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Category: Stem cells regulation

stem cell mis-regulation

Breaking News in the US Stem Cell Injunction Case!

Breaking News in the US Stem Cell Injunction Case!

But first a ho hum update Last week, both parties filed motions for summary judgment. What that means is that both sides are arguing that there is no need for a trial and that the judge can decide the case on the summary judgment papers. The government argues of course that the defendants are violating FDA law by using their more than minimally manipulated products for non homologous use, and that it doesn’t fit within the same day surgical procedure…

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There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

Recent fillings and orders which were expected: Longer papers for summary judgement. The parties jointly moved to allow each to file more pages than is allowed for summary judgment under the local rules. The parties wanted double the amount. The judge gave them less. Yesterday the parties filed a joint motion to cancel the local rule required mediation. Mediation is a waste of time in a case like this. There’s no money damages sought, and the Government already told US…

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A Injured Stem Cell Patient’s Story

A Injured Stem Cell Patient’s Story

I previously posted about a west coast stem clinic which had injured several dozen patients with its autologous based stem cell product. Here is a link to the prior post: http://rickjaffeesq.com/2019/01/13/what-should-happen-if-a-stem-cell-clinic-harms-many-patients-revised/ Here is the story on one of the patients, written in her own words, with some deletions and redactions to de-identify the clinic. The clinic told me I was an excellent candidate for their Lyme SVF stem cell treatment. They promised this treatment would boost my immune system to…

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Is cord blood/umbilical cord stem cell treatment legal?

Is cord blood/umbilical cord stem cell treatment legal?

Virtually all the attention I’ve given to stem cells in my prior posts has been on autologous stem cell transplants. But the private stem cell clinic industry actually started with cord blood back in the early part of this century. I have written about the start of this field and the FDA’s first two cord blood clinic criminal investigations in Galileo’s Lawyer. The short of it is that even back then, the FDA didn’t think a private clinic’s use of…

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THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE

THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE

A little over a year ago, the FDA made public its final guidance documents in the stem cell field (HCT/P’s in FDA parlance). The documents were highly restrictive and all but eliminated the use of autologous stem cells outside of clinical trials. (I have written about this many, many times. Just scroll through some of my prior posts in the stem cell category on my home page). Apart from being wrong, my view has been that the FDA does not…

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What Should Happen if a Stem Cell Clinic Harms Many Patients?

What Should Happen if a Stem Cell Clinic Harms Many Patients?

Here’s my core position: I support a patient’s access to his/her own stem cells for any use agreed to by the patient after proper informed consent which is not tainted by false or misleading advertising claims by the stem cell clinic. My philosophical/public policy/constitutional thinking is that people do/should have a right to determine what happens to their own bodies, so long as that right doesn’t endanger public health or safety, or impinge on another’s protected rights. I don’t see…

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Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Now would be a good time for private stem cell clinics to change their web site advertising

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

A few days ago, the big dog blogged that a San Diego TV station was reporting that the Medical Board of California (MBC) has announced its intention to form a task force to “investigate” private stem cell clinics, presumably following the Federation of State Medical Board’s (Federation) report on the subject. Here is the post: https://ipscell.com/2018/11/medical-board-of-california-task-force-to-investigate-stem-cell-clinics/ The intended or unintended implication is that all these clinics are about to be shut down by the MBC. But let’s take a breath….

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Private stem cell clinics should start worrying about some new regulatory players

Private stem cell clinics should start worrying about some new regulatory players

Up until very recently, the FDA has basically been the sole regulatory threat to the private/for-profit stem cell clinics, via published guidance documents, site inspections, warning letters and the recent federal civil injunction cases against the two biggest stem cell operations. See my posts about the status of these cases at: http://rickjaffeesq.com/2018/09/26/update-on-fda-injunction-cases/ As an aside It’s no coincidence that the defendants in both of these injunction cases have many dozens of so-called “affiliate” stem cell clinics throughout the country. Both…

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The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

The grass is still growing ever so slowly in the FDA’s injunction cases against U.S. and California Stem Cell Clinics

Since my last update about these cases in early August, not much has happened, which is to be expected in federal civil litigation. Nonetheless, here is an update. Let’s start with what hasn’t happened 1. There has been no announced agreement in either case that the defendants have stopped treating patients with their SVF, stem cell therapy which the FDA claims are unapproved new drugs, adulterated and misbranded, pending the final decision by the judges in these injunction actions. 2…

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