FDA

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

February 1, 2021 / By / 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 …

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

February 1, 2021 / By / 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 …

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Clinic biz US Stem Cell reports SEC subpoena, adding to uncertainty on its future

February 1, 2021 / By / 7 Comments
US-Stem-Cell-Clinic

The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the …

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

February 1, 2021 / By / 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 …

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

January 3, 2024 / By / 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 …

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

February 1, 2021 / By
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 …

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20 predictions for stem cells & regenerative medicine in 2018

December 22, 2023 / By / 4 Comments
stem-cell-crystal-ball-300x3001

Every year I look into my stem cell crystal ball and make predictions for our field including regenerative medicine. Well, I don’t really look into a crystal ball, but I try to use a combination of what I’m hearing through the grapevine, stuff I’m reading, some info that is not yet in the public domain, …

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

August 23, 2022 / By / 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 …

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Deconstructing FDA Mixed Bag Approach to Stem Cell Clinics

January 3, 2024 / By / 12 Comments
FDA-draft-guidance

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 …

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Shh! 10 stem cell clinic secrets kept from patients

February 1, 2021 / By / 19 Comments
Shh-e1507912252352

For-profit stem cell clinic secrets are bad news for patients. Stem cell clinics are in the business of making profits above all else and to make steady money they need a strong flow of patients as their paying customers for their non-FDA approved offerings. In order to keep the money pouring in, some of the …

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