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TOPIC: BARDA data?

BARDA data? 22 Apr 2015 09:57 #4319

  • CalhounDoppelganger
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Is this abstract up to date? (if so it looks good to me)

www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e752e0e6-8276-4926-aa40-0cc3a2b5e0c9&cKey=a7df1c71-1600-494e-9581-a6e84f9af6c7&mKey=%7B71D9A9F0-A27E-4F56-8DF3-AB7E39E05F96%7D


Results: Results show that this model adequately reflects the status of a patient with thermal burn and radiation exposure likely to be triaged to receive care following a mass casualty event. All animals exhibited substantial myelosuppression. The results also demonstrated that ADRC delivery treatment (local and IV) have the potential to increase epithelialization, increase collagen deposition and to exert an immunomodulatory effect in vivo.

Conclusions: We describe standardized procedures to create a reproducible porcine model of concomitant radiation and burn injury that can be used to evaluate potential therapeutic interventions.

Applicability of Research to Practice: This model may facilitate the study of combined radiation and burn injury and accelerate the development of new countermeasures to be deployed following a mass-casualty event involving detonation of an Improved Nuclear Device

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BARDA data? 22 Apr 2015 16:50 #4327

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IMO, according to prior use of "Improvised Nuclear Device," that's what they meant by "Improved Nuclear Device"; otherwise, yes, that's what one of the Abstracts read

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BARDA data? 23 Apr 2015 07:24 #4330

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Surely "improvised" is correct, when the reference is to a terrorist attack with a nuclear device. :grin:

Anyway- the announcement of what we largely already discussed in 5 threads..

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) presented data from two preclinical studies funded through its contract with the United States Biomedical Advanced Research and Development Authority (BARDA) at the 2015 American Burn Association Meeting this week in Chicago. The findings provide greater detail as to how Cytori's cellular therapeutic improves healing following thermal burn injury even in subjects with substantial radiation exposure.

"Our data show that Cytori Cell Therapy acts at the cellular and molecular level to modulate different phases of wound healing thereby accelerating wound closure in clinically relevant large animal models. Treatment led to increased angiogenesis, blood vessel maturation, and deposition of collagen matrix which, along with accelerated epithelialization led to faster repair," said Dr. John Fraser, Chief Scientist of Cytori Therapeutics. “These data are consistent with our prior studies with cells derived from adipose tissue in situations involving ischemia, inflammation and fibrosis.”

The first presentation titled “Autologous Adipose-Derived Regenerative Cells (ADRCs) Enhance Wound Healing in a Minipig Model of Concomitant Radiation and Thermal Burn Injury” establishes in a preclinical model that Cytori Cell Therapy may be a safe and effective means for improving burn wound healing in the context of concomitant radiation exposure. This model comprises radiation exposure sufficient to damage the bone marrow combined with full thickness burn injury. This is the first reported large animal model reflecting the clinical situation of patients exposed to both thermal and radiation injury following detonation of an improvised nuclear device.

Results demonstrate that delivery of Cytori Cell Therapy accelerated wound healing with an average 67% increase in blood vessel density, 30% increase in matrix (collagen) deposition, and a 3.5-fold increase in epithelialization two weeks after treatment (compared with control wounds). In addition, molecular analysis demonstrated a 4-fold increase in E-cadherin expression (a marker of epithelialization) in cell-treated wounds. Importantly, similar results were observed when the product was injected directly into the wound or, using a modified formulation, by intravenous administration. Dr. Dunstana Melo, Director of the Center for Countermeasures Against Radiation at Lovelace Respiratory Research Institute (LRRI) noted that, “The knowledge obtained with the referred model will accelerate the assessment of new medical countermeasures to be deployed following a mass-casualty event involving detonation of an Improvised Nuclear Device”.

The second poster presentation titled, “Autologous Adipose-Derived Regenerative Cells (ADRCs) Seeded in Collagen Scaffold Improves Dermal Regeneration, Enhancing Early Vascularization and Structural Organization Following Thermal Burn Injury," shows that seeding the Cytori cell therapy product onto a widely used dermal substitute after full thickness burn injury increases depth of wound tissue, collagen deposition, and wound tissue maturation. Specifically, histological analysis revealed that blood vessel density was increased by 50% in wounds receiving cell therapy compared to control. Similarly, the number of aSMA-positive vessels increased by 60% compared with control. This quantitative and qualitative improvement in vascularity was associated with 2-fold increase in tissue thickness and 1.7-fold increase in collagen I deposition within the wound bed. In addition to these improvements in wound healing parameters, addition of the cell therapy product to the scaffold did not impair the ability of the scaffold to resist wound contraction. Wound contraction is a precursor to the development of burn scar. One of the functions of the collagen scaffold is to resist contraction. The data showed no relevant difference in wound contraction between treated and untreated wounds, which can be considered supportive of the safety of the cell product. These data demonstrate that the delivery of the cell therapy product along with skin substitutes creates the potential for earlier application of autologous skin grafts thereby reducing patient hospitalization, recovery time, and outcome following severe thermal burn. “These are important findings providing new insights for combination of Cytori Cell Technology with engineered biomaterials for wound healing in severe burn patients,” said Dr. Mayer Tenenhaus, plastic surgeon at UCSD Burn Center, specializing in surgery for burns and other traumatic injuries.

Presentations Details:
Abstract #268
Title: Autologous Adipose-Derived Regenerative Cells (ADRCs) Seeded in Collagen Scaffold Improves Dermal Regeneration, Enhancing Early Vascularization and Structural Organization Following Thermal Burn Injury
Presenter: Philippe Foubert
Poster: P17. Wounds – Translational Science I
Link: www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e752e0e6-8276-4926-aa40-0cc3a2b5e0c9&cKey=ca9c9a72-946f-4fb7-81a1-7e178df8f16a&mKey=%7b71D9A9F0-A27E-4F56-8DF3-AB7E39E05F96%7d

Abstract #273
Title: Autologous Adipose-Derived Regenerative Cells (ADRCs) Enhance Wound Healing in a Minipig Model of Concomitant Radiation and Thermal Burn Injury
Presenter: Philippe Foubert
Poster: P17. Wounds – Translational Science I
Link: www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=e752e0e6-8276-4926-aa40-0cc3a2b5e0c9&cKey=a7df1c71-1600-494e-9581-a6e84f9af6c7&mKey=%7b71D9A9F0-A27E-4F56-8DF3-AB7E39E05F96%7d

Abstracts are currently available on the American Burn Association website at www.ameriburn.org/47thAnnualMeeting.php

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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:

BARDA data? 23 Apr 2015 07:36 #4331

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Interesting this particular line:

In addition, molecular analysis demonstrated a 4-fold increase in E-cadherin expression (a marker of epithelialization) in cell-treated wounds. Importantly, similar results were observed when the product was injected directly into the wound or, using a modified formulation, by intravenous administration.


Meaning- the cells find their way to the site of injury (as we always expected from Caplan theory) and do not stay in the lungs. I presume similar "cell count" was used for local versus systemic treatment. :grin: :vegas:

As a reminder to folks who think this is impressive- just look at examples from Akita on humans inclusive the one a wound of a 87 year old lady- that is a lot more impressive and represents the power of the technology. I never understood why wound healing never has been marketed in Europe- but that is just one aspect what I do not understand about cytori and I guess I will never learn... :cry:

Link to article: ADRCs- holy grail for wound healing

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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:

BARDA data? 23 Apr 2015 08:15 #4334

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Intravenous! First time that I think I heard that a CYTX trial tried intravenous. Okyanos has been so I think this could be an important advance.

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BARDA data? 23 Apr 2015 08:50 #4337

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Fas....what do you think about treating a burn patient in the traditional manner but also receiving a ARDC IV treatment at bedside.
Many short procedures are done at bedside nowadays and it wouldn't tie up valuable O.R. time.

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BARDA data? 23 Apr 2015 09:23 #4340

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what do you think about treating a burn patient in the traditional manner but also receiving a ARDC IV treatment at bedside.
Many short procedures are done at bedside nowadays and it wouldn't tie up valuable O.R. time.


Of course, these things need to be tested before anybody can make a sensible statement on the question, but my best guess would be that 1+1 does not make 2 here, but still either administration pathway brings the same result. :whistle:

Same thing as Centeno says- ADRCs plus his BM dose in "broken" knees does not give better results as his BM dose only. Same thing with ADRCs plus rhBMP2 which work on their own quite nicely but do not perform better in combination.

Probably due to threshold issues we discussed many years ago- and the fact that the paracrine mechanism of inputted cells rely on the number of available endogeneous cells, which they can influence. More cells simply becomes an overdose which remains ineffective.

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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:

BARDA data? 23 Apr 2015 09:56 #4341

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Of course....this would need to be proven thru trial to market in this manner but I was think more along the lines of a reduction or even elimination in the number of grafts that do not take. Severe burn injuries require many surgeries....a reduction in this number can be of great benefit in cost let alone patient suffering and recovery time.

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BARDA data? 24 Apr 2015 08:13 #4345

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Does anyone else find it strange that the FDA has fast tracked the Scleroderma trials, but the fully funded BARDA contract for thermal burn injury will take phase II and phase III trials to gain approval. Both indications are roughly the same patient population of around 50,000. Evidence of efficacy is ample for both. Remember, Cytori won the BARDA contract because of all of the evidence accumulated from breast reconstruction in women who has radiation damage from their cancer treatment. Cytori proved it worked in humans, then they had to go back and start all over with pre-clinical trials on animals so they could fit into the "process" of animals first, then humans. If anything deserves fast tracking, it should be thermal burns.

Lots of metrics presented in Chicago showing the cells work and work very well. Still, nothing works better than photographs. Some day there will be two people burned badly in a house fire. One will get only the standard of care and the other will get the SOC plus ADRCs. When the photographs come out showing the difference in how each healed, I will personally pay to put them on the front page of every newspaper and magazine and pressure the FDA into immediate approval. Hope that won't be necessary because it sounds expensive! :KO:

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BARDA data? 24 Apr 2015 08:25 #4346

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DOV...has Cytori asked for a Fast Track for the burn indication ?

Otherwise....no real treatment for scleroderma vs long standing and improving treatments in burns. Breakthrough Designation may be a better first choice. Still, I believe one must apply.

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BARDA data? 24 Apr 2015 08:43 #4347

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BARDA data? 24 Apr 2015 14:26 #4352

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DOV wrote: Does anyone else find it strange that the FDA has fast tracked the Scleroderma trials, but the fully funded BARDA contract for thermal burn injury will take phase II and phase III trials to gain approval. Both indications are roughly the same patient population of around 50,000. Evidence of efficacy is ample for both. Remember, Cytori won the BARDA contract because of all of the evidence accumulated from breast reconstruction in women who has radiation damage from their cancer treatment. Cytori proved it worked in humans, then they had to go back and start all over with pre-clinical trials on animals so they could fit into the "process" of animals first, then humans. If anything deserves fast tracking, it should be thermal burns.

Lots of metrics presented in Chicago showing the cells work and work very well. Still, nothing works better than photographs. Some day there will be two people burned badly in a house fire. One will get only the standard of care and the other will get the SOC plus ADRCs. When the photographs come out showing the difference in how each healed, I will personally pay to put them on the front page of every newspaper and magazine and pressure the FDA into immediate approval. Hope that won't be necessary because it sounds expensive! :KO:



All just formality. If it adds another year to final FDA approval then I am patient. Cytori's proprietary equipment will be standard care in all burn units across the world. That is enough for me. To quantify revenue- just look at radiation treatments correlated with cancer treatments. At the end of the day cancer will never go away because there's just too much money at stake. Between all the aluminum in deodorant and industrial carcinogens, radiation treatments will continue to flourish. As such, Cytori just conquered the cancer market. Unfortunate to say for the uniformed, but the reality is that sound you just heard is simply the cash register ringing up sales.......

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BARDA data? 03 May 2015 20:38 #4401

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Calhoun Dop.........Your post is in my top 5 favorite posts of 2015 , may be 2014 as well......right on - forgot

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