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 »
What the heck is going on with Intellicell Biosystems, Inc. (SVFC, also SVFCE), a stem cell corporation run by Dr. Steven Victor? Why are some on Wall Street seeming so bullish on the company lately? What’s the real story and the facts? What is the key background on this company? Wall Street has been buying …
Wall Street Weirdness Over Stem Cell Biotech Intellicell (SVFC) Read More »
A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed letters from Celltex to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I …
Every now and then I like to do something different in the way of posting something not focused on stem cells, and today it’s all about growing a giant pumpkin. If you’re in a Halloween kind of mood early, you might enjoy this post I did on what really scares scientists on Halloween. Gardening, science, …
Over at Health in the Global Village, Leigh Turner yesterday published an excellent piece updating us all on the latest news on Korean stem cell company RNL BIo (알앤엘바이오) and its leader, Dr. Jeong Chan Ra (라정찬 ). Addition: The story was reported in several Korean news outlets including Hani here. A video here by MBC News of Korea, one …
Jeong Chan Ra Arrest: Can RNL Bio (알앤엘바이오) Survive? Read More »
In a rare sign of stem cell international regulatory unity, the Japanese Health Ministry (厚生労働省) and the US FDA have agreed to develop a joint, unified regulatory framework for clinical studies of human iPS cells for use in treating retinal diseases. Presumably the rules would also guide clinical use of iPS cells to treat other …
FDA & Japanese Health Ministry (厚生労働省) To Develop iPS cell clinical rules Read More »
I’ve been researching the issue of how intellectual property (IP) and patents to induced pluripotent stem (iPS) cell will influence the field. It’s a complicated, worrisome picture in terms of getting this technology to patients to help them. I’m concerned there may be an all out patent war. Even for those who do not go …
Sky’s the limit on iPS cell licensure cost from Academia Japan Read More »
I’m doing a series of posts on my recent conversation with BioTime CEO and pioneer of the stem cell field, Dr. Mike West. You can read Part 1 and Part 2 on Geron, ACT, and the history of the pluripotent stem cell field, particularly embryonic stem cells (ESCs). Today in Part 3, I am focusing on …
Mike West Interview Part 3: key flaw in stem cell field Read More »
Texas Governor Rick Perry just announced that he will not run again for governor. This political development has important impact in the stem cell field, particularly in the state of Texas. Perry is one of the biggest advocates of certain types of adult stem cell commercialization. When he is no longer governor there will be impact …
Celltex advocate Rick Perry will not run again for Texas governor: stem cell impact Read More »
Celltex is still in the mix with the FDA and who knows how that will turn out. Several documents were revealed via FOIA that provide insight into the goings on at Celltex since 2012. Two documents are letters from Celltex to the FDA dated April 27, 2012 and May 18, 2012, while a third is a …
Celltex letters to the FDA revealed by FOIA: first is reaction to Leigh Turner Read More »