marc has been very involved in meetings on BARDA project for burns. they have supposedly set the protocol with Cytori. If they set the protocol and have been involved in the process every step of the way, it escapes me that they would not understand the workings of Cytori and the safety etc. They were also involved in discontinuation of cardiac study after stroke. They were pleased with the steps that Cytori took so we were told and were satisfied that "stroke" was a result of the catheter being moved to direct cells as opposed to safety of stem cells. We have also been told that FDA was involved in process of development of the software for Cellution 2 which is now incorporated into Cellution 1 and has the ability to track the patients stem cells to be sure they are used for the applications for which they were drawn and not other applications on the whim of a Dr. It is my understanding that they want Cytori to sell the finished product and not the machines specifically for this reason and for regulatory control. When it comes to the Wild Wild West, that can hardly refer to the responsible manner in which Cytori has been operating. Who knows what is fact or what is fiction but I hope that following the rules will pay off for Cytori before the money runs out.

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New category on FDA legislation 17 Feb 2016 13:52 #6420

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Just to keep all of us on the same page

Stromal Vascular Fraction (SVF) is a component of the lipoaspirate obtained from liposuction of excess adipose tissue. Lipoaspirate, the waste product of liposuction (cosmetic surgery), contains a large population of stem cells called adipose derived stem cells (ADSCs), which share a number of similarities with bone marrow stem cells, including the capacity for multilineage differentiation.

Fas,

I too think that these cells should be regulated. In my thinking there is enough research to show that they can be used "safely". The efficacy of the therapies and their ability to help patients is what has to be proven. There needs to be a "breakthrough" indication. The move to diseases such as scleroderma, a horrible affliction with few treatment options, seems to me to be a good strategy for Cytori.

I totally agree with your assessment that ADRC's are a tool that can be an important part of medicine's future. The structure of the FDA's approval process is timely and expensive. Small companies in the stem cell space such as Cytori are not able to navigate the costs effectively. My only hope is that the fastidiousness of the FDA process is in the best interest of the afflicted! I do believe the science will eventually prevail and that regenerative medicine will be an important part of health care in the future. Whether or not the current structure of the regenerative medicine community is able to survive long enough to become viable is a question that only time will answer.

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