The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past […]
3rd Invitrx warning highlights FDA oversight weakness Read More »
Some unproven stem cell clinics like one called Giostar have multiple locations sprouting up. To me the concern with that spreading is the potential of multiplying risks to consumers. It can be hard to get a clear take on what these clinics are doing too. What’s in this article What is Giostar? | Giostar review |
Giostar stem cell clinic chain review, red flags, & lawsuit Read More »
The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven
Did COVID derail FDA stem cell clinic plan? Read More »
I grew up in the Seattle area so it wasn’t great to see stem cell clinics operating there recently, but better news was the WA State AG filing suit against a clinic there. The action included the clinic parent firm US Stemology along with its leader Dr. Tami Meraglia. The suit was filed only months ago
WA AG wins half million from Seattle stem cell clinic US Stemology Read More »
A planned change to the Google ads policy will allow some ads for unproven cell and gene therapies. This shift, allowing educational ads, was just announced. I have a few concerns about this change that will start in July. Google ads policy and stem cells This move seems to be a refinement of their “ad ban” policy
Google ads policy change to allow unproven cell & gene therapy educational material Read More »
There are so many stem cell clinics out there that it can be hard to keep track of them and the news about them, but a big court victory against a Manhattan stem cell clinic by New York State Attorney General Letitia James is notable for several reasons. Injunction on Park Avenue Stem Cell clinic
New York wins $5.1 million in suit against Manhattan stem cell clinic Read More »
Leigh Turner’s new Cell Stem Cell paper on the unproven stem cell clinic industry following up on our collaborative work together in 2015-2016 is great work but very discouraging. He found more than 2,700 clinics run by more than 1,000 firms in the U.S. This is several-fold growth since 2016. I’m very glad that Leigh has continued this line of
Turner pub charts runaway stem cell clinic industry; FDA needs to think big now Read More »
Because of blogging here on The Niche and people giving me tips I often can see trends before they fully surface and a troubling new one is intranasal stem cell delivery by unproven clinics. Over the past year I have heard of many clinics now offering this approach. I’ve seen this in marketing and heard
Clinics turning to potentially dangerous intranasal stem cell delivery Read More »
The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers
Translating the FDA’s Q&A on end of stem cell grace period Read More »
How can you tell who to trust in the world of stem cell therapy? What information can a patient trust? Once upon a time about a dozen years ago it seemed a much simpler question. There were universities and biotech companies doing legit research as well as clinical trials, and there were physicians doing bone
Stem cell therapy: the good, the bad, & the muddy waters Read More »