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Beloware the 2016 stem cell predictions I made last year and their status now color-coded near years end. Green is right, orange is mixed bag, and red is flat out wrong. <\/p>\n
Overall, I did better than most past years with only having entirely blown it on four. <\/p>\n
Stay tuned later this week for my2017 predictions, which looks to be a dramatic year in the field of stem cells and regenerative medicine. <\/p>\n
The Score Card on 2016 Predictions <\/p>\n
Screenshot from Go, go stem cells <\/p>\n
The University of Utah has a nifty stem cell learning resource called Go, Go Stem Cells! <\/p>\n
One of the things I like the most about it is that it is interactive. It is also a bit quirky and funny. Both kids and adults will enjoy learning about stem cells this way. <\/p>\n
Ive taken a screenshot above to show you the kind of interface. <\/p>\n
What do you think of Go, go stem cells? <\/p>\n
Do you know of other stem cell educational resources on-line? <\/p>\n
Some amniotic stem cell clinics seem to be trying to have their cake and eat it too. <\/p>\n
Generally the amniotic stem cell clinics market their products as stem cells and the implication is that living stem cells are used to effectively treat many medical conditions. I have not seen it mentioned that what some of the clinics, perhaps most of them, inject into patients is really a dead extract of amniotic membranes instead. Not living cells. <\/p>\n
Are the clinics injecting amniotic stem cells or just a mishmash of dead stuff fromwhat were once cells?For any given clinic selling amniotic stem cells, who knows if what they are injecting is alive or dead. <\/p>\n
Continue reading <\/p>\n
What are the hottest stem cell trends in the field today? <\/p>\n
Depends who you ask, right? <\/p>\n
One impartial way to look at stem cell trendsis through the lens of publication citations and the focuses of top stem cell papers. In that perhaps somewhat skewed, but interesting approach, the words used in the titles of the 50 most cited research publications of 2016 with the phrases stem cell(s) in their titles should tell us something interesting. <\/p>\n<\/p>\n
Fortunately publication citation platforms these days like ISI may it a snap to collect such data with a few tricks. Then I plugged the data into a word cloud generator and ta-da I got the image above. <\/p>\n
Cancer is the biggest word. Apparently cancer stem cells arehot in 2016, along with studies specifically on human stem cells with human as the second biggest word. <\/p>\n
Continue reading <\/p>\n
Dear FDA, <\/p>\n
The stem cell clinic clock is ticking on you. <\/p>\n
Before the Trump administration rolls in to possibly tie your hands on many important areas of oversight including stem cell clinics, you should take bold action now. <\/p>\n
Your CBER branch has been preternaturally quiet on taking actual regulatory actions on stem cell clinics for several years now even though there about 600 such clinics in the U.S. operating without any FDA approvals putting thousands of patients and the stem cell field at risk. Everyone knows that you are now aware of these clinics. One warning letter in a period of years is a drop in the bucket. <\/p>\n
For these same past few years you have issued draft guidances that if implemented would substantially changehow you regulate stem cells in ways that would quite helpfully put a stop to the mushrooming stem cell clinic industry. <\/p>\n
Youalso held two public meetings on stem cells in 2016, which was historic, and you received both verbal and written comments from stakeholders. The REGROW Act is history and the Cures Act is now law, with important language reinforcing your role in stem cell oversight. The clinics do not by any stretch of the imagination meet the hurdles specified in Cures. <\/p>\n
In short, much uncertainty is over. And you havedone your due diligence. The time is rightto tackle the dangerous stem cell clinic problem. You havesent clear signals that you feel strongly about proper stem cell oversight including via a late November opinion piece in the NEJMonly a few weeks ago. But words are not enough. <\/p>\n
Issue a large coordinated series of warning letters in the next couple weeks to the scores ofclinics grossly violating your regulations by experimenting on thousands of patients for profit with unapproved drugs.Now is the time. <\/p>\n
After Trumps inauguration all bets are off as to whether the new administrations FDA could still do anything about this serious problem. Strike now before his inauguration and make a profound positive difference. <\/p>\n
Best regards, <\/p>\n
Paul Knoepfler <\/p>\n
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See the original post here: <\/p>\n
The Niche - Knoepfler lab stem cell blog<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" Post navigation Beloware the 2016 stem cell predictions I made last year and their status now color-coded near years end. Continue reading