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TOPIC: New China Stem Cell Rules

New China Stem Cell Rules 27 Aug 2015 20:29 #5072

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Article on new China Stem Cell Rules. One of the most frustrating things that irks me is the appearant lack of progress from Loren Vascular. Where are the revenues from China?
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New China Stem Cell Rules 27 Aug 2015 20:56 #5073

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Thanks for the article WST

Don't you think Hedrick gave a big hint of limited expectations for the near term from Lorem ?
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New China Stem Cell Rules 27 Aug 2015 21:20 #5075

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I have always held my collective breath with Lorem and China, pipe dream IMO. But what really frustrates me is the total disassociation with what is transpiring at Okyanos. Why are we not riding the coat tails of all the success stories coming from out of the Bahamas????
I totally "OVER"estimated the positive impact it might have had for Cytori. WTF is going on with that relationship? Just pissed at this fucking total meltdown. :puke: :puke:

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New China Stem Cell Rules 27 Aug 2015 21:26 #5076

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I hear you brother. We've all lost thousands. While it's still just a paper loss, this has been a colossal meltdown as you suggest. Just plain, fat, ugly... and my bank account reflects it.
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New China Stem Cell Rules 27 Aug 2015 21:31 #5077

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Yes Hedge, I heard the same thing you did. The question is WHY? How many years has it been? I've tried to get a friendly ommunication going with the CEO of Loren and it went nowhere fast.

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New China Stem Cell Rules 27 Aug 2015 22:26 #5078

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WST...Lim sold right after the Chinese approval. Perhaps he thought there would be a pop in the PPS but I always had the nagging feeling that there was something lacking in what they got from China. Of course, I could be wrong there but just felt that way to me. Lim certainly got burnt with ATHENA stoppage.

d9...Okyanos was never a biggie for me. In fact I described what I felt would be limited "cardiac tourism" many times. To be honest, I think the fact that the Bahamas expanding the therapies they could deliver at Okyanos really saved them. DOV's spreadsheet from March I believe only had 2020 Okyanos sales at 5 million. I don't know if he still feels that's a good range or not. Maybe Fas has spoken to Matt recently and give us a update. Cytori needs tens of thousands of patients annually not a few hundred.

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New China Stem Cell Rules 27 Aug 2015 22:53 #5079

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WST,

I tried the same thing many moons ago, and Mr. Oxley just simply copied Marc and Tiago and said since Lorem was not a public company he could not comment on any of the questions I had asked in my email. Of course, I never heard anything from the Cytori clan that was copied on David's reply. It's absolutely numbing and a crock we are sitting here hypothesizing on a message board when the company should be much more forthright.

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New China Stem Cell Rules 28 Aug 2015 04:38 #5080

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What did you all expect?

I read this article also two days ago and thought it was quite vague and even included "good old Doug Sipp" chastising the rogue stem cell hospitals again. If you do, however also read the "older" articles for which links were provided in the article, it all comes together a bit.

Key is- yes you can probably sell in China to shady hospitals, but they= the Chinese Authorities DO have rules on providing clinical evidence and requiring therapy approval before you can treat patients for money.

One of these 2012 articles said:

In May 2009, the Chinese Ministry of Health classified stem-cell treatments as Category 3 medical technologies, defined as “high risk” and requiring the approval of a technical audit board before use
So far, no approvals have been granted. Despite this, “one 2009 estimate put the number of stem-cell companies based in China at around 100”, says Doug Sipp, a stem-cell ethics and regulation researcher at the RIKEN Center for Developmental Biology in Kobe, Japan. In his view, “even after the reform efforts by the Ministry of Health, the industry apparently continues to grow.


this one now said:

Regulations rising
The new measures outline requirements for such studies, including obtaining patients’ informed consent and using clinical-grade stem cells that have been approved by an independent body. They say that stem-cell clinical studies can be carried out only at authorized hospitals, and they forbid the hospitals from charging recipients or advertising. Researchers who want to do pilot studies, such as Zhou and Dai, will need to register with the health ministry with documentation showing that there are sufficient animal studies to support trials in humans and that they are using certified cell lines verified by independent evaluation.

The penalties for breaking the rules are not yet clear, although a senior health-ministry official has pledged to use them to clean up the stem-cell field in China.


The Lorem thing is a typical "pie in the sky" thing from Calhoun- who always had BIG sales in his head before having the tiniest of regulatory approval. My hope was always in the 55 investigator initiated trials- of which we hear nothing, although they surely were there and STILL ARE and which could contribute to gaining approvals.

Anyway- David Oxley´s call for clinical development partners in China, which he issued at LinkedIn is not surprising....

Heaps of work still to be done- forget Lorem for the next 3-5 years- depending on what the investigator clinics REALLY were, this will take time... :puke: :evil: :bang:

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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:

New China Stem Cell Rules 28 Aug 2015 07:10 #5081

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mr5874, I appreciate that Lorem is a private company and I prefaced my email to Oxely with that statement when I tried to get an understanding of a vague public communication he put out on LinkedIn. He is a former Cytori executive and you would think that he would appreciate the support I've given to the company over the years. When I had first contacted him, at an earlier time, he even made a reference to AF as if I were somehow associated with him. Even KT Lim was much more diplomatic when I managed to get in touch with him about a year ago, before Oxely was hired. Lim politely responded and explained that he liked to keep a low profile but was a committed believer in the technology. I had hoped to do an interview with him. I hope he still has that same commitment but I expected much more out of Lorem by now.

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New China Stem Cell Rules 28 Aug 2015 07:23 #5082

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Agree on the need for testing in China Fas but don't you think they hoped to leverage ATHENA results into their plans ?

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New China Stem Cell Rules 28 Aug 2015 08:51 #5083

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Agree on the need for testing in China Fas but don't you think they hoped to leverage ATHENA results into their plans ?


Yes, most likely. Than again- at the time "they"- that is Cytori explaining the goals of Lorem- were mainly focussed on the major aspects of the metabolic syndrome- with Type 2 clearly first, since that was prevalent in KT Lim´s family, with cardiac, renal and liver added to complete the picture.

Even if they leverage- some clinical work STILL would be required although the scope would most likely be limited and the population sizes reduced. :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:

New China Stem Cell Rules 28 Aug 2015 09:10 #5084

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***metabolic syndrome- with Type 2 clearly first, since that was prevalent in KT Lim´s family***

Hmmm...I don't remember that as first targeted goal.

***Even if they leverage- some clinical work STILL would be required although the scope would most likely be limited and the population sizes reduced***

Exactly.

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New China Stem Cell Rules 28 Aug 2015 14:20 #5087

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Everyone is totally disgusted with this company. It has been the most horrible investment of my entire career and I am frankly tired of all the lies. I would prefer a complete "mea culpa" from management and a fresh start based on whatever meager science they can prove they possess. I do not expect much but this chinese water torture is getting old. Fuck you Cytori.

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New China Stem Cell Rules 28 Aug 2015 18:55 #5089

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fatboy wrote: Everyone is totally disgusted with this company. It has been the most horrible investment of my entire career and I am frankly tired of all the lies. I would prefer a complete "mea culpa" from management and a fresh start based on whatever meager science they can prove they possess. I do not expect much but this chinese water torture is getting old. Fuck you Cytori.


YES!!!

I started reading your post expecting to tell us "haters" that there is nothing wrong and the science will win, and all is well... Then I realized that my mission is done. You guys finally woke up. Thanks to the yelling of a couple of crazy guys here screaming their balls off...


The price of greed, and the fleecing of America...

Namaste

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New China Stem Cell Rules 29 Aug 2015 15:28 #5090

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WST, I think the business strategy for the US (indications specific) is different from that for China (medical device).

For China, I think celution system is a machine plus reagents, a clinical laboratory system which can be safely and effectively delivered human cells. It is not indications specific but any human application should be backed up by prior clinical experiences.

However, marketing of such a device may not be easy, because it may not fit into the current medical setups there. This is a new market and the surface is yet to be scratched. Besides the cost burden may still be considered high, because it is an American product (if KT Lim is allowed to do the manufacturing in China, the cost basis can be very low).

I believe the patients may have to pay the cell therapy on their own. Chinese may choose other alternative treatments at lower costs (there are so many so-called ancient Chinese secrets that they can try).

I believe BTX is linked to a Chen family (physicians for several generations) in Hong Kong area, and they have a so-called stem cells clinic just outside of Hong Kong. I think it is a small operation similar to Okyanos.

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New China Stem Cell Rules 24 Dec 2015 07:14 #5816

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While I just read this thread again, I do not re-call having read Franshei´s last post.. :whistle:

WST, I think the business strategy for the US (indications specific) is different from that for China (medical device).


Franshei-

Celution´s therapies are regulated all across the globe as devices. In the US as Class III devices requiring PMA - in Japan and China having Class I approval meaning it can be worked with under specifically approved conditions leading to similar Class III claims for specific applications.

We chewed this also over 100 times and Celution will therefore never be a piece of laboratory equipment from a REGULATORY perspective although its a piece of equipment probably located in the lab... :grin: :grin: :happy: :KO:
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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:

New China Stem Cell Rules 24 Dec 2015 11:22 #5820

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FAS

The so-called New Chinese stem-cells guidelines posted on China Daily in August, 2015 are nothing new. These regs have been applied to all new therapeutics for at least the past 20 plus years. But, I think they are now applied to so-called stem cells therapeutic claims.

This is how it works, If a company brings into China a new therapeutic agent with some foreign safety and efficacy data, the Chinese government would conduct its own clinical trials in state run hospitals at no cost to the patients before formal introduction to the general public.

In the case of stem cells, I think it is still a gray area and China is really the wild west. I do not believe there is any government approvals for stem cells therapies for any specific indication to date. I believe celution system has been approved as a medical device which can be used clinically. It is a new market for Lorem to explore and grow. If Lorem is serious in this new business, Lorem needs to virtually give away celution systems to opinion leaders to explore its various uses (local experiences). Some clinics may buy the machines to harvest adipose derived stem cells and use the stem cells clinically, while the patients may have to pay for the treatment.
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