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TOPIC: Glaucoma feasibility trial in Russia started

Glaucoma feasibility trial in Russia started 28 May 2014 11:57 #1725

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Surely some of you must have (like I did) had a closer look at the Burnasyan Federal Medical Biophysical Centre of the Russian Federation is Moscow, since several clinics have been reported in the past be myself and others using ADRCs and either Celution or Puregrafr for several indications.

This centre:

leans heavily to radiation treatment technology for which reason the use of ADRCs is not a big surprise. Looks more like the centralized research for the Russian BARDA. Link to their page - BMFB page

This ophthalmology clinic on glaucoma is pretty sensational. The eye is really one of the few "parts" of the body which are immune privileged meaning one can use "engineered- allo cells" without getting immune responses. Despite knowing that - the Russian dotors opted for ADRCs as method to heal a really common and devastating eye disorder which is prevalent all over the globe.

Bodes well if one can add one and one together.

Link to clinical trial gov page- Clinicaltrials.gov entry for clinic
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Glaucoma feasibility trial in Russia started 29 May 2014 07:07 #1727

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I woder if US sanctions on Russia will interupt this lucrative $40K consumable deal ?

Lots of small trials...mostly hidden data....no reimbursement in sight for any of it any time soon....and that is the real key as we await the next funding raise.

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Glaucoma feasibility trial in Russia started 29 May 2014 07:09 #1728

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guess I should have spelled out the forty thousand sales amount ! :KO: :really: :write:

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Glaucoma feasibility trial in Russia started 29 May 2014 07:58 #1729

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Hedge-

This clinic has nothing to do with share price or anything like that. Just possibly more evidence that ADRCs most likely represent disruptive technology.
If you spoke to one of the Marx Brothers they most likely would not want to know about it nor wanting to talk about it, but there also are scientists at a lower level at Cytori that do think that the potential for neuro-degenerative disorders of fat cells is extremely promising and this clinic to my knowledge is the first actual neuro clinic on humans.

Obviously - Advanced glaucoma is nothing else but damage to the optic nerve which disturbes the communication with the brain and causes partial or full vision loss. It is an unmet need and very important if this works.


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Glaucoma feasibility trial in Russia started 29 May 2014 08:11 #1730

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I guess, most folks know about glaucoma. If you dont - here is a small description of its causes-

Glaucoma usually occurs when pressure in your eye increases. This can happen when eye fluid isn't circulating normally in the front part of the eye. Normally, this fluid, called aqueous humor, flows out of the eye through a mesh-like channel. If this channel becomes blocked, fluid builds up, causing glaucoma. The direct cause of this blockage is unknown, but doctors do know that it can be inherited.
Less common causes of glaucoma include a blunt or chemical injury to the eye, severe eye infection, blockage of blood vessels in the eye, inflammatory conditions of the eye, and occasionally eye surgery to correct another condition. Glaucoma usually occurs in both eyes, but it may involve each eye to a different extent.


This comes from WebMD, but is really incomplete- the pressure build up normally causes damage to the optic nerve- see picture-



From my own experience- 20 odd years ago I visited an eye clinic in Ludwigshafen and the folks increased the eye pressure with some procedure- than they measure the time it takes for the eye to recuperate itself. If it takes more than a certain standard- you most likely have glaucoma.

About 7 years ago - I had a full scan of my optic nerve- everything was still in the "green" and my only problems at present are cataracts, which are mainly age related. Those are standard procedure and easy to fix. Will have them done soon.
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Glaucoma feasibility trial in Russia started 29 May 2014 08:15 #1731

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Another topic- the detailed procedure described by the clinic investigators of what they are doing is HIGHLY INTERESTING.

I have never seen such a detailed description of the procedure they follow- excellent for newbees and advanced folks alike- :happy:

Fat tissue obtainment:

Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.

ADRC isolation:

Aspirated fat tissue placed into sterile vessel which inserted into Celution 800/CRS System (Cytori Therapeutics Inc) - closed system for automated and standardized extraction and concentration of ADRC. Celution 800/CRS System drains excess of fluid from fat tissue and estimate it's volume After that lipoaspirate washed extensively with equal volumes of Ringer's solution to remove blood. At the end of this process System indicates required volume of enzyme reagent (Celase®) which should be added immediately by operator. After enzyme treatment Celution 800/CRS System automatically transfers isolated ADRC into washing compartment where ADRC washed and concentrated in 5 mL suspension. Tissue processing time - approximately 60 minutes. ADRC suspension match all requirements listed in technical documentation for Celution 800/CRS System. Obtained ADRC divided into 2 portions. First portion (0.2-0.5 mL) used for counting, viability and sterility assessment. Second portion placed into sterile syringe for injection.

Subtenon injection of ADRC:

Antiseptic and anesthetic solutions instilled into conjunctival sac. After that blepharostat installed. The patient is asked to look in opposite to the injection side direction. Doctor inserts a needle into inferior temporal quadrant between rectus muscles,10-12 mm from the limbus. Needle should be moved slowly, as close as possible to the eyeball. After needle placement at the depth of 5-7 mm doctor injects concentrated solution of ADRC (up to 0,5 ml per single injection). Injection is made by insulin syringe with a needle size 0.45 mm * 12mm (26 G).
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Glaucoma feasibility trial in Russia started 29 May 2014 08:18 #1732

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First portion (0.2-0.5 mL) used for counting, viability and sterility assessment.

Here it is very likely that the cells viability are being tested with Sistemic QC. A standardized method to measure the variability of the inputted cells and relate to outcomes by individual patient. :cool:

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Glaucoma feasibility trial in Russia started 29 May 2014 08:48 #1733

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Nice to see you putting up new material on the board fas. Are things healing as they should?

d9

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Glaucoma feasibility trial in Russia started 29 May 2014 09:10 #1734

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Yes D9- thanks for asking, but everything i.e the colon, is back up functioning like it should be.

June is a month up here, when all doctors seem to be gone, so I will complete my pre-retirement "physical maintenance" program in July and August.
If all goes well- we will see some appreciation in regenerative technology this year, particularly - the fat side of things- and will be able to continue developing my websites and possibly visit the west-coast in October to see my A´s in the post-season. :woohoo:

Time will tell- am optimistic as usual. :yawn:

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Glaucoma feasibility trial in Russia started 29 May 2014 16:11 #1735

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Fas,

A member of my family has a rare autoimune disorder called Susac Syndrome. Part of the therapy is to track the progress of the disease using a procedure called fluorscein angiography. Eyes are dialated and die is injected intravenously. Photographic scans are then captured in time which illustrate the health of the perupheral capillaries extending from the optic nerve. Damage (demilenation) shows up as bright spots due to leakage in the affected nerve endings. Since Susac attacks the smallest vessels at the perihery of the eye this test is the only way to see what is going on with the disease. The disease is treated with infusions of imune system surpressors. Because the disease attacks the perifphery of the vessels MRI scans are not the optimum although they are used as a baseline for changes in brain activity. Susac is treatable and can go into remision. I am praying that the day comes when we are rid of Susac forever.

The reason I am giving you this information is because I have seen many of these optic nerve scans and can testify to the complexity of the optic nerve. The scans look like a picture from outer space. Like a galaxy with tentacles extended to the outer reaches of the universe. The shear number of vessels (those we can see!) tell me that regenerative cells must be pursued as a therapy for ischemia in the eye. Damage to the vessels extending from the optic nerve will cause blindness. The eye is a unique organ. I think that stem cells will be found to be useful in treating ischemic disease in the eye.

www.revophth.com/content/d/retinal_insider/i/1225/c/23061/

www.acnr.co.uk/2013/03/new-developments-in-susacs-syndrome/

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Glaucoma feasibility trial in Russia started 29 May 2014 17:41 #1736

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Fas
Agree that although Macular Degeneration has made strides in treatment...glaucoma treatment continues to be limited.

Treating a damaged optic nerve may help some but without the relief of the increased optic pressure it would seem the damage would/may simply re-occur. I wonder if somehow the angiogenisis effect of ADRC's couldnt aid in the fluid issue. Granted this seems a stretch.

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Glaucoma feasibility trial in Russia started 29 May 2014 19:23 #1737

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Fas, thank you for this site... I am so thankful that you're here and posting all this stuff... I don't know you do it, with so many negativity around... :winky:

Great stuff... :vegas:

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Glaucoma feasibility trial in Russia started 30 May 2014 12:54 #1741

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Fatboy-

Thanks for all the information. You probably have a point on the "method of therapeutic action" being resolving of ischemia issues in the eye.

The investigators do not disclose anywhere how this should work, but it is likely that just like angiogenesis within fat tissue supports the new tissue and prevents it from dying like in breast reconstruction, ABSOLUTELY the same principle applies in muscle tissue in the sphincter, new bone tissue in your shoulder, new cartilage tissue in your knee or supporting development of tiny arterioles in occular tissue.

Simply combatting ischemic disorders and a few other "beneficial mechanisms of healing action" :vegas:
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Glaucoma feasibility trial in Russia started 30 May 2014 14:48 #1743

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Fas,
The eye being such a dynamic organ with special protocals for accepting introduced matter does seem to be an excellent candidate. I think the Russians are injecting right into the ocular fluid. The complication is finding a pathway to the damaged arterioles. Just "bathing" the tissues in the "gemensch" does not seem to be optimal. That is why we need a breakthrough.

Tough one against the Tigers yesterday. Good luck against the Angels. You come to NY next week to play my Yanks. :vegas:

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Glaucoma feasibility trial in Russia started 30 May 2014 18:22 #1744

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Fas, forgive me, but you make two definitive statements here that I cannot comprehend, unless you have proof that will not happen… Please indulge me and explain to me why warrants will not be extended, even though it was just done a few weeks ago. Also, about BARDA, even though you are correct to make that statement, but there are a multiple scenarios that BARDA can modify the contract in a way that CYTX can realize revenue…

I am not a dreamer, and do accept my potential loss in my warrants, I’ve never left the poker table with only a few chips left, unless I knew it wasn’t going to be my day. The art of trading is going to play out in a few weeks, and knowledge will help us make the most out of these trades.

The rich plays the stock market with full knowledge, from both technicals and fundamentals view-point advantage.
If you think CYTX will be diluting for the next several years without any revenue, then there is something wrong with your approach, I am just trying to make sure you are not making these comments based on frustration.

I do believe that BARDA’s payment will start an impulsive bullish wave, charts will tell us how high it will go, so I know I am going to make a good trade… but again, understanding why you are making those statements, will make a heck of a difference.

Thanks!

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Glaucoma feasibility trial in Russia started 31 May 2014 10:06 #1745

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Cytxer-

Just accept that the statement on the warrants does not come from me personally, but from the group that initiated the secondary back in April 2009.
There is also "Cytori History" attached to this (where I certainly has most documentation and knowledge). That is: the March 10 secondary with the 1,75 traded warrant attached, must have been an absolute desperation act from Mark Saad at the time. His option C or D so to speak, since he personally also knew about the front running activities of the Piper Jaffray clients. Just have a look at the volatility for the period March 5 to March 20 2009. You will understand what I mean. Actually- of the 6.7 Mio warrants roughly 2.5 are already converted. Those were shorts hearing that a deal was coming up- it never came though :grin: :grin: but it pushed the OS short number from 10 Mio to 7.5 at the time . :joy: :joy:

Anyway- the May warrants were/are in the hands of 37 known and accredited investors (some of whom helped Cytori in the early years) and with whom deals can be made.
The September warrants basically were issued to the short side (Piper Jaffray) are in "street name" and nobody knows who holds them now.

Well- I do...a lot of them....time will tell. :evil: :whistle:

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Glaucoma feasibility trial in Russia started 31 May 2014 10:29 #1746

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Also Fas, With the shorts big cover it allowed plenty of dry powder to continue to control the PPS post Lorem deal, ect.

Still feel we need that serious sales ramp to break the cycle of this low PPS and they will be willing to gamble with additional shorting on pops on news

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Glaucoma feasibility trial in Russia started 31 May 2014 10:38 #1747

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On BARDA-

Lets just say, that BARDA money cannot be spent on providing a big performance bonus to Townsend (the controller) and Saad (the CFO) for getting a qualified opinion on the 2013 accounts and making sure that more than 20% of 2013 revenues were written off to bad debt. :bash: :bash: :bash:

The money will be spent on specific cost elements, which EXCLUDES CORPORATE spending, which simply happens to be the bulk of Cytori expense. :cry:

The charm of BARDA is not its 56 Mio or 106 Mio to be "spent" ( on average 120 high level employees have spent MUCH more in the past 12 years!!! :bang: ), but ignition or catalyst impact it COULD have.

Locking "in" the US government as customer could certainly not only persuade a Big Player to deal with Cytori, but also persuade global BARDA´s to follow suit on their US colleagues. To me the Japanese, Arab Oil states and G5 are excellent candidates. :grin:
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Glaucoma feasibility trial in Russia started 31 May 2014 18:09 #1748

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Millions more will go down the sewer in SanDiego Fas before this has a chance of seeing cash flow positive :evil:

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Glaucoma feasibility trial in Russia started 02 Jun 2014 08:40 #1749

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Thanks fas!

I agree with both comments, and I think you are absolutely correct on results of BARDA payment.. 100%

Old longs seem to lose perspective when deep in red... A BARDA payment COULD make a total difference in image and anything goes with this market.

GL

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