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TOPIC: When you thought you had it all...

When you thought you had it all... 05 Aug 2014 15:53 #1966

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This comes- an update on ATHENA or better a HOLD on the clinic....

CYTX has placed enrollment in the ATHENA and ATHENA II trials on clinical hold and therefore anticipates that it will not be possible to complete enrollment of the ATHENA I trial prior to the end of 2014 as previously anticipated. The decision to place the trials on hold was based on a safety review of reported cerebrovascular events. Symptoms occurred in three patients, of which two patients’ symptoms fully resolved within a short period of time and the third patient has had substantial resolution of symptoms. Such events had not been previously reported in Cytori’s other cardiovascular trials and appear to be related in part to the medical co-morbidities in the treated population and the complex nature of the procedures involved in the trial.

The U.S. ATHENA and ATHENA II clinical trials are randomized, double-blind, placebo controlled studies designed to evaluate the safety and feasibility of adipose-derived regenerative cells (ADRCs™) in heart failure patients with ischemic heart disease who are already receiving maximal therapy with no options for revascularization. The procedure involves a fat harvest through small volume liposuction, cardiac catheterization, electromechanical mapping of the heart to determine where to inject ADRCs (or placebo), the actual ADRC (or placebo) injection and related data collection and monitoring activities.

Cytori has been working with the FDA, an independent Data Monitoring Committee (DMC), trial investigators and external expert consultants to fully understand any adverse events and to carefully define adjustments to the protocol intended to minimize risks to patients and to improve the benefit to risk profile of the study.

Adverse events are expected in trials in which participants suffer from advanced cardiac disease and protocol revisions during phase II safety and feasibility studies in compromised populations are common. Cytori is committed to refining the trial protocol as needed, to mitigate risks as much as possible. Updated information regarding enrollment projections will be communicated upon final protocol revisions and agreement amongst the investigators, the DMC and FDA as to the safety and feasibility of continuing the trial as amended.


Cerebrovascular events are things that happen with the carotid arteries to the brain...i.e. can give you vision blurs and stuff like that and much much worse things , like a hemorrhagic stroke.
Normally with advanced HF cells placed with NOGA should not have an impact like what is suggested here, but you never know.

The PRECISE trial patients were mainly Spanish who all smoked like hell in their lives and all had severe hypertension... the high risk population for cerebrovascular events too.

We will see... maybe the "other" (unknown) cardiovascular studies on the globe will become more important now................. :KO:

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When you thought you had it all... 05 Aug 2014 16:02 #1967

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This is pretty morbid... but I just have been reading at Stemcellpioneers - the monthly "ask the doctor" contribution where the "Cell surgical Network" was on and they raved about the great impact SVF had on cardiac patients treated by their cardiology member....

The Wild wild west ... in the US... :bash:

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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:

When you thought you had it all... 05 Aug 2014 16:28 #1970

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I think I can speak on behalf of all LT investors that frequent this site, I'm absolutely sickened by this news. What else can go wrong with this company? I do hope that clarity comes rather quickly.

On the positive side, it at least appears that two of the patients have fully recovered and one has substantial recovery to date. Things could be a lot worse I suppose.

Now there's even more ammo for the shorts to use against the Cytori gang.

Good grief - what a day... :bang:

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When you thought you had it all... 05 Aug 2014 21:41 #1974

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I have never asked but I wonder if they do a ultrasound of the carotids before the procedure ? I would think it would be part of the protocol.

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When you thought you had it all... 06 Aug 2014 04:52 #1975

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On the positive side, it at least appears that two of the patients have fully recovered and one has substantial recovery to date. Things could be a lot worse I suppose.


and from the announcement-

Such events had not been previously reported in Cytori’s other cardiovascular trials and appear to be related in part to the medical co-morbidities in the treated population and the complex nature of the procedures involved in the trial.


I have been hearing that enrollment was STILL at a snail´s pace (wonder if they tell on 8-11- bet they do NOT... :KO: Personally I am very very suspicious really, If you remember the MSB trial on CHF which was only SINGLE blinded, >90% of placebo needed treatment within 6 months and >50% of treated patients were hospitalized again.
So far there were no casualties- this is a very very sick population- remember what the YMB patient (Mac- he is a member here too and I have been in contact with him before his procedure) said on the treatment? The doctor had to go up MANY times with his catheder to inject all the cells (15 times, I believe)
I know from personal experience- if you start poking around in the heart- plaque and stuff can get loose and start flying around in different directions. It CANNOT be the cells- IntraVase prevents clogging of the cells and with NOGA there are injected in TISSUE- not in an artery.

Obviously that plaque can also go in the direction brain, thru carotid arteries which are not in best shape....

My bet- this is more a tactical move, more than anything else. :bang: :bash:

We just have to find out whats really behind this.... :evil:

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When you thought you had it all... 06 Aug 2014 05:00 #1976

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My advice-

When PPS hits 1,50$ or so. Buy a few more

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When you thought you had it all... 06 Aug 2014 05:02 #1977

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I think this is the first time in the existence of this site that I announced a buy recommendation.

It is also the last one :bye:

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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:

When you thought you had it all... 06 Aug 2014 05:54 #1978

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No comment on the buy recommendation until hear detailed explanation on what happened,why ,and future plans. I will comment that in typical Cytori form this announcement was mishandled. They have once again created a panic by putting out a statement and then leaving shareholders to twist in the wind. There should have been a conference call on this simultaneously.

This surely puts a damper on Okyanos opening .

Today should be an interesting /stressful day.

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When you thought you had it all... 06 Aug 2014 07:10 #1979

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Fas....Makes sense if one is working on the Left anterior descending artery...also goes more with my thinking that a ischemic event makes more sense that a hemorrhagic one.

By tactical move are you saying you think the trial was going to fail anyway ?

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When you thought you had it all... 06 Aug 2014 07:26 #1980

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By tactical move are you saying you think the trial was going to fail anyway ?


Yes- they are struggling with enrollment as usual... and question is when they can proceed with a pivotal anyway, not having the funds at present.

Not delivering as promised was a sure thing- for the umpft time :puke:

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When you thought you had it all... 06 Aug 2014 07:37 #1981

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Just as an update-

I do NOT think it would fail because of the technology- the tech is sound. Just setting of priorities and lack of strong partner for cardiac which is urgently needed.

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When you thought you had it all... 06 Aug 2014 07:43 #1982

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So what would be the chances they unblind the data and report what they have so far ?

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When you thought you had it all... 06 Aug 2014 07:55 #1983

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So what would be the chances they unblind the data and report what they have so far ?


Do not have a clue- but my brain tells me, you simply do not do that. That is like "surrendering"- you simply mothball and wait for better times in 6-9 months and peek across to Okyanos to see how they are doing, which procedures are very much controlled by great cardiologists. Lesley in Miami for instance.

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When you thought you had it all... 08 Aug 2014 13:17 #2004

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Fas, once the end of catheter reaches the area of the heart, I'm kind of surprised that it would it be necessary to pull it all the way out again for the next injection. One would think there should be a way to design a catheter that can deliver 15 separate doses with a single insertion. I'm trying to understand the mechanics of the procedure better.

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When you thought you had it all... 08 Aug 2014 13:32 #2005

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WST- join the club with being confused. I had the procedure 4 times (long ago though) and still do not understand.

I get it that there is kind of a shaft with an open end- so through the shaft you can hoist your stuff- cells, stent or whatever to any particular location. And I would think- you would re-locate your shaft to the next spot NOGA tells you to go to and go through the procedure again.

This is all wrong though- since the cardiogist treating Mac told him he had to hoist 200 times for 15 injections. :really:


If you have time - do some research on the web!! I cannot help you.

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When you thought you had it all... 08 Aug 2014 14:58 #2006

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Replace shaft with "guiding wire" and we are probably getting close. :grin:

This PDF is the invention by Kai Pinkernel- former Cytori employee and now since 5 years Head of Clinical Development at Milteyni.

This was designed to replace NOGA and as I know Cytori- they did nothing with it- :cry: :bang:
Attachments:

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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:

When you thought you had it all... 08 Aug 2014 18:16 #2007

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WST, Fas

Just my two cents on the number of trips the catheter has to take for the injections.
It would seem to me that since each cell dose, though containing millions of cells, is actually very small in volume and Given the length of the catheter, say three to four feet,. It would make sense to me that each dose needs to be loaded individually for each injection at the tip.
I would also think running through a guide wire would give it some protection in aggravating a coronary artery and plaque within a artery but at some point the catheter has to emerge to do its job...the actual injections.
Why two hundred trips for 15 injections ? I am at a loss there.
Of course...pure speculation.
But we all are until we here the final causes.

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