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 …
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 »
University of Minnesota bioethicist Leigh Turner has been threatened with a lawsuit by a stem cell clinic-related business. Lawsuit threats in this arena come up every so often and as much as they are unpleasant realities, they can also reveal some important aspects of the stem cell arena. Ars Technica reported yesterday that Leigh’s recent paper …
Stem cell clinic-related biz threatens researcher with lawsuit, wants retraction Read More »
Right-To-Try laws have been passed in many states across America, paving the way in theory for gravely ill patients to have the right to try unproven treatments of various kinds, and now there is a serious push underway for a national Right-To-Try law. What is a Right-To-Try law? Typically, these Right-To-Try laws allow for a patient …
Push for National Right-To-Try Law Raises Concerns in Stem Cell Community Read More »
Over the years I’ve been keeping my eyes open for advertising by stem cell clinics and lately the trend is big splashy ads in mainstream media including large daily newspapers such as the SacBee, the San Francisco Chronicle, and now the Seattle times (see below from today’s). These kinds of big ad buys on front or …
Money talks: stem cell clinic ads mushrooming in mainstream media Read More »
New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in …
Reading the tea leaves as new FDA commish Gottlieb blogs on regenerative medicine Read More »
A list of stuff for your weekend reading enjoyment ranging from research pubs to news to commentary. Electrical Stimulation Steers Neural Stem Cells. Way to go UC Davis team; see image at right. Stem cell therapies: medical experts call for strict international rules. A team calls for global efforts. Stem cells in court: historical trends in US …
I’ve seen stem cell clinic ad after ad pop up in the mainstream media in my own hometown in The Sacramento Bee paper, but others are sprouting as well and a friend sent me a particularly striking stem cell advertisement from a recent copy of the San Francisco Chronicle. Not only does this stem cell clinic …
FIX IT! SF Chronicle runs striking stem cell clinic ad with coupon Read More »