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TOPIC: Is this new: CYTORI CELL THERAPY TM?

Is this new: CYTORI CELL THERAPY TM? 21 Nov 2016 07:56 #8073

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Today's PR on wound healing cites CYTORI CELL THERAPY.

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Is this new: CYTORI CELL THERAPY TM? 21 Nov 2016 08:41 #8074

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franshei wrote: Today's PR on wound healing cites CYTORI CELL THERAPY.


This is one of those "Stockholder´s Notes", which there should be more coming since informative.

As previously announced Cytori presented 2 papers at IFATS 2016, which this time was held in San Diego. Normally an Ebook is published after the meeting with all abstracts, which I already look forward to. They tend to be interesting reading material, to see what the trends are.

The text of the Note is below:

Over the weekend Cytori scientists presented two research papers at the annual meeting of the International Federation of Adipose Therapeutics and Science (iFATS) in San Diego. Both papers highlight research done in preclinical models of corneal injury and hypertrophic scarring and demonstrate how Cytori's cellular therapeutic may improve healing following corneal injury and as well as reduce hypertrophic scarring.
The first presentation titled “ADIPOSE-DERIVED REGENERATIVE CELLS PROMOTE PROLIFERATION OF CORNEAL EPITHELIAL CELL AND CORNEAL WOUND HEALING”included data showing that tissue culture medium conditioned by Cytori Cell Therapy™ cells increased the viability of serum-starved corneal epithelial cells. Based on these results Cytori scientists led by Visiting Scientist Dr Yoshihiro Nakagawa executed follow-on studies using standard corneal explant organ culture. These studies showed that topical administration of Cytori Cell Therapy™ significantly reduced corneal wound size compared to control treatment.
This finding suggests that Cytori Cell Therapy™ has the potential to improve healing of corneal epithelial injuries. These data align very nicely with preclinical data showing improvement of healing of cutaneous epithelial injuries including those caused by thermal burn. -
The second presentation titled “AUTOLOGOUS ADIPOSE DERIVED REGENERATIVE CELLS (ADRCS) THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERTROPHIC SCARS USING A RED DUROC PORCINE MODEL” included data indicating that Cytori Cell Therapy mitigates the development of hypertrophic scarring, a major source of morbidity following thermal burn and other cutaneous injuries. This presentation updated and expanded upon early data in this model presented earlier this year at the American Burn Association.
In this study the effect of Cytori’s DCCT-10 cell therapy for hypertrophic scarring (HTS), a common consequence of burn injury was assessed. Data demonstrated that delivery of product immediately after injury led to a decrease in skin hardness compared to control wounds. Histological analysis revealed an increase in the number of rete ridges (p<0.001) which are a key feature of the skin acting as an anchor between the epithelium and the dermis. Absence of rete ridges is a well-recognized characteristic of hypertrophic scars. The data further show an increase in elastic fibers length (p<0.05) and a decrease in scar vascularity (p<0.05) following DDCT-10 treatment compared to control. Molecular analysis showed that DDCT-10 up-regulated expression of wound repair-related genes but down-regulated expression of pro-fibrotic ones.
These findings extend our previous work and suggest that the improvement of healing seen following treatment with DCCT-10 extends beyond simple improvements in epithelialization to longer-term improvement in scar and skin function.
Current standard of care for burn wounds now consists of dressings, skin grafts, and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from hypertrophic scarring. Autologous Cell Therapies such as those offered by Cytori may have the potential to improve the quality and rate of wound healing and reduce scarring.
In summary, these reports add to the already strong body of preclinical data supporting the potential of Cytori Cell therapy™, provide us with new models we can use to probe more deeply into mechanism of action, and provide additional support for potential expansion of our ongoing activities supported by BARDA.

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Is this new: CYTORI CELL THERAPY TM? 21 Nov 2016 08:47 #8075

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Nice, but pre-clinical research at this point isn't going to help the balance sheet.

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Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 09:53 #8077

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The 2016 Program book of IFATS is out now, so the abstracts are available too:

first the pig study-

AUTOLOGOUS ADIPOSE DERIVED REGENERATIVE CELLS (ADRCS) THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERTROPHIC SCARS USING A RED DUROC PORCINE MODEL

Presenter: Philippe Foubert, PhD (USA)

Affiliation: Cytori Therapeutics

Authors: Foubert P, Liu M, Zafra D, Rajoria R, Gutierrez D, Tenenhaus M, Fraser JK

The use of non-cultured autologous Stromal Vascular Fraction (SVF) or clinical grade Adipose Derived Regenerative Cells (ADRCs) cells represents a promising strategy to reduce hypertrophic scar (HTS) formation and progression, a common consequence of burn injury. The purpose of this study was to explore the influence of delivering ADRCs at time of injury (prophylactic approach) or in established HTS using the Red Duroc (RD) Porcine Model. Bilateral pairs of deep partial thickness excisional wounds (2mm deep; 58 cm2) were created using an electric dermatome on pigs (n=14). For the prophylactic approach, ADRCs or control vehicle were directly sprayed onto the wound following injury.
For the treatment approach, ADRCs or control vehicle were injected into the established HTS six months following injury. Weekly and monthly assessments of wounds included digital imaging, hardness, pigmentation measurements and biopsy procurement at 6 months post-treatment. For the prophylactic approach, results demonstrated that delivery of ADRC product immediately after injury led to a 15% lower skin hardness compared to the paired control wound (p=0.067). Preliminary histologic analyses collected at 6-months post-injury revealed changes in collagen organization and epithelium morphology. Control vehicle-treated wounds exhibited irregular arranged collagen bundles oriented parallel to epidermis. Conversely, ADRCs-treated wounds had quasi randomly arranged collagen fibers.
Quantitative analysis showed that delivery of ADRCs immediately after injury led to a 60% increase in the number of rete ridges within the epidermal junction (p<0.001) of treated wounds compared to the control. Data from the therapeutic strategy showed that ADRC treated scars exhibited 20-40% lower skin hardness than paired control scars up to 4 months post-treatment (p=0.041). This study is ongoing and evaluations at 6-months post-treatment are pending. For both studies, ADRC delivery showed no effect on scar pigmentation or erythema.
These data indicate that autologous ADRCs delivered at the time of injury or within mature scars modulate the HTS response. ADRCs may represent an effective anti-scarring therapy as stand-alone therapeutic or in combination with other anti-scarring agents.

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Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 10:08 #8078

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The second paper is the more interesting one, because of the presenter and the application- corneal (eye) injury. Remember that some experience already exists in Moscow where 12 patients with severe glaucoma were treated.

Anyway- the paper first-

ADIPOSE-DERIVED REGENERATIVE CELLS PROMOTE PROLIFERATION OF CORNEAL EPITHELIAL CELL AND CORNEAL WOUND HEALING

Presenter: Yoshi Nagakawa, PhD (USA)

Affiliation: Cytori Therapeutics

Authors: Foubert P, Nakagawa Y, Liu M, Zafra D, Fraser JK

Introduction: Diffuse corneal epithelial injury often causes poor outcomes. Immediate and appropriate management is related to visual prognosis. Adipose-derived regenerative cells (ADRCs) have gained increasing attention as a source of regenerative therapy because of their abundance, easy accessibility and capacity for tissue repair. In this study, we investigated the in vitro and ex vivo effects of ADRCs during corneal wound healing.

Methods: ADRCs were isolated from human adipose tissue by using the Celution® CRS/800. Following isolation, ADRCs were used to prepare conditioned media (CM) collected at day2 (fresh-CM) and day 5 (short-CM). Serum-starved human cornmeal epithelial cells (HCECs) were co-cultured indirectly with ADRCs or its CMs and, HCEC viability was determined using the Resazurin assay. In addition, the effects of ADRCs was investigated suing an ex vivo corneal wound healing. Porcine corneal injury was induced using 8mm biopsy punch and wounds were treated with freshly isolated ADRCs or control vehicle. Efficacy of treatment was monitored by fluorescein penetration test and wound size was determined by imaging 60hrs post-treatment.
Results: Using the Resazurin assay, ADRCs were able to significantly increase HCECs viability compared to control media in a dose-dependent manner (n=6, p<0.01). In addition, both fresh- and short ADRCs CM increased HCEC viability compared to control (p=0.003, p<0.001, n=6). Finally, topical application of freshly isolated porcine ADRCs significantly improved corneal epithelial wound healing ex vivo (p=0.028, n=4).

Conclusions: These preliminary data showed that ADRCs promote corneal epithelial wound healing. Our data suggest that ADRC improve corneal function through secreted factors. ADRC therapy may represent a novel promising cell therapy with high potential for translation in ocular diseases treatment.

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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:

Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 10:22 #8079

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The Cytori announcement spoke of a guest scientist involved in the study and not a Cytori employee.

That obviously raises a flag of possible cooperation between entities, since Cytori is not blessed with hard $$$ to conduct pre-clinical studies in areas where they have no immediate interest..:whistle:

Now- Yoshihiro Nagakawa is according to my research, a scientist from Kanagawa (Tokai University- Ophthalmology Deptm.) and from the sister departments several PI trials in liver and cardiac are in my memory. Possibly Astellas is not all that convinced of formerly ATCT technology after all and still looking around and experimenting in the arena. :whistle:

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Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 13:20 #8080

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Ah yes, Astellas. Who remembers what they paid. Was it $7.00 pre-split ?
Its tax loss selling season.
Balance sheet shows more debt than cash.
RS is quite sure Sabby is buying and will defend the 52 week low...LOL They cleverly hide it by no volume to speak of what so ever.
News out of Cytori shows that someone, someday, may take advantage of their tech. Its just still unclear if Cytori and its shareholders will participate !

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Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 14:20 #8081

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myownhedgefund wrote: Ah yes, Astellas. Who remembers what they paid. Was it $7.00 pre-split ?
Its tax loss selling season.
Balance sheet shows more debt than cash.
RS is quite sure Sabby is buying and will defend the 52 week low...LOL They cleverly hide it by no volume to speak of what so ever.
News out of Cytori shows that someone, someday, may take advantage of their tech. Its just still unclear if Cytori and its shareholders will participate !


Yeah.. it was 7+ $ pre-split and we are are at 11 cents pre-split now. Hedrick is really looking forward to his 1.2 million pre-split option shares on Monday January 2, 2017. And yes- the danger of a third party running away with the "fruits of the tech" is increasing by the day. As long as those facts have not occurred I will keep the faith.

There is little else to do besides repeating the same old crap over all the time, is there?

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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:

Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 15:18 #8082

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***There is little else to do besides repeating the same old crap over all the time, is there? ***
Perhaps you are right Fas.
Maybe DOV thought the same in leaving his bullish spread sheet unchanged despite the quarterly report.
As for me, I will take a respite and unless MAJOR news of REAL importance arises will come back to the board in a posting manner sometime the week of December 19th of this year.
Parting thought, some may want some dip for their potato chips this time around :(

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Is this new: CYTORI CELL THERAPY TM? 22 Nov 2016 19:46 #8083

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FAS

I think CYTX has finally realized they need to leverage out scleroderma and all the potentials related to this indication to find a global partner. New money is needed and it can solve a lot of problems, including a decent stock price.

As you had commented before that Hedrick had rejected an earlier partnership offer for scleroderma in the US, It is very likely that the offer might be inadequate. CYTX needs a full plate on the table to get a decent deal. It is possible that the plate is much fuller now with other related medical applications (as mentioned by Hedrick in the 3rd Q conference call), single and mutiple local dose administrations (as indicated in the US orphan drug designation).... The potential partner may even ask for iv dosing rights when some bodily organs (such as the lungs) are involved - since iv doses may involve the use of CTX2, CYTX may not agree to this proposal (but the potential partner can always for the the rights of first refusal).

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Is this new: CYTORI CELL THERAPY TM? 23 Nov 2016 08:36 #8084

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franshei wrote: FAS

I think CYTX has finally realized they need to leverage out scleroderma and all the potentials related to this indication to find a global partner. New money is needed and it can solve a lot of problems, including a decent stock price.

As you had commented before that Hedrick had rejected an earlier partnership offer for scleroderma in the US, It is very likely that the offer might be inadequate. CYTX needs a full plate on the table to get a decent deal. It is possible that the plate is much fuller now with other related medical applications (as mentioned by Hedrick in the 3rd Q conference call), single and multiple local dose administrations (as indicated in the US orphan drug designation).... The potential partner may even ask for iv dosing rights when some bodily organs (such as the lungs) are involved - since iv doses may involve the use of CTX2, CYTX may not agree to this proposal (but the potential partner can always for the the rights of first refusal).


I definitely hope you are right and that what has been said at the last CC comes true. It would be the first time in 10 years, so that will be a gigantic change.. :yep:

In all respects, Hedrick is sounding now. like Calhoun always has- just less inspired lets say...- "we will not make a bad deal for the Company".....is the word, I so wish I could be the judge of that instead of Hedrick with his greed. Anyway- we are entering holiday season again, for the 10th time with some hope. In our family I am the only one left, who is still believer due to the technology. All faith is gone with the other family members. :cry:

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Is this new: CYTORI CELL THERAPY TM? 23 Nov 2016 21:23 #8085

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FAS

Hedrick says he would not make a bad deal; he also says he what he would do is to enhance the stockholders' value. His CFO says the same thing. All of us have heard the same again and again, over and over for the past 2 plus years.

Yet, no real deals have come through and yet, they would prefer to raise money by making the worst decisions without benefiting the company and all the stockholders.

I wish Hedrick and Girao would wake up and do something more meaningful rather than just making empty statements.

(Scary thoughts behind all the bad decisions and empty promises: 1. stem cells therapy (the whole segment of biotechs) does not work at all ( big question mark). 2. cytori technology does not work or no one believe in this technology. 3. Our last chance in scleroderma would not work out (does it or does it not?).)

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Is this new: CYTORI CELL THERAPY TM? 24 Nov 2016 20:43 #8088

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REALITY CHECK: They won't take a bad deal and there will be no good deal. The autologous model is the main problem. The idea that Cytori will send a technician to create each batch (if that is still the plan in the U.S.) so it can manufacture its "drug" is a non starter to any partner. Think of how that sounds when they talk to a partner unfamiliar with the situation for the first time. Correct me if I am wrong but is that still the U.S. model for Scleroderma?

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Is this new: CYTORI CELL THERAPY TM? 25 Nov 2016 08:56 #8089

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The main question is does Cytori cell therapy works in scleroderma, as well as in combat wound healing. If it really works (US marketwise with clinical studies performed per US drug testing requirements/FDA), qualified technical supports for 40 scleroderma centers should be instituted somehow and should be much easier than it would be for OA among community physicans (beyond specialized stem cells treatment centers).

In the case for military use/uses in specialized burn centers for CXT2 in combat/thermal-radiation wound healing, I think qualified technical supports can always be found.

If the cytori cell therapy really works in the above indications for the US market, CYTORI really needs a strong customer/technical support training group - is this what Cheri Rice is working on now.

It looks like the same apply for overseas market in which cytori cell therapy may find more acceptance among specialized treatment centers rather than among community physicians.

I think it is fair to say CYTX may have to play solo till at least the release of the phase 3 scleroderma clinical data.

Just my thoughts.

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Is this new: CYTORI CELL THERAPY TM? 26 Nov 2016 08:59 #8091

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I am quite sure that we will see a meaningful deal(s) in Q-1that will help carry our cash position through until breakeven in 2018. JMHO. :yep: :nice:

PS - Stay positive boys - the game is definitely not over! :joy:

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Is this new: CYTORI CELL THERAPY TM? 26 Nov 2016 09:36 #8092

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Rodney Strong, I am glad you are here instead of Yahoo.

I think we should all be very skeptical what Tiago Girao might have said off the cup. But, we may trust what he wrote on the 3rd Q release on current financial strategy to float the company till mid 2017: cash on hand plus ATM plus some very small deals (project wise) here and there plus cost cutting (please read the 2015 Annual Report re management reply to Going Concern).

Regarding cost cutting, scleroderma active clinical phase in the US is done and the cost for the new BARDA phase 1/2 trial will be undertaken by the government.

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Is this new: CYTORI CELL THERAPY TM? 28 Nov 2016 19:34 #8093

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Rodney Strong,

I am sorry to be skeptical regarding a possible deal during Q 1, 2017.

Should there be a scleroderma global deal (not just Japan or US or EU, per Hedrick during the 3rd Q call), my guess is: it may come from Japan (as I had mentioned a while back).

My reasons are:

1. Japan, China and Korea (patients and governments) are receptive in cell therapy and Japan has clear regulatory guidance, of which Cytori is most comfortable with. (It is not the case here in the US).

2. We are very lucky to have Harris heading Cytori in Japan. He knows the regenerative medicine market and he has great connections there and he may have found an appropriate partner, which would like to have a global presence in regenerative medicine. Does Hedrick's Japan visit in early November have something to do with this possibility? (Harris and Hedrick seemed to be in good mood during the 3rd Q call from Tokyo.)

3. I think large US medical device companies would not be interested in a small indication, such as scleroderma. The interest in EU is probably limited. OA would be different.Cardiovascular indications could draw vast interest (but I think FDA approval for stem cells in these indications and stroke would be very difficult in general).

4. Since the 3rd Q conference call, no cytori insiders have traded the stock during the 30 day open period. One possibility: unless there is material news coming and they are not allowed to trade. (Harris usually buys some shares during this 30 day period.)
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Is this new: CYTORI CELL THERAPY TM? 29 Nov 2016 05:06 #8094

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Franshei, none of the points in your post suggests that there will not be a deal in Q-1, only that it will be in Japan - I agree on that point.

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Is this new: CYTORI CELL THERAPY TM? 29 Nov 2016 06:54 #8095

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franshei wrote: Rodney Strong,

I am sorry to be skeptical regarding a possible deal during Q 1, 2017.

Should there be a scleroderma global deal (not just Japan or US or EU, per Hedrick during the 3rd Q call), my guess is: it may come from Japan (as I had mentioned a while back).

My reasons are:

1. Japan, China and Korea (patients and governments) are receptive in cell therapy and Japan has clear regulatory guidance, of which Cytori is most comfortable with. (It is not the case here in the US).

2. We are very lucky to have Harris heading Cytori in Japan. He knows the regenerative medicine market and he has great connections there and he may have found an appropriate partner, which would like to have a global presence in regenerative medicine. Does Hedrick's Japan visit in early November have something to do with this possibility? (Harris and Hedrick seemed to be in good mood during the 3rd Q call from Tokyo.)

3. I think large US medical device companies would not be interested in a small indication, such as scleroderma. The interest in EU is probably limited. OA would be different.Cardiovascular indications could draw vast interest (but I think FDA approval for stem cells in these indications and stroke would be very difficult in general).

4. Since the 3rd Q conference call, no cytori insiders have traded the stock during the 30 day open period. One possibility: unless there is material news coming and they are not allowed to trade. (Harris usually buys some shares during this 30 day period.)


Thanks Franshei- excellent post and all valid points, also in my view.

I think we have a consensus on the board that the end of Q1 is D-day for the cash situation and not being in conflict with loan covenants. That is only 4 months away and Wallstreet has dealt with such a situation with Cytori many times in the past by shorting or outright selling of holdings with the "knowledge" that a secondary is in the works.

From my perspective, I agree with WST, that the ATM is only usable with volume and that would have to mean major news, so hardly an option. And you cannot wait with a secondary when your purse is almost empty in order not to endanger the Going Concern of the Company. :whistle:

For all those reasons I expect a DECISION still now in Q4 - either make or break- deal or secondary.

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Is this new: CYTORI CELL THERAPY TM? 29 Nov 2016 07:02 #8096

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Fas, re your post, the only decision on the cash issue in Q-4 would be notice of a secondary (which I rate as no chance) - any partnership decision will be after options have been granted in January.

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