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TOPIC: Hey Hey FDA: Autologous Realtime is the WAY

Hey Hey FDA: Autologous Realtime is the WAY 24 Apr 2014 07:12 #1592

  • rongside
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www.fda.gov/ForConsumers/ConsumerUpdates/ucm393030.htm

The scientists’ investigational work is unprecedented: Seven labs at FDA's Center for Biologics Evaluation and Research formed the consortium to fill in gaps in knowledge about how stem cells function.

“This research aims to facilitate development of this important class of innovative medical products,” explains Carolyn A. Wilson, Ph.D., associate director for research at the center. “It’s the first time we’ve done anything like this, and it’s proven to be a very useful approach. It’s worked so well because this is a huge, complicated project that requires expertise in many different technologies and methods.”

Looks like the FDA is getting serious about stem cells. They appreciate the potential of MSC but are wary of a variety of things that can go wrong. What they are concerned about is the allogeneic use and the cell manufacture/expansion process. Neither is a factor for the Celution device. :woohoo:

IT IS IMPERATIVE THAT CELUTION BE ADOPTED ASAP IN AS MANY INDICATIONS AS POSSIBLE, THEN THE ONUS WILL BE ON THE OTHERS TO PROVIDE BETTER TREATMENT OPTIONS IN A COST EFFECTIVE MANNER. NOT SO EASY.

WE HAVE STRATEGIC ADVANTAGES OVER OUR COMPETITORS. PLEASE CYTX DON'T BLOW IT. THE FDA SEES THIS AS BEING THE FUTURE OF MEDICINE................ OBVIOUSLY, SO MUST BIG PHARMA. :grin:

Sorry about being loud (capitals)............. but if CYTX is not going to blow their horn I will !!! :happy: :
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Hey Hey FDA: Autologous Realtime is the WAY 24 Apr 2014 09:50 #1593

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Thanks rongside for the post. we know we know, but unfortunately nobody wants to believe CYTORI. Down again today. Very frustrating for all. Don't think anyone can explain why nobody believe but they don't and shorts are betting this will go lower. BARDA looms larger every day.
Wall Street posts he believes each day we hear nothing is an indication things are going well with BARDA. I don't understand his logic, as one would think they would be excited to move forward and review meeting to determine if that is going to happen would be scheduled. Perhaps it has been . Hendrik says they speak to FDA multiple times a week . The FDA meet was pre requite to BARDA sit down. I can't take much more of this. Could it be the markets are so manipulated that they are trying to shake as many investors out by killing pps and stealing there shares as some surmise. I find that hard to swallow.So we hurry up and wait.

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Hey Hey FDA: Autologous Realtime is the WAY 24 Apr 2014 10:31 #1594

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John-

You probably know David Granowski and his apostolic work also - this is how he reacted (mind you- the NIH has sponsored a lot of work already in the past)

Better late than never...14 years after serious adult stem cell research began in other parts of the world, the FDA finally woke up and they are beginning, BEGINNING to research adult stem cells. They even made a positive statement about their regenerative promise. We'll call this one a victory in that the outcry for adult stem cells has been so loud, the FDA finally relented and have begun research. Better late than never. Thanks for coming to the party FDA...

But...14 years late to the party. Reminds me of the last scene in Schindler's list. How many lives could have been saved? How much suffering could have been eased. Well, let's do the math.

"...in 2005 there were 2,448,000 deaths in the u.s.
4 of the top 6 killers were:

Heart disease (652,000 deaths)
Cancer (559,000 deaths)
Stroke (143,000 deaths)
Diabetes (75,000 deaths)

There were a total of 1,429,000 deaths in 2005 from these 4 diseases and there are renowned stem cell treatment centers around the world that have been successfully treating patients with these disease for years. Around the world, people with these disease are actively receiving asc treatments and benefiting from them.

How many of those 1,429,000 deaths in the USA Could have been averted with asc treatment? How many of those 1,429,000 lives in the u.s. Could have been extended with asc treatment until other treatments were available? We’ll never know. Maybe we could have saved 30% of those people with asc or 428,700 people per year. Over 10 years that might amount to 4,287,000 people saved.

Saving 10% = 142,900 per year or 1,429,000 people saved in 10 years.
Even saving just 2% = 28,580 people per year amounts to 285,800 over 10 years." [With a potential of 15,000,000 saved over 10 years.]
via repairstemcell.wordpress.com/stem-cells-101/

So when the FDA starts tooting their horn about showing up to the party, doing great research, working on unprecedented projects, the promise of adult stem cells and the ultimate success they will achieve...remind them they are doing so on the tail coats of the innumerable scientists, doctors and patients who have blazed the path before them...and please remind them to apologize to the millions who have died waiting for stem cell treatments in the USA. repairstemcell.wordpress.com/why-no-stem-cells-in-the-us/
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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:

Hey Hey FDA: Autologous Realtime is the WAY 24 Apr 2014 14:36 #1595

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Fas,

You are absolutely right. It is a sin how American medicine has had to treat these therapies as a stepchild. A remnant of the debacle the right wing made when embryonic stem cells were pegged to abortion clinics. This is a great but a crazy country. I think they would still burn a witch here if they could find one. Maybe even elect her president.

Notice the FDA still won't mention embryonic stem cells. So the further we can get from that point the better. That is why I was so intrigued by autologous cells. I still am. I hope things start to move in the right direction.

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