Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of […]
FDA to Put Mushrooming Fat Stem Cell Clinics on Crash Diet? Read More »
With a new document released today the FDA is more clearly on a path to regulate dubious stem cell clinics in the US. Update: in the years since this post, the FDA has more concretely defined autologous adipose stem cells as drug products. There are more than 100 such American clinics that are selling stem
FDA Draft Guidance Views Fat Stem Cells As Drugs Read More »
It’s been a seemingly rather quiet year on the FDA regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank
FDA on Key Stem Cell Regulatory Issues & Its Own Research Read More »
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 »
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
This is a guest post by Dr. Chris Centeno as I aim to bring in different viewpoints. By Christopher J. Centeno, M.D. We have noted an explosion in the number of stem cell clinics over the past several years. There’s not a day that goes by that I don’t see several new ones pop up on
Dr. Chris Centeno Guest Post on Risky Surge of Newbie Stem Cell Clinics Read More »