Welcome, Guest
Username: Password: Remember me
Cytori´s Platform applications
  • Page:
  • 1

TOPIC: So far- only safety data on 23 ADVANCE patients

So far- only safety data on 23 ADVANCE patients 17 Nov 2014 10:00 #2692

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115
Are they pulling our legs again?

Objectives: The ADVANCE clinical trial sought to define the safety, feasibility and efficacy of an intracoronary infusion of adipose derived regenerative cells in patients admitted with an acute ST-elevation myocardial infarction (STEMI) within 24 hours of successful primary PCI.
Methods: In this randomized, double-blind, placebo-controlled trial (n=23, 2:1 randomization), within 24 hours of successful primary PCI following STEMI, a small volume liposuction was performed for fat harvest and ADRC isolation by an automated Celution® System, and intracoronary infusion within 12 hours of the liposuction.
Results: 23 patients were enrolled to date (all male, age 58 years, BMI 28 kg/m2). The liposuction procedure data are shown in the table
STEMI patients were routinely treated with dual anti platelets and heparin. The decline in hemoglobin following the liposuction procedure from baseline over the 10 hours following the procedure was 10.2% ±7.6 (mean±SD) Although two patients had >20% of Hb decline at anytime (maximum 20.8%), one of these patients returned to within 10% of baseline by 10 hours without transfusion. The liposuction procedure was completed in all but one patient (terminated early due to hypotension - resolved with termination of procedure).
IC infusion of the ADRC suspension was performed successfully in all patients. No impediment of coronary TIMI flow was observed during or following cell infusion of these mesenchymal-like cells. No ventricular arrhythmias were observed during cell infusion. No major adverse cardiac or cerebral events (MACCE) occurred within 30 days of the procedures.
Conclusion: Limited liposuction to harvest fat for ADRC stem cell isolation and subsequent intracoronary infusion of these autologous ADRCs can be performed safely in patients with acute STEMI under dual antiplatelets therapy, demonstrating feasibility of the therapeutic application of point-of-care cell therapy using ADRCs.


Please Log in or Create an account to join the conversation.

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:

So far- only safety data on 23 ADVANCE patients 17 Nov 2014 13:00 #2695

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2825
  • Thank you received: 202
Could be up a whole penny by the close...LOL !

Will 31 ATHENA patients really change our fortunes ? :bang:

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 17 Nov 2014 13:03 #2696

  • agamemnus
  • agamemnus's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 155
  • Thank you received: 9
As far as I can tell, no efficacy data is forthcoming per Q2 2013 ER. But, I only saw the abstract and not the full paper, so there may be hints of efficacy in the paper? Is there a place where we can see the actual paper?

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 17 Nov 2014 15:09 #2697

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2825
  • Thank you received: 202
Nope...couldnt even hold one shiny penny.

Up $ 0.0076

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 17 Nov 2014 18:21 #2701

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
NBS appears to be slaughtered AH. The big NBS study does not seem to meet the primary objectives. Maybe CYTX is smart to do what they are doing right now.

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 17 Nov 2014 20:10 #2702

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2825
  • Thank you received: 202
NBS did get hit AH.
Touting their safety profile but mixed on the endpoints.
Not sure if I will listen to their call but it would be interesting to hear what is said.

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 09:43 #2709

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
ADVANCE is celution's application in acute MI, which is always a difficult area to evaluate for both safety (patients selection is difficult) and efficacy (patients need acute care).

While the number of patients is so small, demonstration of safety is still considered good. Data should be useful for the Chinese FDA filing and for use by Okyanos.

I think celution's usage in chronic MI should be better choice. Just my opinion.

NBS is also using two dose levels for stem cells (we are doing the same in Athena 1 and 2, as well as in the pending OA study).

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 10:01 #2711

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115

Data should be useful for the Chinese FDA filing and for use by Okyanos.


Data should in the very first place be useful for shareholders in order to be able to make an assessment of the value of the technology for this application. We do have many videos from Duckers and Calhoun reporting enthusiastically on 14 patients (APOLLO). From that perspective it is unacceptable to be left in the cold on efficacy data on ADVANCE.

Lipo safety has been sufficiently proven in surely over 7-8.000 patients. The lipo safety in patients who are taking coagulants and are in bad health, ditto but the numbers are not that big.

I find this very very disappointing.... and also could use other terms, which I will refrain of here. :evil:

Please Log in or Create an account to join the conversation.

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:

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 10:17 #2712

  • Wall Street Titan
  • Wall Street Titan's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 889
  • Thank you received: 148
They have the efficacy data:

“Although conclusions from the study are limited by the relatively small sample size, it appeared that small volume fat harvest for ADRC preparation and subsequent intracoronary infusion is feasible and can be performed with an acceptable safety profile in patients with acute STEMI under dual antiplatelet therapy,” said Dr. Steven Kesten, Chief Medical Officer. “This finding is consistent with that found in the previously reported APOLLO trial. Data collection of the one year outcomes has been completed and will be discussed in a future meeting or communication.”

Not sure why they are holding it back for future dissemination.

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 10:35 #2713

  • Wall Street Titan
  • Wall Street Titan's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 889
  • Thank you received: 148
Probably because it didn't show anything which is not surprising since the original recruitment was to be over 200 patients and only 23 were treated. Another black hole of wasted money.

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 11:50 #2716

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115

Data collection of the one year outcomes has been completed and will be discussed in a future meeting or communication.”


This is really quite astonishing- cardiac therapy with cells is known to have its major impact in the first 6 weeks to 3 months. This makes the 6 months data very important and the question really has been whether the intermediate results are sustained beyond that point.

That has been the case with PRECISE and APOLLO at 12 and 18 months and in many cases NOT SO in competing BM based clinics.

It beats me what Cytori is trying to achieve here-

The CC was very good- clear and concise with plenty of information. Now we seem to be heading back into the gigantic "black hole" which Cytori is- especially as long as the question list remains unanswered.

Please Log in or Create an account to join the conversation.

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:

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 12:17 #2718

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2825
  • Thank you received: 202
I guess they wont be relying solely on safety data for ATHENA :grin:

Funny they scheduled they vote on the Sabby et al deal BEFORE we get this data.

The Greeks had 300 Spartans...we will rely on 31 ATHENA patients !!!! :really:

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 15:18 #2721

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115
Even if Cytori refuses to communicate to shareholders results of clinics that those SH have paid for, some scientists provide some insight in the mechanisms of action of ADRCs in STEMI.

This was reported by Marco Harmsen of the University in Groningen at IFATS:

In vitro and in experimental animal models for cardiac disease, the paracrine action of ADSC is most prominent – they secrete a host of soluble factors that support angiogenesis, suppress apoptosis and inflammation and improve remodeling. In addition, ADSC acquire a juxtacrine role in repair by virtue of their differentiation to pericytes and smooth muscle cells (SMC) and engaging close contact with small vessels. It is confusing that pericytes, SMC and myofibroblasts are virtually indistinguishable, yet their role in cardiac repair and fibrosis is like Yin and Yang. Limited studies have shown that ADSC promote may suppress myofibroblast formation. Together with their well-established anti-inflammatory features, the ADSC would be the ideal cell to suppress cardiac fibrosis. However, neither animal studies nor clinical trials have provided solid evidence for this presumption as yet. Nevertheless, ADSC do markedly improve post-aMI myocardial remodeling. Clinical trials with ADSC such as APOLLO show that infarct size is smaller after treatment. The final verdict on the use of ADSC for cardiac therapy is not out yet and requires a better understanding of mechanisms on the one hand and optimized delivery and retention strategies on the other hand.

Please Log in or Create an account to join the conversation.

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:

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 15:54 #2722

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2825
  • Thank you received: 202
Exactly Fas....these comments say it all.....we have PROVEN.nothing and this is our problem.

Millions wasted...Years wasted. :cry:

CYTX is not at $ 0.44 give or take for no reason. Our new CFO is not projecting zero to minimal 2015 revenue growth for no reason.

We are basically a cash starved start up as we reset the company and the path forward is very cloudy.

Future = Nitch player until PROVEN otherwise. :evil:

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 17:05 #2724

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
Actually, I found the company PR " interesting", somewhat different from the past, when most of the study findings are biased to the positive side.

This PR highlights two potential problems for treatment in acute MI: hypertension and then dropout in one patient (probably not treatment related; so this patient condition may now go into future exclusion criteria); 20 % drop in hemoglobin in some patients with recovery in one week, with one exception (10 % drop after one week).

The drop in hemoglobin is actually a significant event, probably due to blood loss in liposuction. Of course, this is not life threatening, but I think this is significant, because of the nature of the patients.

I think CYTX has been forthright in the PR, without hiding these clinical events, as in the past. But, then, why? In my opinion, I think the company is trying to sideline the cardiac r/d, leaving future endeavor to sophisticate outfits like Okyanos. I am not sure physicians in China can really perform up this level of sophistication.

I my opinion, future development of stem cells/CD34 in cardiac patients for companies like NBS and Mesoblast (? the Australian company), ASTM, etc. is cloudy. The path is very, very expensive and the outcome may be very uncertain. I think CYTX is aware of these problems and the company is getting out of the race, when Calhoun told us out of the blue that a new study in hamstring injury would be started. In the YouTube video early this year, Calhoun says cardiac studies are too complicated.

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 18 Nov 2014 22:03 #2725

  • agamemnus
  • agamemnus's Avatar
  • Offline
  • Expert Boarder
  • Expert Boarder
  • Posts: 155
  • Thank you received: 9
The abstract title (before the release) didn't say anything specifically about efficacy, but Q2 2013 ER did hint at it. Re-reading the Q2 2013 ER, it does look like they were expecting to publish at least some efficacy data.

Our decision to conclude ADVANCE is based on several considerations. Each country in Europe interprets and implements GMP requirements in a unique fashion. Satisfying this disparate and evolving requirements is proving to be more challenging and costly than anticipated.

Furthermore, certain European regulatory authorities and institutional review boards have rendered mixed opinions on approving the trial with a placebo control arm, a key factor in showing scientifically valid efficacy in this trial. In short, the overall fluidity and lack of standardization in the regulatory environment in Europe around device-based cell therapy in clinical trials will continue to make it increasingly difficult to forecast and manage associated costs and resources. Management will focus internal and financial resources on the highest clinical development priority, which is the expanded U.S. ATHENA trial.

We expect additional safety and efficacy data to be obtained from the continued follow-up of the ADVANCE patients, which will serve to further strengthen Cytori's overall cardiac clinical data. We want to thank all of the patients who have participated in the ADVANCE clinical trial, as well as all of the physicians, investigators, nurses, trial coordinators, technicians, PROs, core laboratory teams, advisory board members, Cytori employees and all the others who have worked so hard in the development and execution of this clinical trial. It takes an incredible effort by many talented people to bring a trial such as ADVANCE to life.


This part of today's press release is interesting. There MIGHT be a chance they will test for efficacy.

"Data collection of the one year outcomes has been completed and will be discussed in a future meeting or communication.”


NBS today showed that even with a few hundred patients, looking for efficacy is a dangerous proposition... and Cytori has two dozen patients only. Then again, CYTX float is already about (edit) 16% shorted.. can't get much worse... can it?

Please Log in or Create an account to join the conversation.

So far- only safety data on 23 ADVANCE patients 19 Nov 2014 09:06 #2727

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115
Franshei- you state

The drop in hemoglobin is actually a significant event


I really do not see it that way. You HAVE to control it since the belly is highly vascularized and anemia can occur, but you simply treat it with a transfusion if that is the case. An on average 10% loss is NADA (normal range 12.5 to 16 gm/dL for elderly males) in the thick of things and as stated if somebody drops by 20%, you still can wait for 10 hours for the value to come back in normal range. :whistle:

With the hyPOtension patient the "stop" of the procedure is OK. Thats extremely low BP and states of shock are always dangerous.

I do not see this as "material" information, but maybe it explains in general why patients do not want cells from fat. It really is not dangerous but simply a very unpleasant experience apparently and maybe doctors are honest about that and scare patients. Centeno always was very negative about lipo´s. Than again I believe, if done the right way- Okyanos specially hired an expert (dr. Todd Malan) for it- things might be different.

Please Log in or Create an account to join the conversation.

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:
  • Page:
  • 1
Time to create page: 0.160 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites