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 »
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 …
IntelliCell (SVFC) is a stem cell company that does cosmetic stem cell procedures. They’ve had a number of challenges of late including an FDA warning letter about a year ago and apparent financial issues manifesting in lawsuits. Now the company itself, perhaps trying to get ahead of the news, issued a press release (PR) saying they …
Intellicell Inspected By FDA: What Does It Mean? Read More »
Are MUSE cells for real? Stem cells come in different types that vary in a key property called “potency”, but very few are pluripotent. The more potency, the greater the flexibility of a stem cell to make other cell types. Flexibility in the cellular world is power. The most powerful stem cells generally used are …
Jury is still out on purported adult pluripotent stem cells despite new MUSE paper Read More »
It’s difficult to make it as a biotech company, I would say stem cell biotechs in general may have an even rougher time, and one such company, Intellicell (Intellicell Biosciences, Inc), is showing a number of signs of distress in my opinion. An online financial tool predicts the probability of companies going bankrupt within the next …
Stem cell company Intellicell facing new financial wrinkles Read More »
Dr. Steven Victor, CEO of Intellicell, seems to have made two comments on a recent blog post I did on stem cell sports medicine (see below). Victor and Intellicell received a warning letter from the FDA in March 2012 with the FDA. I’m not aware of Intellicell publicly addressing the FDA issues. If you have, Intellicell, please …
Dr. Steven Victor of Intellicell Comments on its Stem Cell Treatments 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 …
Over the last few weeks, I have enjoyed talking with and interviewing Dr. Allan Wu, of The Morrow Institute on stem cell cosmetic procedures. I was impressed greatly by his talk at the World Stem Cell Summit last year. Dr. Wu is a fellowship trained Surgical Molecular Biologist with a background in Molecular Embryology and a board …
Interview with Regenerative Surgeon, Dr. Allan Wu Read More »
The International Cellular Medicine Society (ICMS) has emerged as an important organization related to stem cell regulatory issues. I think that many people do not understand what ICMS is all about and it certainly evokes strong opinions in the stem cell field. If you care about stem cells then you need to know about ICMS …
ICMS President Rodriguez interview on adult stem cell regulatory issues 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 »