A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example. He started off with a …Read More
My colleague Leigh Turner and I today published a new paper in Cell Stem Cell documenting for the first time the American stem cell clinic arena in a comprehensive way, which we found as of February has a remarkable 570 clinic locations via 351 businesses. These numbers are way beyond the predictions of most researchers and policy makers for stem cell clinics in the U.S., and point to a burgeoning, huge industry from coast to coast (see map below of clinic locations that we …Read More
Easy to understand patient guide to stem cell treatments including top 10 list of key bullet points. For better or worse, I am in the unique position of being a stem cell scientist and also a former cancer patient. Looking on the bright side this gives me a unique perspective on things compared to many of my colleagues. I know there are thousands of people out there looking for more practical information about stem cell therapies and treatments. These folks understandably are using the …Read More
The FDA stem cell meeting that was supposed to take place in April is now officially going to be a 2-day event in September. This public meeting is meant to get comments on four draft guidances related to regs on stem cell products and treatments.
Blood testing biotech Theranos finds itself in a hole that seemingly just keeps getting deeper with the report today that the company is under criminal investigation. Can it bounce back? Some people are really upset with Theranos for allegedly making misleading statements including both to investors and the government about its technologies. It’s no exaggeration to call this an uproar. However, if you think about it, what Theranos is alleged to have done is not so unusual. If one looks at medical testing and …Read More
One of the difficult things about the regulatory sphere that covers stem cells in the US is that many aspects are confusing or puzzling both to the public and so-called experts. We’ve been talking through some of the questions that come up in this area in posts and comments on this blog. What does a warning letter really mean? What triggers it? Why do some businesses selling stem cells get inspected and others don’t? What do some entities get warning letters over the years, while …Read More