What the heck happened to the FDA when it comes to regulating stem cell clinics? Has it given up? Or does it just seem that way because it moves in slow motion? The FDA might as well have thrown in the towel because, as I like to say, the stem cell field moves in dog years. …
Has the FDA given up on regulating stem cell clinics? Read More »
One of the most concerning new trends in the stem cell arena is the explosive growth of chains of for-profit stem cell clinics in the US including Stem MD. This kind of franchising of stem cell for-profit operations deeply concerns me in terms of its potential risks to increasing numbers of patients and to the …
Claims of Stem Cell Cures by Clinic Chain, Stem MD Read More »
The Cell Surgical Network is a large and growing group of affiliated stem cell clinics across the US. The Network providers use stromal vascular fraction (SVF) interventions for a host of conditions on a for-profit basis. Drs. Elliot Lander and Mark Berman lead the Network. They agreed to do a Q&A interview with me. Below is Part 1, …
Elliot Lander & Mark Berman Interview Part 1: A Window into Cell Surgical Network 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 »
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 …
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 »
In what could be a serious legal warning sign for the stem cell field, California federal district court Judge Jesus Bernal denied the government’s motion for summary judgement against Cell Surgical Network, et al. related to their marketing of an unproven fat stem cell product via their chain of clinics. The FDA is seeking a …