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 »
In a nutshell, what does all of this week’s big FDA developments on stem cells and regenerative medicine mean for stem cell clinics? There’s much to be upbeat about so overall I’d say it’s good news, but I see three significant potential problems too. Dang. The good news is that the FDA seems determined to …
Deconstructing FDA Mixed Bag Approach to Stem Cell Clinics Read More »
Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …
Fat stem cells are drugs: new FDA final guidances Read More »
The ability of for-profit stem cell clinics to pitch unproven, risky stem cell offerings to patients may soon get much tougher in Australia. The country’s Therapeutic Goods Administration (TGA), which has some similar responsibilities there as the FDA does here in the U.S., announced planned new reforms that’ll put stem cell clinics under more scrutiny and more …
Australia takes big step to curtail dangerous stem cell clinics 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 …
Who are the top stem cell influencers? Terrapin asked this kind of question to some within our community 4 years ago and came up with a Top 50 list of stem cell influencers, which I like to joke I was “at the top of” because I was #50 and they listed us in reverse chronological order. …
List of Top 50 stem cell influencers on Twitter to follow 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 »
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 »
Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The …