Search Results for: fda

When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon?

/ / 2 Comments
when-the-fat-hits-the-fire-stem-cells

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? […]

When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon? Read More »

Helpful Zettler insights from Q&A on FDA suits against stem cell clinics

/ / 1 Comment
Patti-Zettler

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it

Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »

In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms

/ / 9 Comments
Kristin-Comella1

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point

In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms Read More »

40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke

/ / 4 Comments
blowing-smoke-FDA-stem-cell-clinics

If the FDA can “go big” to issue 40 warning letters to the e-cig industry as it just yesterday, why has it recently only issued 1 or fewer warning letters per year to the unproven, for-profit stem cell clinic industry in the U.S., which includes hundreds of businesses blatantly operating in what seems to be a

40 FDA warnings to e-cig biz, but stem cell clinics allowed to keep blowing smoke Read More »

Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

/ / 16 Comments
stem-cells-eyes, stem cell therapy side effects.

Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months

Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women Read More »

Take-homes from new FDA NEJM stem cell piece including surprises

/ / 5 Comments
Peter-Marks-Scott-Gottlieb-FDA

FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some

Take-homes from new FDA NEJM stem cell piece including surprises Read More »

Animated map video shows wildfire spread of US stem cell clinics lacking FDA approval

/ / 1 Comment
stem-cell-clinic-animated-map-2010

There are now so many clinics selling non-FDA approved stem cell offerings across the U.S. that tens or hundreds of thousands of patients are at risk. How did we get here? What if we had a way of understanding how stem cell clinics spread across the U.S. in the first place? For example, an animated

Animated map video shows wildfire spread of US stem cell clinics lacking FDA approval Read More »

FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem

/
SVF2

The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning

FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem Read More »

Mesoblast gets FDA RMAT; List of 10 total designations so far

/ / 13 Comments
Mesoblast-e1514313188176

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting

Mesoblast gets FDA RMAT; List of 10 total designations so far Read More »