What if it seemed based on the public statements of its leader that a business was using an unapproved and unproven, genetically-modified, stem cell-based ‘cancer vaccine’ on patients? Is that possible? Sometimes I think I’ve seen and heard it all when it comes to companies marketing non-FDA approved, scientifically unproven stem cell ‘therapies’ to patients […]
Does a new lawsuit including Cell Surgical Network and its leadership as defendants pose a broad test to this entire chain of stem cell clinics, which may be the largest such affiliated clinic group in the U.S. and potentially even in the world? Will lawsuits substantially impact stem cell clinics? Lawsuits against unproven, for-profit stem cell
New lawsuit includes big stem cell clinic chain, Cell Surgical Network Read More »
What does the wide stem cell and regenerative medicine community think of California’s new stem cell law requiring that clinics selling non-FDA approved stem cell offerings make specific disclosures to prospective customers and that the state medical board keep track of how this all unfolds? You probably already know that I am supportive of the
Reactions to California’s new stem cell law on non-FDA approved clinic offerings Read More »
Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The
New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »
Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do
Dissecting the FDA’s big, fat stem cell dilemma Read More »
The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell
Stem cell clinic group, Cell Surgical Network, fires PR back at FDA Read More »
The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already
Six questions as FDA takes new shot at stem cell clinics Read More »
Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false? Do such clinics not bear any legal requirement to provide informed consent to patients? A new court ruling raises such striking questions. San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem
Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes Read More »
This morning my local paper The Sacramento Bee ran a full-page, super splashy ad for the local stem cell clinic, Nervana. Remarkably the ad says, “As Seen in The Sacramento Bee”, referring to an article by reporter Claudia Buck that ran in the past in the SacBee Insight section that raised many concerns and questions about Nervana. I may have
Splashy SacBee Ad for Stem Cell Clinic Nervana Raises More Questions Read More »
Recently I had the opportunity to talk with the leadership of Asterias, a California biotech doing exciting clinical research using stem cells as the basis for treatment of spinal cord injury. The interview covers the past (Geron patients), present, and future. I spoke with Asterias President and CEO Stephen Cartt and CMO Edward Wirth. How
Asterias interview: stem cell spinal cord injury trials advance Read More »