Dear FDA, The stem cell clinic clock is ticking on you. 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. Your CBER branch has been preternaturally quiet on taking actual regulatory actions on stem cell clinics for […]
Open letter to FDA: take action now on stem cell clinics before Trump Read More »
The voting on the 20 nominees for Stem Cell Person of the Year finished at midnight last night. After more than 1,000 votes, we have the top 10 finalists. These ten are some of the most remarkable people in the world of stem cells today. They have all had great impact, but in very diverse
10 finalists for Stem Cell Person of the Year 2016 Read More »
I got a package from my publisher and upon opening it I saw the Korean edition of my book GMO Sapiens on the potential use of CRISPR in humans. The English language edition can be purchased here at the publisher where you can get 35% using the discount code WS16XMAS35 until January 15th or here on Amazon.
Korean edition of my GMO book on human CRISPR is out Read More »
Some stem cell news headlines from the past week for you folks. Neuroscience: New nerves for old. Fixing stuff like strokes and paralysis. Cambridge’s Gurdon Institute and Stem Cell Institute receive five-year funding boost. Money flow to stem cells FDA “talks” stem cells in NEJM, “Clarifying Stem-Cell Therapy’s Benefits and Risks”, published on same day that 21st Century
Top stem cell & regenerative medicine headlines of the week Read More »
San Diego-based stem cell business Stemgenex is the subject of a suit over allegations about stem cell treatments. The company has now filed a motion to dismiss the case. To me as a non-attorney, the Stemgenex motion to dismiss seems to emphasize overall vagueness of the plaintiff’s case and argues in part that there is insufficient detailed support of each claim. From
Stemgenex motion to dismiss aims to rebut stem cell suit claims Read More »
There is a growing trend of apparently unhappy patients suing stem cell clinics, which have faced more lawsuits recently and some of these cases are proposed class action suits that could have much broader impact. The latest case is against San Diego-based Stemgenex, a clinic that has claimed amongst other things that it can treat numerous diverse afflictions and that
Stem cell clinic lawsuits proliferate with latest against Stemgenex Read More »
Vote on your pick for the top stem cell outside the box thinker and positive impactor in 2016 from the 20 choices below. The top 10 vote getters will be finalists from which I will have the tough task of picking the one winner as Stem Cell Person of the Year along with the $2,000
Vote now for your pick for Stem Cell Person of the Year 2016 Read More »
I received a score of great nominations for the Stem Cell Person of the Year 2016 Award and have briefly described the twenty nominees below. The point of the award is to honor the top positive stem cell leader who specifically thinks outside the box and takes risks. I’ve started an on-line vote where you can vote once per day for
20 Nominees for Stem Cell Person of the Year 2016 Award Read More »
The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field. What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the
Perspectives on Cures Act stem cell provisions possible benefits & risks Read More »
One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much
Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions Read More »