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FDA alleges Cell Surgical Network links to US Stem Cell & COVID plan

Sean Berman Cell Surgical Network, ACT

The FDA has sought injunctions in federal court against two stem cell clinic firms including the clinic chain Cell Surgical Network headquartered here in California and US Stem Cell in Florida. According to new documents filed by the government in federal court here in California there may be more ties between the clinic firms than …

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Recommended reads: Bik, FDA letter, gecko cancer model, David Baltimore on COVID origin

gecko cancer

What can a gecko possibly teach us about skin cancer? Read on. It’s fun when a week’s worth of science reading covers so much territory including COVID-19, geckos that get cancer, a research misconduct sleuth, an FDA letter, and more. Baltimore weighs in on COVID lab origin idea Caltech has a very interesting interview with …

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New data on stem cell clinics, INDs, & more including from FDA itself

arm slide fda trip program

The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a …

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FDA to end ‘grace period’ on stem cell clinics: agency should ‘go big’ on continued offenders

stem cell clinics map

Stem cell clinics violating federal regulations have been a major problem for the FDA. Next month the FDA faces a historic moment on this problem. A grace period for clinics to become FDA compliant ends in May. Even so, it appears that hundreds of clinics will remain non-compliant after that. Some of the worst clinics …

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List of FDA Approved Stem Cell Therapies & Drugs for 2024

fda stem cells sm

In the past many of us have wished there was a list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me, but I couldn’t find a list. As a result, I made a comprehensive list, which is the focus of today’s post. I’ve updated the list now in 2024 with the great …

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FDA warns Joseph Mercola on COVID-19 claims

joseph mercola and unproven stem cells

Those of you following the arena of unproven stem cells might recognize the name Dr. Joseph Mercola. He’s a promoter of alternative medicine. Over the years his name has also popped related to the marketing of unproven stem cell offerings in various ways. Now the FDA has warned Joseph Mercola on what it says are unapproved …

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Recommended reads: jobs, FDA letter, & The Niche new look

the body building fda letter the niche

During the week as I’m doing other stuff I keep my eyes open for interesting things to read, including over the weekend about stem cell research, COVID, CRISPR, and more for The Niche weekly recommended reads. This week a lot was going as we updated The Niche site to our new theme and format. I …

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FDA OK’s more COVID-19 efforts of unproven stem cell clinics

The-FDAs-big-COVID-stem-cell-clinic-can-of-worms-small

In my view, it seems likely that the FDA has opened a big can of worms by starting to clear the COVID-19 trials and programs of for-profit stem cell clinics and other related firms. OK to Stemedica trial The FDA just approved another such effort, this one by the firm Stemedica. You can read more about …

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Recommended reads: PSC, COVID, FDA pledge, sci jobs

Sarthy-et-al-eLife-2020-Fig-2

When you sit down to read science on the weekends lately, assuming you are not primarily a COVID-19 researcher, how much COVID stuff seeps into your reading? As I was going over some of this year’s recommended weekly reads posts here on The Niche, I’ve realized that an increasing amount of COVID-19 research has joined …

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