US Stem Cell Inc.

B+ on my report card on my 20 stem cell predictions for 2019

stem-cell-crystal-ball-predictions-1

Last year around this time I took my annual plunge to make 20 predictions for the coming year for the stem cell and regenerative medicine field. I even made a crystal ball graphic to highlight the complexity of the stem cell ecosystem into which these predictions were embedded (see image) for 2019. How’d I do? …

B+ on my report card on my 20 stem cell predictions for 2019 Read More »

Why did clinic supplier Liveyon halt sales while others have kept going despite FDA actions? Some insights including from John K

Liveyon-reincarnated

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in …

Why did clinic supplier Liveyon halt sales while others have kept going despite FDA actions? Some insights including from John K Read More »

Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game?

FDA-untitled-letter

The FDA just sent another untitled letter to a producer of a potentially non-compliant perinatal “stem cell” product that may be an unapproved drug. This follows past non-warning letters and/or inspection reports made public to Liveyon, R3 Stem Cell, Stemell, and others. RAPS has more on the story of the new letter here. This newest …

Another FDA letter to a stem cell clinic supplier: what’s the agency’s long game? Read More »

Can clinic biz US Stem reboot after losing suit? Its email to customers & more

USRM-clinic-email

The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt. If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the …

Can clinic biz US Stem reboot after losing suit? Its email to customers & more Read More »

Stem cell clinic experimenting on patients with unapproved genetically modified ‘cancer vaccine’?

USRM-stem-cell-meeting-video

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 …

Stem cell clinic experimenting on patients with unapproved genetically modified ‘cancer vaccine’? Read More »

New stem cell clinic insights from trio of critical media pieces

US-Stem-Cell-Clinic-video

Three recent media pieces on unproven, for-profit stem cell clinics paint an unflattering picture of this industry. At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going …

New stem cell clinic insights from trio of critical media pieces Read More »

Six questions as FDA takes new shot at stem cell clinics

FDA-draft-guidance

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 »

US Stem Cell bid for FDA RMAT rejected?

US-Stem-Cell-Inc.-e1498151180952

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 …

US Stem Cell bid for FDA RMAT rejected? Read More »

Stem cell fake news driving biotech investors or vice versa…or what?

US-Stem-Cell-Google-Search-e1495552962354

Is there a proliferating stem cell fake news problem in the biotech world? More broadly, the SEC is cracking down on the mess that is fake biotech news, but what about fake news on stem cell biotechs more specifically? Already in the past year I’ve seen examples of possible stem cell fake news. Hyped press releases (PR) …

Stem cell fake news driving biotech investors or vice versa…or what? Read More »