A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and […]
Court in Regenerative Sciences Case: Propagated Stem Cells Are Drugs Read More »
The voting is over and we have our top 12 finalists for the 2013 Stem Cell Person of the Year Award. You can see the final votes results below. It’s definitely an intriguing list that reflects the range of important areas in the field today. I can say without any hesitation that all 12 of
Dozen Finalists for Stem Cell Person of the Year 2013 Read More »
Nominations for Stem Cell Person of the Year 2013 closed last night and I ended up with a remarkable list of 30 nominees. I have included a few sentences about each one below, often taking verbiage directly from the nominator. The online voting on these nominees will start soon. The top vote getters will move
Below, guest blogger, John Carbona gives us his account (including pictures) of Day 2 of the Vatican Stem Cell Meeting, which included a talk by Nobel Laureate John Gurdon. Note, you can read John’s post on Day 1 of the meeting including more great pictures here. Friday, April 12, 2012 The Second International Vatican Adult
John Carbona on Day 2 of Vatican Stem Cell Meeting including Gurdon Talk Read More »
I’ve been fortunate to interview some of the greats in the stem cell field for this blog and host debates between key players. Please note that just because I have interviewed folks does not mean I agree with them or that they agree with me. The point is to establish dialogue on key issues. As
Interviews with leaders and top players in the stem cell field Read More »
There are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp. However, increasingly it is looking like the
As stem cell industry explodes, can a static FDA keep up? Read More »
Next month there is going to be a new stem cell meeting taking place. The 1st Annual Houston Stem Cell Summit. The primary sponsor is Celltex. I’d encourage everyone to go, but I’m not so sure it’d be worth it. Why? I’m always glad to see another stem cell meeting and this one is surely unique in
Houston stem cell meeting lacks diversity & risks falling to groupthink Read More »
Are stem cells drugs? At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”. The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here. The court ruled in favor of the federal government and FDA and against
Court empowers FDA to regulate stem cells as drugs Read More »
Lee Buckler is a true stem cell industry guru. As I’ve been writing this blog for the last couple years it has served as a catalyst for me to meet dozens of really interesting people including. Given all the complex events of late in the stem cell field, I asked Lee if he would do an
Great interview with Lee Buckler on stem cell industry, regulatory issues, and Celltex Read More »
Celltex has issued a press release (PR), entitled “Company Pioneering Regenerative Medicine Services Invited FDA to Inspect Lab” on their FDA audit in response to the reaction in the media and stem cell community about it. I view this PR as a step in the right direction–more openness! There is a lot of info in