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TOPIC: Stem Cell Processor?

Stem Cell Processor? 24 Apr 2013 17:02 #406

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Solicitation can be found at
www.acq.osd.mil/osbp/sbir/solicitations/sbir20132/army132.pdf


Since Hedrick is cited in most of the reference material it seems logical that Cytori would be a logical player here. Considering the fact that the celution machine already demonstrates the basic technology required. I am not a scientist but it seems that to downsize the footprint of the platform could be done. From what I have read on this site the current celution machine is smaller than the original. Can further changes be adapted to make it small enough to use as a field device? I think that is what the Army wants. In a true clinical setting I don't think the size of the device is as important.

I am not sure if Cytori qualifies as a small business since their market cap is in the hundreds of millions. In any case they could partner with a small lab in order to leverage their expertise and help to develop the handheld processor that the defense department is interested in obtaining. I would be interested to see how Cytori's oft referred to patents would impact any research involving the processing of adipose derived stem cells.

In any event it is nice to know that the government is convinced that regenerative medicine is a viable technology and is willing to invest in its development.

Here is the text of the solicitation.


A13-087 TITLE: Handheld Adipose Stem Cell Processor for Point of Care Application
TECHNOLOGY AREAS: Biomedical
ACQUISITION PROGRAM: Office of the Principal Assistant for Acquisition
OBJECTIVE: Develop a low cost, handheld tool that fully integrates the process from fat tissue harvest to high
quality stem cell product, enabling point of care application of adipose derived stem cell therapy.
DESCRIPTION: Adipose derived stem cells, in particular the stromal vascular fraction (SVF), are attractive for
regenerative medicine applications because of the ease of accessibility, multipotency of the cells, and avoidance of
ethical issues. The current process for extracting, isolating, and processing of adipose derived stem cells has
limitations including processing time and size of the instrument. These limitations also impact the workflow of the
surgeon in providing novel cell therapy for point of care applications. Therefore, development of a handheld tool
that could streamline and integrate the collection and the subsequent processing of adipose lipoaspirate tissue to
result in a sterile, concentrated stem cell product ready for use will enable applications of cell therapy at point of ARMY - 36
care. This SBIR topic seeks for a novel, integrated tissue and cell recovery system for rapid processing and recovery
of desired regenerative cells with cell recovery from 5-20 million, with greater than 75% cell viability, and be free of
fibrous material and cell debris. The solution also needs to address current technology limitations such as sterility
breaks, acquisition and process time, complexity of operation, and cost. Development of this technology should
provide for convenient and rapid extraction of millions of processed regenerative stem cells as a readily available
source of adult stem cells for therapeutic applications to treat diseases and traumas such as Parkinson’s and wound
repair respectively. Solution should take into consideration of the surgeon’s workflow and provide for an ergonomic
design. The process design should not harm cells and provide for the highest number of stem cells recovered,
resulting in a population of quality stem cells readily available for use.
PHASE I: Conceptualize and design an innovative solution that meets the topic’s objective. Required Phase I
deliverables will include concept design, schematic drawings, anticipated performance metrics for the device,
specifications, plans for testing and evaluation for Phase II implementation, and a well-developed business model or
plan for commercialization (this should include estimated manufacturing cost). No animal or human use testing is to
be proposed or executed during this 6-month Phase I period. Cells should be from commercial sources (if from other
methods of procurement requiring institutional regulatory approval, this must already be approved prior to proposal
submission).
PHASE II: Finalize design, development, and demonstration of proposed solution based on results from Phase I.
This includes building a preliminary prototype for testing and evaluating the technical feasibility. The
demonstration of proof-of-concept should confirm and/or establish performance metrics (e.g. cell processing time).
Additional required Phase II deliverables will include design improvements to the prototype, demonstration in an
operational setting, validation of cell extraction using standard assays and/or methods, determination of performance
metrics including processing time and sterility confirmation, and a refined technology transition and/or
commercialization plan including manufacturing and regulatory pathway (also provide an updated manufacturing
cost). Statistical power should be adequate to document performance metrics.
PHASE III: Phase III efforts should lead to 510K clearance or other appropriate regulatory approval and be focused
towards technology transition, preferably commercialization of SBIR research and development. Efforts leading to
510K clearance or regulatory approval require execution of Phase II plans on commercialization and regulatory
pathway. The small business should have in plans to secure funding from non-SBIR government sources and /or the
private sector to develop or transition the prototype into a viable product for sale in the military and/or private sector
markets. Commercialization plans that include the private sector markets generally help lower cost through economy
of scale.
REFERENCES:
1. JM Gimble, AJ Katz, BA Bunnell. Adipose-Derived Stem Cells for Regenerative Medicine. Circulation Research.
2007; 100:1249-1260.
2. S Lendeckel, A Jodicke, P Christophis, K Heidinger, J Wolff, JK Fraser, MH Hedrick, L Berthold, HP Howaldt.
Autologous Stem Cells (Adipose) and Fibrin Glue Used to Treat Widespread Traumatic Calvarial Defects: Case
Report. Journal of Cranio-Maxillofacial Surgery. 2004; 32(6):370-373.
3. PA Zuk, M Zhu, H Mizuno, J Huang, JW Futrell, AJ Katz, P Benhaim, HP Lorenz, MH Hedrick. Multilineage
Cells from Human Adipose Tissue: Implications for Cell-Based Therapies. Tissue Engineering. 2001, 7(2): 211-228
4. MN Helder, M Knippenberg, J Klein-Nulend, PIJM Wuisman. Stem Cells from Adipose Tissue Allow
Challenging New Concepts for Regenerative Medicine. Tissue Engineering. 2007, 13(8): 1799-1808.
5. MB Coelho, JMS Cabral, JM Krap. Intraoperative Stem Cell Therapy. Annual Review of Biomedical
Engineering. 2012, 14:325-349
KEYWORDS: adipose stem cell, cell processing, cell harvesting, regenerative medicine, cell therapy
TPOC: Dr. Eva Lai
Phone: 301-619-2751
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
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Stem Cell Processor? 24 Apr 2013 18:43 #407

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Great info fatboy. The concept of having a compact, mobile celution device is short of brilliant. Cytori has downsized it to a table top device, who is to say it can't be taken one step further?

d9 :nice:

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Stem Cell Processor? 24 Apr 2013 20:12 #408

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I dont see the point of having it actually a hand held device.....I mean table top should be just fine, but perhaps a scaled down version of a table top could be convient. Its not like these guys will be doing this in the actual field of battle and chronic disease can wait another hour for processing. Now, getting the processing time down would be of special value, especially in a acute situation.

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Stem Cell Processor? 25 Apr 2013 10:48 #409

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I agree that the technology required to create a "hand held" device may be a stretch at the current stage of the technology. Especially when you account for the need to harvest, process, and deliver useful explicitly defined cells. All of this in a limited time frame.

What intrigues me as an investor is that a government agency with significant funding perceives the need for a device to administer adrc's. To me that is the driving force behind Cytori.

Consider this:
The efficacy of the treatment has not been successfully demonstrated (at least not proven at the trial level)
Yet the government seems to believe that the science is sound enough to invest in research to develop technologies for the use of adrc's
This thinking is evident in BARDA aggreement as well

It seems to me that the interest in this science by the government must have at its base the fundamental belief in the science of regenerative medicine. And the faith that the use of stem cells will become an important component in the healing process and for other uses not even understood in the regeneration of human tissue.

What we need is a catalyst to get the funds needed to develop this technology.

What that catalyst will be is unknown.

I believe it will come. Soon I hope. This work thing is gettin old...

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Stem Cell Processor? 25 Apr 2013 18:28 #410

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Valid points fatboy but while I am excited by the possibilities of the technology and government funding avenues I think as a endorsement we need to view any government backed entity with a magnifying glass...as example the millions and millions wasted on green energy companies that are now bankrupt and nothing for the government to show for it.

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Stem Cell Processor? 26 Apr 2013 09:47 #411

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Interesting find indeed.

That the army considers having a device as such for its medical work force is of course a confirmation of the fact that it dawns on more parts of society that ADRCs have a lot of potential.

My first thought after reading this was- have a look at the TissueGenesis patent filing on their processing machine- that patent was filed in 2007 and still has not been approved, so I guess it must conflict with the Cytori patent. Reason why? TissueGenesis has been funded by the armed forces to a great extent in the past- so they seem to have the connections there.

Second thought- the IFATS meeting last year definitely concluded that there is only ONE way, to efficiently extract clinical grade cells from fat and that is with enzymic digestion. There is no other effective way- so whatever the army decides it has to come back to Cytori or Tissuegenesis, whereby the patent issue will play a major role.

We will see-

Fatboy- thanks for the DD- your statement-

The efficacy of the treatment has not been successfully demonstrated (at least not proven at the trial level)
Yet the government seems to believe that the science is sound enough to invest in research to develop technologies for the use of adrc's


however does not make sense- listen to what Steve Brozak says in his introduction of Cytori- the science HAS been proven on humans- to get to big money of the BARDA contract they only have to prove that it works in ANIMALS too.
Radiation burns have been treated since 2008 with Cytori technology- Akita in Nagasaki was provided with 30 MIO$ from the Radiation consortium to investigate this therapy. You can test it on a lot of patients with that money.
Just Cytori does not want to tell us apparently.
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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:

Stem Cell Processor? 26 Apr 2013 16:58 #412

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Fas,
Thanks for your reply. I am glad you remarked on my statement regarding the efficacy of the use of adrc's . I admit I was not comfortable with it when I wrote it. What I meant was that Cytori has no US approvals. At least that is what my impression is.

I am relatively new here so forgive me if I am not familiar with many of the nuances of international and domestic studies that have been done, are in the process of being done, or are planned . In the many years of this company there is a vast amount of information. Some good, some not so good. I am sure much of the history of what has occurred exists in the memories of a few only. I am thankful that you take the time to share your investigations on this site. Makes it interesting. Although a higher stock price would be more interesting. In any event thank you for alerting me to Tissuegenesis. I googled the company and now I see what you mean. They have a machine too!

From the Tissuegenesis website

www.tissuegenesis.com/aboutus.html

Adipose tissue continues to generate interest as a preferred source of regenerative stem cells. The stem cells isolated from adipose tissue are abundant, easily extracted via lipo-aspiration, and they are capable of differentiation into numerous cell types. In fact, the stem cells from adipose tissue are found to be equivalent, if not superior to bone marrow stem cells, in terms of cell differentiation (maturation), angiogenesis (new vascular growth) and anti-inflammatory effects. For these reasons, adipose-derived stem cells hold particular promise in the field of regenerative medicine. Large quantities of adipose-derived stem cells may be collected in a single procedure, without the need for cell culture expansion.

Given the inherent advantages of using adipose tissue as a source of regenerative cells, and because current methods of isolating regenerative cells from lipoaspirate specimens are time- and labor-intensive, Tissue Genesis has developed a point-of-care automated Icellator Cell Isolation System™ capable of recovering and delivering tens of millions of regenerative cells in about an hour.
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Stem Cell Processor? 28 Apr 2013 03:26 #413

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Fatboy-

The problem with Cytori is that they have not told many things apparently for COMPETITIVE reasons. Just read the answers by Tom Baker on some the questions from this board and this will become clear.

On top of that- this fact is the main reason why I made this website- to keep shareholders informed of what is MOST likely going on and look into things like the ROBUST trial- which is BIG and IMPORTANT. I think their are many things like that.

On TissueGenesis I wrote an article on this site also analyzing the competitive situation with them-

TissueGenesis researched
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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:
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