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TOPIC: Cartilage Growth in Small Adipose Osteo Knee Study

Cartilage Growth in Small Adipose Osteo Knee Study 14 Nov 2015 15:49 #5489

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I don't know if this study was brought up before.

This small open label study was published last year and met endpoint in high dose. Hard to meet statistical significance in low and medium dose with only 3 patients in each,

Total 18 patients - 3 @ low dose 10,000,000 cells, 3 @ mid dose - 50,000,000 cells. 12 @ high dose 100,000,000 cells. Only difference is the cells were extracted from fat then cultured and that only MSCs are used.

By comparison:

Cytori trial - 30 patients low dose - 20,000,000 cells, 30 patients high dose - 40,000,000 cells 30 patients placebo.

The above trial actually did two arthroscopies (baseline and 6 months) to measure cartilage growth and defect size along with MRIs. this part of the study was blinded to the evaluator. Read for yourself but there was improvement in both, especially in the high dose.

In comparing trials, these are the issues:

1) what is the effect of a cocktail of ADRCs vs. just MSCs
2) what is the effect of culturing on cells at this level
3) The key question that the Cytori trial will answer is regarding dosing - how does the efficacy of 40,000,000 fresh ADRCs compare to 100,000,000 cultured MSCs

BTW, the results were good, especially the high dose and SHOWED CARTILAGE REGENERATION.
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Cartilage Growth in Small Adipose Osteo Knee Study 15 Nov 2015 12:27 #5492

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Thanks WST, very interesting study and no, we have not covered or seen that one before you found it. :yep:

I will postpone having a detailed look at the paper for another day, but can highlight the expectations/similarities to Cytori Cell Therapy to some extent from the latest cytori presentations...

As a note- the key thing on regeneration of the knee obviously is producing or replacing lost cartilage- from what I have read in the past, cells often produced a cartilage which was NOT the "real thing" i.e hyaline cartilage, for which reason scientists often used the term "hyaline like" cartilage, to express their hope that their product produced the real stuff and not weak ineffective cartilage tissue. :whistle:

On the mechanisms of therapeutic action- Cytori has a lot of aces in their hands on the pain side- i.e. very strong anti-inflammatory actions ( including IL-10 expression :woohoo: ) , but also feels that on the trans-differentiation side, results are possible :whistle:


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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:

Cartilage Growth in Small Adipose Osteo Knee Study 15 Nov 2015 16:28 #5493

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Fas, I think you'll find that evidence of cartilage regeneration it's pretty exciting despite what we have heard so often about "fat cells" from Chis C.

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Cartilage Growth in Small Adipose Osteo Knee Study 16 Nov 2015 05:47 #5495

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Fas, I think you'll find that evidence of cartilage regeneration it's pretty exciting despite what we have heard so often about "fat cells" from Chis C.


Yes, I think you are right there- I do have evidence thereof on fat-cell.com, but I am holding off on developing that page until cytori made it "big time" which surely will happen someday :grin:

But on Centeno- Chris is a capitalist and protective of his turf, which is fine. I think he knows better and basically thinks Cytori has a good future but at the same time, he "has" to combat the illegal fat clinics, which I think is OK.

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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:

Cartilage Growth in Small Adipose Osteo Knee Study 16 Nov 2015 06:22 #5496

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On the impact of SVF versus cultured brews, one can - again- check with Arnold. The below is the "latest" Cytori slide on cell composition of SVF..




I think with stating primary and secondary on the slide- importance is not meant, but that the best way to divvy up SVF, you first use the established nomenclature system and secondly refer to specific cell types included in those mixes.

Key here (again- my understanding and theory) - the cultured brews are basically multiplications of the 2% stem cells. I.e. they fish them out since those cells are plastic adherent.

The key thing from a therapeutic perspective to me seems to be the activation of the precursors- the 40% stromal cells- which become active upon injury and "meeting" injured tissue. For that reason I am comfortable in waiting on the outcome´s of any comparison between SVF and cultured brews...

Arnie recently wrote a paper again, which describes this process nicely...the abstract reads as follows:

MSCs: The Sentinel and Safe-Guards of Injury.
Caplan AI1.
Abstract
Mesenchymal Stem Cells (MSCs) were originally named because they could differentiate in a variety of mesenchymal phenotypes in culture. Evidence indicates that MSCs arise from perivascular cells, pericytes, when the blood vessels are broken or inflamed. These pericyte/MSCs are situated on every blood vessel in the body. The MSCs sense the microenvironment of the injury site and secrete a site-specific factor that serve several important reparative functions: First, a curtain of molecules from the front of the MSCs provide a barrier from the interrogation of the over-aggressive immune system. Second, from the back of the MSCs, a different set of bioactive agents inhibit scar formation and establish a regenerative microenvironment. Third, if bacteria are sensed by the MSCs, they produce powerful protein antibiotics that kill the bacteria on contact. Last, the MSCs surround and encyst intruding solid objects like a piece of wood (a "splinter") or other foreign objects. The MSCs act as a combination paramedic and emergency room (ER) staff to survey the damage, isolate foreign components, stabilize the injured tissues, provide antibiotics and encysting protection before a slower, medicinal sequence can be initiated to regenerate the damaged tissue. The MSCs thus act as sentinels to safeguard the individual from intrusion and chronic injury. A societal treatment system has evolved, paramedics and ER procedures, which mirror in a macro- sense what MSCs orchestrate in a micro- sense. Key to this new understanding is that MSCs are not "stem cells", but rather as Medicinal Signaling Cells as the therapeutic agents.

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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:

Cartilage Growth in Small Adipose Osteo Knee Study 16 Nov 2015 08:54 #5498

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That is the same paper in which he touted the allogeneic model and mentioned Mesoblast and Athersys.There is definitely a trend away from autologous. If you recall Caplan said that the medicinal aspects of the cells don't degrade with cultivation just the regenerative properties, at least that is what I recall.

Here is another listed company, CMBG (that has been subject to a nasty SA bear attack), with clinical data on knee osteoarthritis in China:

Technology Platform: Human Adipose-Derived Mesenchymal Progenitor Cells (haMPC)

Trial Phase: Clinical Trial Phase IIb, all patients completed treatment as of August 2014

The Trial . In 2013, we completed a Phase I/IIa clinical trial, in China, for our Knee Osteoarthritis (KOA) therapy named ReJoin™ . The trial tested the safety and efficacy of intra-articular injections of autologous haMPCs in order to reduce inflammation and repair damaged joint cartilage. The 6-month follow-up clinical data showed ReJoin™ therapy to be both safe and effective.

In Q2 of 2014 we completed patient enrollment for the Phase IIb clinical trial of ReJoin™ for KOA. The multi-center study has enrolled 53 patients to participate in a randomized, single blind trial. We published 48 weeks follow-up data of Phase I/IIa on December 5, 2014. The 48 weeks data indicated that patients have reported a decrease in pain and a significant improvement in mobility and flexibility, while the clinical data shows our ReJoin™ regenerative medicine treatment to be safe. We announced interim 24 week results for ReJoin™ on March 25, 2015, which confirmed that the primary and secondary endpoints of ReJoin™ therapy groups have all improved significantly compared to their baseline. We plan to release 12 month follow-up data in late 2015.

Our ReJoin™ human adipose-derived mesenchymal progenitor cell (haMPC) therapy for KOA is an interventional therapy using proprietary device, process, culture and medium:
• Obtain adipose (fat) tissue from the patient using our CFDA approved medical device, the A-Stromal™ Kit; and
• Expand haMPCs using our proprietary culture medium (serum-free and antibiotics-free); and
• formulated for ReJoin™ therapy using our proprietary formulation.

Our process is distinguishable from sole Stromal Vascular Fraction (SVF) therapy.
The immunophenotype of our haMPCs exhibited multiple biomarkers such as CD29+, CD73+, CD90+, CD49d+, HLA-I+, HLA-DR-, Actin-, CD14-, CD34-, and CD45-. In contrast, SVF is merely a heterogeneous fraction including preadipocytes, endothelial cells, smooth muscle cells, pericytes, macrophages, fibroblasts, and adipose-derived stem cells (ASCs).

About Knee Osteoarthritis
Osteoarthritis is a degenerative disease of the joints. KOA is one of the most common types of osteoarthritis. Pathological manifestation of osteoarthritis is primarily local inflammation caused by immune response and subsequent damage of joints. Restoration of immune response and joint tissues are the objective of therapies. According to International Journal of Rheumatic Diseases, 2011, 53% of KOA patients will degenerate to the point of disability.

Conventional treatment usually involves invasive surgery with painful recovery and physical therapy. As drug-based methods of management are ineffective, the same journal estimates that some 1.5 million patients with this disability will degenerate to the point of requiring artificial joint replacement surgery every year. However, only 40,000 patients will actually be able to undergo replacement surgery, leaving the majority of patients to suffer from a life-long disability due to lack of effective treatment.

KOAprocess Our KOA therapy is not surgically invasive – it uses a small amount (30ml) of adipose tissue obtained via liposuction from the patient, which is cultured and re-injected into the patient. The injections are designed to induce the body’s secretion of growth factors promoting immune response and regulation, and regrowth of cartilage. The down-regulation of the patient’s immune response is aimed at reducing and controlling inflammation which is a central cause of KOA. We believe our proprietary method, subsequent haMPC proliferation and processing know-how will enable haMPC therapy to be a low cost and relatively safe and effective treatment for KOA. Additionally, banked haMPCs can continue to be stored for additional use in the future.

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Cartilage Growth in Small Adipose Osteo Knee Study 19 Nov 2015 21:36 #5509

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A must read, especially the part where the doctor brings up the FDA. Here it is. Another great individual bstory about knee pain but these doctors cae getting to be so brazen, it unbelievable!

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Cartilage Growth in Small Adipose Osteo Knee Study 20 Nov 2015 04:40 #5510

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***patient-funded research***

I wish we had some of the above. Skirting the FDA regs is no big deal as they will do little and no penalty when, if ever, they do decide to enforce their own rules. Maybe we got a celase sale out of it...LOL
I guess we should be happy patients in the EU are allowed to pay on their own for scleroderma treatment right now.

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Cartilage Growth in Small Adipose Osteo Knee Study 21 Nov 2015 07:25 #5511

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WST, interesting article which provides further anecdotal evidence of the efficacy of the SVF in OA indications. The FDA has laid out the new directive about "cells being drugs" but appears to be unwilling to enforce it. We do a 90 patient phase two trial in OA costing millions and this anesthesiologist gets to undertake a 250 person, patient funded trial (without placebo). It would be interesting to know what data is provided to the FDA beyond safety ........ probably very little, if any.

The FDA is very knowledgeable about SVF in treating OA type conditions in animals. They know it works and they will give us the approval when the phase III OA trial is completed in humans. Celution provides a validated CGMP.output that addresses the safety concerns of the FDA. Hopefully they will insist that only procedures undertaken with Celution are permissible and that validating the procedure does not mean that reimbursement will be forthcoming for those who do the procedure with alternative tools.

The problem is, when approved how do you control the use of the Celution device?. There is no effective difference in treating scleroderma, fistula, soft tissue wounds or OA which raise the question of how does one control this thing once it is approved and widely distributed? Multiple indications can be addressed without effectively being able to control a differential pricing structure for the different indications.

The SVF treatment procedure is such a radically different treatment paradigm that it also creates/requires a totally NEW and UNIQUE business model that it is hard for conventional providers of health services/products to adjust to. Lets face it, we have an anesthesiologist providing a service that historically would be undertaken by an orthopedic surgeon. That's CRAZY in the conventional context of treating the condition and makes MARKETING the service a real problem for anyone who wants to partner with Cytori, particularly if the same product will be treating a whole range of unrelated conditions ......... not to mention that the SVF output could be produced with alternative methods.

This product may be too good for its own self ............. :bash: :KO: :puke:
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Cartilage Growth in Small Adipose Osteo Knee Study 21 Nov 2015 10:50 #5512

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It would be interesting to know what data is provided to the FDA beyond safety


Rongside, I don't believe for a minute that this outfit is in any way corresponding with the FDA. IMHO, that is probably an outright lie. Also weird about this article is a link for treatment info at the end on a CBS affiliate website. Strange.

Hopefully they will insist that only procedures undertaken with Celution are permissible and that validating the procedure does not mean that reimbursement will be forthcoming for those who do the procedure with alternative tools.



Only an FDA approved device/procedure can get insurance reimbursement. If and when the FDA approves Celution, you can bet that these stem cell clinics will be knocking at Cytori's door as a private pay SVF stem cell clinic cannot compete with a reimbursable procedure with an FDA approved device.

The problem is, when approved how do you control the use of the Celution device?. There is no effective difference in treating scleroderma, fistula, soft tissue wounds or OA which raise the question of how does one control this thing once it is approved and widely distributed? Multiple indications can be addressed without effectively being able to control a differential pricing structure for the different indications.


This is one thing I am not concerned about at all. First of all, software on the celution will control the ADRC output and I beleive it will be optimized based on the application (Fas?). Furthermore, if doctors choose to provide off label treatments, Cytori still gets paid for the consumable.

The SVF treatment procedure is such a radically different treatment paradigm that it also creates/requires a totally NEW and UNIQUE business model that it is hard for conventional providers of health services/products to adjust to. Lets face it, we have an anesthesiologist providing a service that historically would be undertaken by an orthopedic surgeon. That's CRAZY in the conventional context of treating the condition and makes MARKETING the service a real problem for anyone who wants to partner with Cytori, particularly if the same product will be treating a whole range of unrelated conditions ......... not to mention that the SVF output could be produced with alternative methods.


Again, no concerns here for me. Ortho surgeons will still be able to use the celution in their practices and heart surgeons in theirs. You still need to know the anatomy of the body part you are trying to treat and hit the right spot treat a knee or shoulder, for example.

There are things to worry about rongside, specifically the balance sheet. However to the point of obtaining FDA approval,once this occurs ADRC therapy will be an easy sell because PATIENTS will seek it out. I actually saw a new stem cell clinic advertising on my local news station the other night. And just about every disease imaginable was scrolling down the screen as a doctor tried to sell viewers!

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Cartilage Growth in Small Adipose Osteo Knee Study 22 Nov 2015 11:22 #5517

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Rongside :The problem is, when approved how do you control the use of the Celution device?. There is no effective difference in treating scleroderma, fistula, soft tissue wounds or OA which raise the question of how does one control this thing once it is approved and widely distributed? Multiple indications can be addressed without effectively being able to control a differential pricing structure for the different indications.

WST: This is one thing I am not concerned about at all. First of all, software on the celution will control the ADRC output and I believe it will be optimized based on the application (Fas?). Furthermore, if doctors choose to provide off label treatments, Cytori still gets paid for the consumable

.

I do agree with the statement in bold- this is what we have been saying all along since 2009 and I still believe this to be the case. On top of that I think the software code for the centrifugation process will be a better protected = hardcoded than the original MS windows code from the late eighties, beginning nineties. Cause that- yes- is where the key to this issue is hidden.

But first of all- if you look at the slide- Cytori believes there are differences in the therapeutics.... :whistle:



We see 4 product designations- i.e. diversification in the output of Celution or CTX2. And this can be done with "gentle gyrations" of the centrifuge. I personally only have learned about getting the cells in either a neutral, hydrophobic-, or hydrophilic state (water molecule "loving or repellent") and I guess most of this will remain well-guarded Company IP and not be shared in conferences period. :winky: :whistle:

The best thing is to go back to my Celution Versatility article from early 2012 - link : HERE

The 5 minute podcast/audio file is a recording of the CC in 2009 where Hedrick explains this quite nicely. :grin: :nice:

Mind you- although I am useless with Mobile technology , I am pretty fit with what is possible with chip/hardware and internet technology. Cytori will be perfectly capable to control there equipment remotely wherever they are. :cool: :yep:
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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:

Cartilage Growth in Small Adipose Osteo Knee Study 22 Nov 2015 11:44 #5518

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I envision a time when women will get together for celution parties similar to how Botox parties are held now. They'll plump up their lips, enjoy intravenous cocktails of stem cells and every single procedure will be recorded and databased through the Internet.

It will happen.

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Cartilage Growth in Small Adipose Osteo Knee Study 22 Nov 2015 13:10 #5522

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CDG

That would be one long party !!!

I don't see it. :really:

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Cartilage Growth in Small Adipose Osteo Knee Study 23 Nov 2015 12:11 #5528

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Yes, it will definitely happen one day. Later when the technology is even more established I believe there will be so many applications that people will start to look at adipose tissue not as an endless sea of ADRCs but as a valuable resource that is finite. Then people will be a little more cautious and select what they really want to use them for. That'll be the day! Looking forward to it.

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Cartilage Growth in Small Adipose Osteo Knee Study 07 Jan 2016 01:12 #5939

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wall street titan

i found your thread to the topic i posted some weeks later. Sorry for that. :bye:

But it shows good results in cartilage growth.


Good OA results are the value driver for the company.


Holdi

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Cartilage Growth in Small Adipose Osteo Knee Study 07 Jan 2016 07:30 #5940

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Fox,

I completely agree. If we get good OA results then we should be able to get a good partnership deal soon. That would be a huge value driver for the pps imho. I won't be disappointed if they reach a partnership deal for something else first though. Cash is cash.

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Cartilage Growth in Small Adipose Osteo Knee Study 07 Jan 2016 10:26 #5943

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Fox,

No problem. When I saw your post I knew I had brought up the study but I searched and could not find it. It is some of the best evidence that this will work. Growing healthy cartilage is a huge accomplishment.

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Cartilage Growth in Small Adipose Osteo Knee Study 07 Jan 2016 11:19 #5944

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first let the hedge funds taken it down to 0.1$ then we report good results and we go up till 0.2 or even 0.3(200% gain)...they(hedge funds ) made again a fortune and we have a stock at 0.3$...and then again they will start to short it and again again the cyclus will repeat....

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Cartilage Growth in Small Adipose Osteo Knee Study 07 Jan 2016 12:55 #5946

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dis wrote: first let the hedge funds taken it down to 0.1$ then we report good results and we go up till 0.2 or even 0.3(200% gain)...they(hedge funds ) made again a fortune and we have a stock at 0.3$...and then again they will start to short it and again again the cyclus will repeat....



At this point, any excitement would suffice. I wouldnt mind 6 months of day trading triples back and forth

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Cartilage Growth in Small Adipose Osteo Knee Study 07 Jan 2016 15:34 #5948

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** At this point, any excitement would suffice. I wouldnt mind 6 months of day trading triples back and forth ****

but if drops from 10 to 9, you lose 10%

Now what happens if it goes lower?

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