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TOPIC: Fat and Furious:Harnessing the Potential of SVF

Fat and Furious:Harnessing the Potential of SVF 11 Jan 2017 12:09 #8479

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The title is from a paper issued as paper in 2017 by South Dakota scientists. I just finished reading it and yes- I confirms pretty much my understanding of the history, cell composition and mechanisms of action of the different compartments together with issues surrounding SVF of obese folks. Funny enough- the authors "missed" the Cytori apps in their summary, since they searched on SVF and ASC´s, but not on ADRCs- the terminology used by Cytori.

Nonetheless- worth while sharing-

The Abstract-
Due to their capacity to self-renew, proliferate and generate multi-lineage cells, adult-derived stem cells offer great potential for use in regenerative therapies to stop and/or reverse degenerative diseases such as diabetes, heart failure, Alzheimer's disease and others. However, these subsets of cells can be isolated from different niches, each with differing potential for therapeutic applications. The stromal vascular fraction (SVF), a stem cell enriched and adipose-derived cell population, has garnered interest as a therapeutic in regenerative medicine due to its ability to secrete paracrine factors that accelerate endogenous repair, ease of accessibility and lack of identified major adverse effects. Thus, one can easily understand the rush to employ adipose-derived SVF to treat human disease. Perhaps faster than any other cell preparation, SVF is making its way to clinics worldwide, while critical preclinical research needed to establish SVF safety, efficacy and optimal, standardized clinical procedures are underway. Here, we will provide an overview of the current knowledge driving this phenomenon, its regulatory issues and existing studies, and propose potential unmapped applications. © Stem Cells Translational Medicine 2017

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Fat and Furious:Harnessing the Potential of SVF 11 Jan 2017 12:17 #8480

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The Conclusion reads as follows:

Conclusion:
Given its abundance and mixture of potentially therapeutic cells, the treatment of various diseases and conditions with SVF-derived cell therapies holds great clinical promise. Along with the combined efforts from IFATS and ISCTs, scientist and clinicians should further emphasize the difference between cells from the SVF of the adipose tissue and the adipose tissue-derived stem cells, the ASCs. Such difference may not only dictate different therapeutic rationales given the ever-expanding therapeutic properties of ASCs and the different cell components within the SVF, but also directly impacts therapy regulations, particularly in countries where the use of SVF could be placed under a less stringent regulation than ASCs or MSCs due to its autologous, point-of-care use. There is a great need to accelerate the knowledge of scientists and clinicians on SVF, specifically with respect to its composition, nomenclature and necessary studies. Many basic scientific questions remain to be addressed. Although the mechanisms through which SVF regenerates tissue remains inconclusive, the literature supports the contribution of paracrine effects, with crosstalk between SVF components and host leading to repair and healing. In this paradigm, differentiation may play a minor role. Future studies are needed to elucidate the mechanism(s) of action of SVF and their differentiation potential in vivo. The heterogeneity for different ASC and MSC preparations has been extensively discussed, including the work of Baer and colleagues highlighting ASC donor variability in forty-nine cellular surface markers in a comprehensive phenotyping study [155], and the work of Siegel and colleagues characterizing surface markers, proliferation capacity, and in vitro function from 53 different MSC preparations [156]. Further research needs to investigate donor variability in SVF preparations. Are there intrinsic differences in composition of SVF between donors? Studies that highlighted differences in specific subpopulations, like the inflammatory effects of obesity on macrophages [133] need to be expanded to other subpopulations in the SVF in order to understand how SVF composition differs in healthy versus disease states. These questions are particularly important to not only understand SVF biology, but to also reliably predict the therapeutic efficacy of SVF. Likewise, determining optimal dose/infusion schedules and the development of potency assays will help optimize the therapeutic potential of SVF. Encouraging studies mentioned here describing the isolation and characterization of SVF-derived HSCs, EPCs and pericytes attest to significant therapeutic promise. Hence, are we underestimating the therapeutic potential of SVF? Can the SVF be used as an alternative source of endothelial precursors, HSCs, M2 macrophages, regulatory T cells and pericytes? Classically, these cells have been found in the bone marrow or blood in low frequencies, limiting their clinical utility. Using the SVF as an abundant source for such therapeutic cells could have profound effects for a myriad of conditions and diseases (Fig. 1). Finally, adverse effects from SVF treatments offered in private, unregulated clinics often go unreported or are sometimes only found in the news. Results from completed phase 1 clinical trials (Table 1) indicate SVF treatment for osteoarthritis, SLE and fat graft—in which SVF is locally injected; indicate a safe profile, with no short time neoplasma, unwanted tissue differentiation or adverse effects. Given the autologous, noncultured nature proposed for SVF therapies, tracking SVF cells following infusion poses a significant challenge. Using a protocol for labeling SVF cells with CS-1000, a perfluorocarbon and 19F-rich agent, Rose and colleagues attempted to solve this problem by developing a labeling clinical protocol at the point-of-care [157]. However, the procedure required the use of red blood cell (RBC) lysis step and only 37% of the total SVF was labeled, with preferentially labeling of CD34+ cells over CD45+ cells. Current and future studies will elucidate the principal risks associated with SVF-based therapies, including where SVF-derived cells migrate and reside


The full paper below- since open access by the Stem Cells Translational Medicine


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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:

Fat and Furious:Harnessing the Potential of SVF 11 Jan 2017 12:51 #8481

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Thanks for sharing this Fas. What do you think of this statement:

The principal rationale behind the clinical use of SVF preparations relies on the existence of MSCs. However, it is known that SVF contains a diminutive percentage of MSCs, estimated at 2%–10% of the SVF [40]. Thus, clinical trials employing MSCs, regardless of tissue source, require their isolation and further in vitro expansion, as opposed to the use of freshly isolated SVF used in many clinics. In addition, the non-MSC component of the SVF contains populations of adipose, endothelial and hematopoietic stem/progenitor cells that have yet to be characterized. These cell types are functionally distinct from MSCs, but may share common markers such as CD34, which could encompass 63% of SVF cells, the majority of which are not MSCs [34]. These factors advance misperceptions surrounding composition of the SVF and further confound the field and the general public.


Surprised to see that blanket statement in this report.

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Fat and Furious:Harnessing the Potential of SVF 11 Jan 2017 13:45 #8482

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What do I hold of those particular statements (which were not in the abstract or conclusion)- nothing much really. I think you have to consider that most of knowledge comes from literature review and the accumulated knowledge of Fraser/Zhu et al does not compare to what these folks write and have as experience. Still the paper contains a lot of leg work and basic scientific stuff which is valuable for us to understand, since the experts- Cytori- simply do not volunteer to share scientific knowledge for competitive reasons.

Like most scientists who switch from bone marrow to fat they have to get used to the switch that you do NOT have to culture to get a therapeutic dose and therefore they come to these statements-

The principal rationale behind the clinical use of SVF preparations relies on the existence of MSCs.

That I think is not correct- the power of SVF is the cross talk and potency of fresh cells. For which reason you also do not need only MSCs (the 2-4 % -not 10%) but you do need the "Gemisch" :grin:
From my exchange with former Cytori scientists, I know all populations have been characterized and Cytori knows what each group does reasonably well.
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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:

Fat and Furious:Harnessing the Potential of SVF 11 Jan 2017 13:49 #8483

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FAS

Mesentery is now classified as an organ with important functions; autologous mesenteric cells play an important role here. I am sure we can find a lot of information and renewed interest along this line.

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Fat and Furious:Harnessing the Potential of SVF 11 Jan 2017 17:32 #8486

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You are right in that it is all about the "gemisch", and its freshness probably being a significant factor.

The potential utility of SVF reminds me of the utility of blood transfusions. It is essentially an autologous (subject to blood typing) life saving product for which there is NO manufactured substitute.

There has been a lot of discussion in other threads about the merits of allogeneic as opposed to autologous. I do not dispute that being correct from a commercial perspective as it provides a more marketable and defend-able product (IP).

However it is only material if there is no autologous alternative, and provided that the cost benefit relationship is such that it can compete with an autologous competitor.

It is true that we have seen a number of companies switching from autologous to allogeneic. Most of these companies were using BM which has no comparison to the richness of regenerative cells provided by ADRC (SVF). Their lack of success with past autologous trials and need for additional funding required a switch to the more conventional allogeneic approach favored by BP/BB for commercial purposes.

Their failure does not ensure the failure of ADRC. If anything the article in this thread provides further confirmation of the utility of ADRC (SVF). No doubt sometime in the future someone will be able to determine which specific (combination of) elements of the gemisch can provide a therapeutic result to a specific condition. In the meantime I believe that the FDA and patients will be happy enough if the "gemisch" works without having to wait for the manufacture of specific clearly defined/characterized sub-products to treat a serious condition such as scleroderma. Understanding "method of action" is great and I think that CYTX has a good understanding of the MOA for ADRC. Replication of this MOA given the complex make up of ADRC may not be so cheap as getting a LIPO and waiting for a few hours to get cured. Proof of efficacy is what it is all about. :yep:
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Fat and Furious:Harnessing the Potential of SVF 13 Jan 2017 11:12 #8500

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There has been a lot of discussion in other threads about the merits of allogeneic as opposed to autologous. I do not dispute that being correct from a commercial perspective as it provides a more marketable and defend-able product (IP).

However it is only material if there is no autologous alternative, and provided that the cost benefit relationship is such that it can compete with an autologous competitor.


I have to disagree with you, Rongside. If an allogeneic alternative to Cytori's scleroderma therapy were to get to the market at the same time as Cytori's autologous therapy, which do you think would gain more market share, all else being equal (i.e. safety, efficacy, cost)? In my view the answer is obvious... allogeneic - HANDS DOWN. Why would a doctor bother with an extra procedure and time involved along with the additional risks/discomfort to the patient? I also believe that, in the longer run, those allogeneic companies with cells that can be scaled to a over a million doses per donor have, not only a COGS advantage, but a regulatory advantage in that the FDA should have inherently fewer concerns regarding the variability of dose efficacy. This attribute is one of the main advantages of ATHX over MESO, TIG and other allogeneic companies. The notion that the ADRC gimisch is more efficacious than all other cells has not been proven yet and I doubt there is anything to it. ADRC's couldn't significantly beat the placebo in OA for Cytori, supposedly a low hanging fruit. I think Cytori will succeed on scleroderma based on what has been presented so far but in the long run the model is problematic, IMHO.

On another note, AST (asterias), an ESC company will be giving an update soon on its spinal cord injury trial. I expect a pop on good news and have positioned myself accordingly. Its an open label trial so the bar is low at this point and the CIRM will provide much plublicity, IMHO. Do your own DD.

WST

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Fat and Furious:Harnessing the Potential of SVF 14 Jan 2017 18:24 #8509

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WST, I do not dispute your arguments concerning autologous vs allogeneic, ALL THINGS BEING EQUAL.

However, all things in life are not equal.

My point was that it is not given that autologous will fail, just because some other companies changed their product development model.

The vital question I guess is....... does anyone know of an alternative drug or allogeneic therapy that addresses scleroderma? If not, and we are successful then the question becomes how easy will it be for competitors to come up with an alternative therapy?

Given that the SVF is a complex agglomeration of therapeutic ingredients that may be effective due to its unique composition, how easy is it for a competitor to identify the necessary vital components that produce efficacy and create a UNIQUE product that will compete with autologous SVF? How long would it take to develop and test such a drug? Quite a while I would imagine.

In the case of allogeneic would we be using one individuals SVF which will be expanded into 1 million doses? How will the various components of the SVF react? Will they have differential expansion rates and how will this affect efficacy? Lots of questions.

Also if cryopreserved autologous SVF is efficacious (Scleredac II) would there not be a major demand for having your own unique cell therapy backup medicine cabinet? Especially as we are getting strong indications of efficacy from independent investigator studies (IIS) in a plethora of indications.

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Fat and Furious:Harnessing the Potential of SVF 14 Jan 2017 20:07 #8510

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WST and rongside

I still say the answer is Cytori will only be a niche player.
They may hold the scleroderma market and perhaps some nice pieces of other markets but if we have learned anything (imho) the promise of the therapy is not as broad based as one thought. Other disciplines will indeed compete at some point. If not in the stem area itself other biologic or combo of drug and biologic treatments. Gene editing could be very interesting.
Longer term the only real solution is a buy out.
Maximum effectiveness will need this out of current hands !

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Fat and Furious:Harnessing the Potential of SVF 14 Jan 2017 22:14 #8511

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Yes, Cytori has potential first mover advantage in scleroderma. No one can dispute that. However when it comes to partnering with the autologous model, history has shown that it is VERY unlikely. the barriers to entry for SVF are seemingly non existent. Its just a matter of who wants to invest in a trial to get FDA approval. Not many are going to take the plunge in autologous.

I just came across a large adipose derived stem cell stroke trial underway in Europe. Guess what? its allogeneic. www.resstore.eu Hedge is correct about a niche market and the amortizing debt is still a huge problem in the interim, especially given the lack of volume.

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 09:04 #8512

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HF says that CYTX will only be a niche player holding the scleroderma market and perhaps some "nice" pieces of other markets. If that turns out to be the case then we are looking at probably "only" a twenty times valuation increase. I'll take it as a minimum case!

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 09:15 #8513

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Two things to contribute to the partnering topic:

The presentation in San Francisco did not mention anything about partnering. Perhaps the audience was not right to talk about partnering, I don't know. But, I feel sure the topic was left out intentionally. Why? Have they come to realize it isn't going to happen? It never has with the exception of Lorem and that turned out to be a disaster. That partnership has deteriorated to a supplier/customer relationship with no sales since April 2015. I don't draw any inferences from this omission except that I noticed it.

About a month ago, I spoke with Hedrick for about an hour. I specifically stated to him that WST does not believe the autologous business model is capable of finding a partner. His response: "WST has no intellectual basis for drawing that conclusion. There are issues with both allogeneic and autologous." This seems to be a departure from a past admission to WST that the autologous business model was, in fact, a partnering hurdle. Perhaps some of the obstacles have been addressed.

Personally, I think the reason there has been no partner in scleroderma is a perception of valuation. This judgement call falls squarely on the backs of Hedrick and Rickey. It is my opinion, the company believes a worldwide partnership, ex USA, is worth hundreds of millions of dollars. Note John Harris' reference to worldwide peak annual revenue from Habeo of $1.6 Billion. Based on that statement alone, I can see why a properly valued partnership should be worth hundreds of millions of dollars. Obviously, he has not been able to convince a strategic to agree. Thus, Hedrick will not sign a deal and has chosen to fund the company's cash needs with Lincoln Park Capital. In other words, in my opinion, Hedrick believes shareholders will be better off with another 30% plus dilution than to sign a deal for peanuts. The next potential event that could cause a strategic to reassess the valuation is clearly the STAR data on Scleroderma AND Raynaud's (Habeo) coming out in mid July. If Hedrick is correct, he will be a hero. If not, the company will have to go to market without a partner and that will result in the full 75 million shares authorized to be outstanding.

Revenues did not ramp up fast enough in Japan and the MAP bureaucracy and understaffing caused delays in that revenue source. As a result, there is not enough money to get to the STAR results without dilution. If the real problem is the autologous business model, then the stock will not move higher even after P Values of <.001 from the STAR trial.

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 10:48 #8514

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I am sure most noticed the absence of partnership talk in the latest presentation and we can go back to the Q3 earnings call to hear Hedrick say he would not sign a bad deal. This stood out to me at the time as there must be obvious valuation issues with whomever they were speaking to. Otherwise, no need for such a statement.
What happened to the small deals Hedrick talked about ? Kerastem was quite small but needed capital came in.
It might be CC all over again...dis, should be thrilled...LOL
Back to the recent slide presentation, didn't the est. scleroderma market numbers seem lower than what has been tossed around in the past.
Lastly, they better get the volume up somehow or LPC wont be much help either.
PS
On the good news front, Hedrick and co. haven't got their options yet so the lower the better !

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 11:46 #8515

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DOV, excellent post - I think that your quote from Hedrick on autologous vs. allogeneic partnering is totally correct re problems with both.

One point that I want to make clear is that I believe that there are many smaller partnering possibilities for CYTX that can get us through to breakeven without touching a dime of LP money - it does not have to be the large deal re scleroderma that you mentioned. JMHO.

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 11:55 #8516

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RS
It would sure be easier if CYTX could show demand for their product !
Unfortunately to date, they have shown the exact opposite.

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 11:57 #8517

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HF, the obsession with you and others on option pricing is absurd - imo, Hedrick and his staff would like nothing better than for CYTX to double next week even if it is before option pricing - the "option period" is long enough that increases at these low levels means nothing - if the Company succeeds, the sky's the limit!

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 13:16 #8518

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Rodney,

I totally disagree with you concerning the options. Here's why!

Last year, options were granted on the very first trading day of the year at $.19 ($2.85 now). They actually thought the stock had bottomed as a result of tax loss selling and consciously wanted to get the lowest price so they granted them three or four weeks early. In addition, Hedrick got 4 times the number of options than usual. This basically said all of those 974,000 options that Hedrick accumulated over the last ten years at prices from $.48 to $7.04 ($7.20 to $105.60) are worthless and need to be replace with new ones at $.19 ($2.85). It will be interesting to see the quantity of options granted this year. The stock dropped 47% during 2016 so the grant price is what it is on the day the BOD meets.

The reason the stock option grants are so important to Hedrick et al is because the company could get bought out by any company lurking on the sidelines but has not signed a NDA. Once the data is out, a big Pharma could come in and offer $15 a share and steal the company along with all of its potential upside. At that price most of Hedrick's old options would not even be in the money. This is the last chance to get cheap options before the STAR data comes out. In a self serving way, it is human nature to hope the stock stays down until after the options have been granted.

Now if the question is, would they hold off signing a deal or announcing one until after the options are granted? That is specifically illegal just like back dating option grant pricing to pick the low. That scandal was popular back in 2006, I think.

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 15:18 #8519

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DOV, the BOD can grant more options than usual to Hedrick (as it did last year) and others, but it cannot actually reprice the old options or cancel them and issue new ones to replace them. In terms of Hedrick's existing options, those at 7.20 and those under say $30 (with enough time before expiration) have decent value imo. Having said that, I do agree that this year may be more important to them as to the amount of options that they are granted, and perhaps they will be a bit more concerned about the exercise price because of the risk of hostile buyout (which imo is very remote).

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Fat and Furious:Harnessing the Potential of SVF 15 Jan 2017 22:15 #8520

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"

WST has no intellectual basis for drawing that conclusion. There are issues with both allogeneic and autologous."


That's a funny statement coming from Marc and I have little doubt DOV heard that statment. The entire premise of my view on this evolved based on basic logic and the practical evidence provided by the lack of autologous partnership deals while several several allogeneic deals have been done in the stem cell space. Not to mention that Tigenix and Capricr, two companies that converted from autologous to the allogeneic model. I recall that Marc once dismissed the idea that Japan would ever provide reimbursement based on conditional approval under the new laws there even though another CEO told me the exact opposite and was correct. I couldn't believe how the CEO of a stem cell company could get this wrong. Fool me once, shame on you, fool me twice shame on you, fool me thrice shame on you. Fool me four times or more, shame on ME! LOL!

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Fat and Furious:Harnessing the Potential of SVF 16 Jan 2017 08:06 #8521

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CYTX has entered partnerships such as Olympus, Astellas and Lorem - they just have not worked-out (oftentimes as a result of the other partner), not unlike the broken ATHX partnerships with Pfizer and Chugai. Also, there are many more allogeneic companies than autologous and , as such, there will naturally be more partnerships for the former. As far as those that switched such as Tigenix, they had no choice because their autologous products were not very good.

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