This is the fourth post in a series I’m doing on an FOIA release of letters between Texas stem cell clinic Celltex and the FDA. The first three posts, which include helpful background and discussion of other FOIA material from Celltex, can be found here, here, and here. Today’s post is focused on a newly […]
Celltex FDA FOIA Letter #3 Raises Key New Questions Read More »
What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention
Time to bone up on homologous use in the stem cell field Read More »
In response to a FOIA request, the FDA informed me that they are continuing to investigate Texas stem cell clinic, Celltex. The firm has been flying somewhat under the radar lately. They have not responded to multiple requests for comments on various issues. The FDA indicated to me that what they can release in terms
FDA still investigating clinic firm Celltex Read More »
One of the more exciting stem cell biotechs out there today is Advanced Cell Technology (ACT). At this time ACT has the only two ES cell-based FDA-approved clinical trials ongoing and so far they have looked quite promising in terms of preliminary safety data. However, ACT has much more in the pipeline including potentially iPS
Interview with Gary Rabin of Advanced Cell Technology (ACT) Read More »
Harvard Stem Cell Institute (HSCI) is making a big announcement today about stems, the biggest they say in their almost decade-long existence. Last night I speculated/predicted some possible announcements. Today I’m betting they will announce the discovery of a novel factor called Betatrophin. More on Betatrophin in a minute, but first why do I think
What is Betatrophin & why is Harvard so excited about it? Read More »
Back-to-back papers (here and here) in Nature Biotechnology report the transdifferentiation (now often simply referred to as “direct reprogramming”) of plain old fibroblasts into brain cells called oligodendrocyte progenitor cells (OPCs). OPCs are a remarkably useful kind of brain cell that generates myelin, which insulates nerves. OPCs are thought to have great therapeutic potential for
I’m doing a poll on the strangest stem cell-related event of the year in 2012. The results are in and people seem to think all the candidate strange events were indeed odd, but the strangest of all was deemed the Japanese scientist Moriguchi faking that he had done iPS cell transplants on humans, a story
Strangest stem cell event of 2012: Moriguchi’s fake iPS cell transplants Read More »
What would a Romney victory mean for MS patients? Not good news I believe. As we’ve sort of, kinda gotten to know the Romney’s as potential President and First Lady, we’ve all learned some interesting things about them. I, for one, do not feel as though I know them very well still. Like many Americans,
Why a Romney victory would equal a big defeat for MS patients Read More »
In December 2011 I wrote a piece about a possible “perfect storm” of events that could crush stem cell research. Was I being too pessimistic? Now that we are into July 2012 making this fall very much closer on the horizon, how’s the forecast now? That perfect storm if anything seems more likely now. I
The perfect storm that may kill stem cell research this fall: moving closer Read More »
I have interviewed two folks on the very important US vs. Regenerative Sciences legal case: Dr. Chris Centeno and Doug Sipp. More background on the case can be found at the FDA Law Blog. I thank them both for their time and for sharing their unique perspectives. I have specific rules for these interviews and
Centeno and Sipp interview on FDA stem cell oversight Read More »