Browsed by
Category: Stem cells regulation

stem cell mis-regulation

The FDA’s injunction complaints against US Stem Cell Clinic and California Stem Cell Treatment Center

The FDA’s injunction complaints against US Stem Cell Clinic and California Stem Cell Treatment Center

Comments 0 Comment

Yesterday, May, 9th the FDA filed complaints seeking permanent injunctions in Florida and California federal courts against the two highest visibility U.S. stem cell operations. For the interested, here are the complaints. comella bermancomplaint What’s in the complaints? It’s pretty much as I said in yesterday’s post. The two complaints are substantially identical and no doubt prepared in Washington, primarily by the FDA with input from Main Justice (or vice versa). Both entities were inspected by the FDA, after which…

Read More Read More

Hot off the press: The other shoe drops on stem cell clinics

Hot off the press: The other shoe drops on stem cell clinics

Comments 0 Comment

The Washington Times reported today that the FDA has filed permanent injunction lawsuits against the two most high profile U.S. stem cell clinics. Here is the article: https://www.washingtontimes.com/news/2018/may/9/doj-moves-shut-down-two-stem-cell-clinics/ Both of these clinics received FDA warning letters last year indicating that their operation violated federal law. Today’s action by the FDA in the logical and inevitable conclusion of the FDA’s multi-year effort to eradicate stem cell clinics using autologous stem cell treatments. See my end of year post, laying out what…

Read More Read More

First 2018 Stem Cell Update

First 2018 Stem Cell Update

Comments 0 Comment

We’re now beginning the second month of 2018, and we are a few months past the FDA’s issuance of the final stem cell guidance documents which are intended to dramatically limit the availability of stem cell treatments outside of FDA approved clinical trials. See my prior post at: http://wp.me/p7pwQD-bB So what’s going on so far in 2018? FDA Inspections? Rumor has it that there already have been several facility inspections this year. What I can say is that it’s more…

Read More Read More

FDA sends a Happy New Year greeting to another stem cell operation!

FDA sends a Happy New Year greeting to another stem cell operation!

Comments 0 Comment

As a prelude to more of what may be coming this year, the FDA has issued its first warning letter to a for-profit stem cell entity, on the third working day of the New Year. As per previous posts, expect more to follow in the coming weeks and months, targeting the most visible stem cell only entities. Here is the warning letter: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm Same ol, same ol, but with a twist The letter is largely the FDA’s standard form warning…

Read More Read More

The year in review and some predictions about next year/ Part One: Stem Cells

The year in review and some predictions about next year/ Part One: Stem Cells

Comments 0 Comment

It’s time to look back at what happened this year, and make some predictions about next year. Part One will focus on stem cells. We started 2017 awaiting the FDA’s final guidance documents on HCT/P’s (“stem cells”). In late August, the FDA foreshadowed the guidance documents by issuing warning letters to two of most high profile (or infamous) stem cell clinics in the country. Both clinics were warned that their use of HCT/P’s were in violation of the FDA trifecta…

Read More Read More

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

Comments 7 comments

I’ve just had the distinct but perhaps questionable honor of being quoted extensively by the Grand Inquisitor of all things unconventional (medicine wise). here is his post: https://respectfulinsolence.com/2017/11/21/fda-cracks-quack-stem-cell-clinics/ Like M.C. Escher so brilliantly explains in his pictures, it all depends on your perspective, whether you think the the FDA final guidance documents are a good or bad thing. But, one thing I’ve never been able to figure out about the other side is why the obsession with the stem cell…

Read More Read More

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Comments 2 comments

As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s. The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well,…

Read More Read More

California enacts a new stem cell law, but it won’t do or change anything

California enacts a new stem cell law, but it won’t do or change anything

Comments 0 Comment

On Monday, October 2, 2017, Gov. Jerry Brown signed into law SB 512, which requires what I call the practice of medicine stem cell clinics to notify their patients that the use of stem cells by the clinic is not FDA approved. And that’s it! Here is the link to the law: http://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=201720180SB512 The law should be a welcome relief to the hundred plus California clinics that provide stem cell treatments to patients, because it does not affect their businesses…

Read More Read More

The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

The Sleeping Giant Awakens: The FDA starts its final push to eliminate practice of medicine stem cell clinics

Comments 6 comments

In late August, the FDA issued a trilogy of pubic actions and announcements advancing its goal of shutting down what I’ll call the practice of medicine stem cell clinics (“POM”). These clinics provide autologous stem cells and other autologous tissue or tissue based products which have not been approved by the FDA. These clinics have exploded in popularity over the past dozen years, which has caused the FDA and the stem cell institutional players much angst. The FDA’s efforts to…

Read More Read More

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Landmark Texas Stem Cell Legislation Gets through the Texas Legislature!

Comments 2 comments

Over the Memorial Day weekend, the Texas Legislature passed amended HB 810, which allows access to autologous (yours) and allogenic (not your) stem cells. It is landmark legislation in that it is the first state law allowing access to stem cell treatments which are not FDA approved, and which do not fit within the narrow types of autologous stem cell treatments permissible under federal law. Here is the amended bill awaiting the Governor’s signature. (The Governor has previously tweeted that…

Read More Read More