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 »
Professor Joanne Kurtzberg’s clinical work at the Duke Autism Center on umbilical cord blood for autism and cerebral palsy (CP) involves a partnership with a publicly-traded cord blood banking firm called Cryo-Cell. Kurtzberg is also the Medical Director at the firm. In addition they have intellectual property in this area. The Duke team’s efforts, including
Duke & Cryo-Cell plan big clinic for unproven infusions of kids Read More »
The idea of testing stem cells for COVID-19 may be music to the ears of some folks as an opportunity, but to me from the beginning it sounded mostly like a spaghetti on the wall road to trouble. There is buzz out there that some kind of stem cells or other cells will help with
Field throws stem cells for COVID-19 like spaghetti on the wall Read More »
US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to
Kristin Comella resigns from embattled clinic firm US Stem Cell Read More »
There once was a place called The Morrow Institute here in California run by a physician named David Morrow. This clinic did various kinds of cosmetic procedures and also unproven, non-FDA approved fat stem cell-related stuff too for some years. Last month during some research on clinics I found several media links (e.g. here) from
Institutional review boards or IRBs are some of the biggest enablers of risky, unproven stem cell clinics. We often see statements on stem cell clinic websites to the effect that they have approvals from IRBs so the clinic firms must think that patients like to see that. Why would specific IRBs approve for-profit “experiments” by
FDA needs to quickly act against IRBs enabling risky fat stem cell clinics Read More »
The US has been bursting at the seams with unproven stem cell clinics for years, which in my view necessitates some kind of bold action by the FDA and other governmental agencies so I’ve wondered what new FDA Commissioner Dr. Scott Gottlieb would do on this front. The lead up to and beginning of a
FDA under Scott Gottlieb goes large on stem cell clinics with crackdown likely Read More »
We need more investigations of for-profit stem cell clinics selling what some view as ‘snake oil.’ Over the years I’ve mainly resisted using terms like “snake oil,” but that phrase is being used more often and more recently I think we need to be blunt about what is being sold. Part of effectively countering the
Several new investigations expose ‘snake oil’ stem cell clinics Read More »
Is “snake oil” too harsh a term for some of what is sold at some of the worst stem cell clinics? Is the phrase “stem cell clinics” itself accurate and useful in a broad sense? When we read or write the phrase “stem cell clinics”, most people generally know what we’re talking about, but it
What should we call “stem cell clinics” & is “snake oil” too harsh for some? Read More »
According to The Bismarck Tribune and the AP/US News & World Report, the North Dakota Attorney General’s office is investigating a stem cell clinic in that state amid complaints. From the news articles: “The clinic has been offering stem cell injections for about a week and a half. Consumer Protection Division Director Parrell Grossman says there are
‘Very Alarmed’: North Dakota AG Investigating Stem Cell Clinic Read More »