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April 13 2016 is the date of the public hearing, which is of extreme importance for the future of Cytori as a Company. It will likely also determine whether Cytori is "partnerable" or not.
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TOPIC: The Scope of Unapproved US SC Treatment Centers

The Scope of Unapproved US SC Treatment Centers 02 Jul 2016 05:08 #7365

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We have been writing about this for many years and seeing it grow like cancer cells...

Paul Knoepfler and Leigh Turner did more specific "internet research" and published a paper in Cell Stem Cell...

Medical News Today did an article on the issue..

At least 351 companies across the United States are marketing unapproved stem cell procedures at 570 individual clinics. Such businesses advertise "stem cell" interventions for orthopedic injuries, neurological disorders, cardiac diseases, immunological conditions, pulmonary disorders, injured spinal cords, and cosmetic indications. In Cell Stem Cell, bioethicist Leigh Turner and stem cell researcher Paul Knoepfler present an analysis of U.S. businesses engaged in "direct-to-consumer" marketing of these procedures.

"In almost every state now, people can go locally to get stem cell 'treatments,'" says Knoepfler, of the University of California, Davis, and Shriners Hospital For Children. "Many people in larger metropolitan areas can just drive 15 minutes to find a clinic offering these kinds of services instead of, say, traveling to Mexico or the Caribbean. I think this reflects a change from what we've seen documented in the past and is different from what we typically think about when we think of stem cell tourism."

Turner and Knoepfler found the businesses through Internet key word searches, text mining, and content analysis of company websites. For each business, the duo recorded the company name, location(s), website addresses, advertised stem cell types, and marketing claims concerning diseases, injuries, and conditions for which stem cells are reportedly administered. Their research should serve as a baseline for future studies of U.S. businesses engaged in direct-to-consumer advertising of purported stem cell interventions.

Key findings from the report include:
Clinics advertising stem cell interventions cluster in particular states. They are most likely to be found in California (113 clinics), Florida (104), Texas (71), Colorado (37), Arizona (36), and New York (21).
Beverly Hills is home to 18 clinics, more than any other city in the nation, followed by New York (14 clinics), San Antonio (13), Los Angeles (12), Austin (11), Scottsdale (11), and Phoenix (10).
Of the stem cell procedures that are marketed, 61% of businesses offer fat-derived stem cell interventions and 48% offer bone-marrow-based treatments. Advertisements for induced pluripotent stem cells (1 business), embryonic stem cells (1 business), and xenogeneic products (2 businesses) are rare.
Over 300 of the businesses market interventions for orthopedic issues. Other advertised conditions include pain (150 businesses), sports injuries (90), neurological diseases (80), and immune disorders (75).

"This is a marketplace that is dramatically expanding before our eyes - we were aware early on and tracked it early on, but I don't think we knew the scope and size of the market," says Turner, of the Center for Bioethics at the University of Minnesota. "Brakes ought to exist in a marketplace like this, but where are the brakes? Where are the regulatory bodies? And how did this entire industry come into being in a country where stem cell-based interventions and the medical devices that produce them are supposed to be regulated by the FDA?"

Turner and Knoepfler, who runs the popular stem cell blog "The Niche," grew suspicious of an increase in American stem cell clinics when inquiries from readers and patients changed from Americans asking about going abroad for a stem cell treatment to Americans asking about seeking treatment in the United States. In investigating the people who run these clinics, Turner and Knoepfler found that not only were individuals such as cosmetic surgeons and naturopaths beginning to offer unapproved stem cell interventions, but the "pioneers" in the industry were training others to do the same. It is unclear whether federal authorities--particularly the Food & Drug Administration - and state medical boards missed the scope of the problem or are taking minimal action despite being aware of the spread of such businesses.


read full article here : MNT article

Where the hell is the FDA?

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The Scope of Unapproved US SC Treatment Centers 03 Jul 2016 09:30 #7368

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Fas,

In my opinion, these doctors do not believe the FDA has the authority to regulate the practice of medicine. I can't say how many of them are aware the FDA changed the wording of their charter to give themselves authority over stem cells removed from a patient and then injected into that same patient in the same procedure. It is what it is and the FDA has clarified and reiterated their authority and the courts have upheld their authority.

The FDA does not have the funds or personnel resources to enforce their own rules. It is MY opinion, the best way to ensure safety of these procedures is to approve the Celution device for multiple, but specific applications supporting full insurance reimbursement. This would shut down illegal stem cell clinics fast using pricing as the killer. I can't help but correlate this situation with Roe v Wade where the primary concern was safety.

I also believe the FDA wants to approve a stem cell procedure as soon as their trial criteria has been met. No question Cytori has the lead in scleroderma, but I think their lead in OA is fading if they ever had the lead.
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The Scope of Unapproved US SC Treatment Centers 03 Jul 2016 12:01 #7371

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Dov, if everything we have been told about BARDA is not complete bull shit, then the be would think that is where we had the "lead". Supposedly Cytori has been working in step with the FDA. Not much being said about BARDA anymore so I suppose that indication will fade into the sunset along with every other hope and dream. Cytori's definitely never had the lead in OA, so all hope lies with Sceloderma. Time is no longer our friend that ship sailed.
Slowly watching my investment disappear.

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The Scope of Unapproved US SC Treatment Centers 03 Jul 2016 19:30 #7372

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I think DOV is right re OA and I think CYTX's strategy is sailing the company solo, with scleroderma as the main focus in the US, while some other niche indications will be pursued in due course. This is very much OSIR has done.

I think CYTX will be successful with this clinical r/d scope in the US, while growing its commercial activities in Japan/Asia, as well as EU. The company will remain small, but efficient.

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The Scope of Unapproved US SC Treatment Centers 04 Jul 2016 08:31 #7373

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@DOV
@fas

The FDA does not have the resources available to combat these rogue stem cell clinics because the FDA is too preoccupied outlawing companies that sell walnuts:

www.dailymail.co.uk/news/article-2018807/Walnuts-DRUGS-FDA-makes-bizarre-claim-seller-says-reduce-risk-heart-disease-cancer.html


Can't make this stuff up.

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The Scope of Unapproved US SC Treatment Centers 04 Jul 2016 09:22 #7374

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DOV wrote: Fas,

No question Cytori has the lead in scleroderma, but I think their lead in OA is fading if they ever had the lead.


I will take the last remark first, since I just finished some research on the subject.

If you query clinicaltrials.gov on "Cells" and Condition "Osteoarthritis" you get about 120 results- that was too much to check through, but I believe Centeno with his uncultured BM cells can do the job for Grade I maybe II OA. There is some interesting auto BM Spanish stuff- but do not believe allo cells will do the job here.

With "Adipose & Cells" and condition "Osteoarthritis" one gets 26 results. I went thru those in detail. Most is Asian work being done or finished- mainly Korea and Taiwan. The bulk are really those US clinics that Knoepfler is talking about, who put out an IRB and that is it. No contacts with the FDA period.

Only Cytori has under Health authority : FDA, IRB and DSMB- so I see Cytori in front there and really no one else with fat cells.

Of course- everybody can check for themselves : Query
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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:

The Scope of Unapproved US SC Treatment Centers 05 Jul 2016 08:19 #7377

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FAS

Question for you:

If the FDA would enforce their own regs and close down many of these illegal stem cells clinics (marketing unapproved therapies), what do you think the impact would be for CYTX? Hedrick did mention before in one of CCs that, it would be a big WIN for the company - but nothing has yet happened.

My impression is: people may group all stem cells r/d companies in the same camp (without knowing the differences between apples and oranges) and casting negative impression on all entities, including OSIR, CYTX, MESO, ATHX, BTX etc Maybe this is the reason that the whole stem cells r/d is out of favor.

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The Scope of Unapproved US SC Treatment Centers 05 Jul 2016 12:15 #7378

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franshei wrote: FAS

Question for you:

If the FDA would enforce their own regs and close down many of these illegal stem cells clinics (marketing unapproved therapies), what do you think the impact would be for CYTX? Hedrick did mention before in one of CCs that, it would be a big WIN for the company - but nothing has yet happened.


Franshei-

Lets be fair- but the FDA regs never have been clear and always were open for abuse. Osiris still is an excellent example- they got rid of prochymal et al- i.e. the allo stem cell product which is clearly a drug, to start business with biologics which they simply claimed were non-regulated products- the 361 products. Of course there are no such things as marketable 361 products- except PRP - and same day processed Bone Marrow procedures a la Centeno.

The last ones are clear- fat never was unless you put in an RFD- a Request for Designation on the FDA´s desk. Cytori did so and so did Centeno for ortho and Ricardo Rodriguez for cosmetic. I am sure all those 500+ fat processing units out there, know as much as I do, but simply act as if their nose is bleeding... i.e. do not WANT to know, before the FDA has its rules established clearly and that process is underway.

As you might know- September 12 is the (postponed) public hearing : Public Hearing- Sept 12

After the rules are law- maybe in a year or so- they ought to act with force - i.e. substantial penalties against leaders of the pack, to drive adherence.

To me- especially since you hear so little about calamities or patients dying, you have to figure everything with fat is extremely safe, so enough PR will be made for people to want to get treated especially when reimbursed.

For Cytori it will mean they become partner-able in the US- surely nobody in his right mind will commit before "cheap competition" has disappeared. So - I agree with Hedrick it will be extremely important and Cytori being the clear leader, but not alone....

TissueGenesis- with ED- and PAD clinics and the GID Group (OA) work with the FDA too and will compete with Cytori to treat patients for off-label use.
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The Scope of Unapproved US SC Treatment Centers 17 Sep 2016 07:52 #7678

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FAS, re FDA pending new stem cells regs and the 500 plus stem cells clinics.

I do not think the FDA can effectively shut down all the illegal clinics in the US. Why?

Many plastic surgeons can still do liposuction and transplant one part of the body to another part of the body, legally, as long as there are 1. no death; 2. serious side effects, 3. patient's own pay, etc. I think the plastic surgeons will continue to process their stem cells samples using ordinary centrifuges.

However, specialized stem cells clinics with therapeutic intents to treat their patients will face major FDA actions, unless they have FDA approval (such as a physician IND for experimental uses of their "products" or "procedure". Using this route, it is pay (by patients) for treatment and this has been done before in by oncologists. Advertisements by these clinics would be closely monitored by the FDA. Still these clinics will continue to use their current treatment methodologies .

Once their is FDA approval for a specific stem cells product (such as CYTORI's scleroderma treatment), things will be different for this indication: insurance coverage can kick in. Approval of many other products may then effectively close down some of these illegal clinics.

Just my opinion.

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The Scope of Unapproved US SC Treatment Centers 18 Sep 2016 05:32 #7683

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franshei wrote: FAS, re FDA pending new stem cells regs and the 500 plus stem cells clinics.

Many plastic surgeons can still do liposuction and transplant one part of the body to another part of the body, legally, as long as there are 1. no death; 2. serious side effects, 3. patient's own pay, etc. I think the plastic surgeons will continue to process their stem cells samples using ordinary centrifuges.


We will see- I am not worried- enough patients on the globe and in the US. But my knowledge is that transplanted fat will not work and it has to be enriched with stem cells.

But anyway- what I do not get- in a year or so, the rules will be straight forward and known. Will there be MEDICAL DOCTORS who knowingly are willing to break the law for a few dollars???? This would be unthinkable in Europe, except for the few exceptions that confirm the rule :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:
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