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Category: Stem cells regulation

stem cell mis-regulation

Where are we Really on the on the Adipose/Fat Stem Cell and other private Stem Cell Business

Where are we Really on the on the Adipose/Fat Stem Cell and other private Stem Cell Business

There have been recent reports about the FDA’s impending forced closure of the autologous adipose stem cell business because the three-year grace period (to come into compliance with the FDA’s view of the law) is expiring soon. (The three-year grace period was extended for six months because of the pandemic.) The big dog has dutifully reported the FDA’s pronouncement about the end of the adipose and other non-FDA compliant business model and he is (as he has often done in…

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The Missouri Feds Indict a physician’s assistant/clinic operator (and recently elected State Rep) for Stem Cell fraud (and other things). Should the Private Stem Cell Crowd be worried?

The Missouri Feds Indict a physician’s assistant/clinic operator (and recently elected State Rep) for Stem Cell fraud (and other things). Should the Private Stem Cell Crowd be worried?

Earlier the week, it was widely reported that the feds indicted a woman operating a couple of regenerative medicine clinics for all kinds of fraudulent and illegal conduct. Here is an article about it. fraudindictmentarticle If you want to go deeper, here is the indictment. derges_indictment_0 It seems like she was way off the reservation for many reasons. First and foremost, she did what I think is the riskiest thing for any health care practitioner to do, namely promote an…

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California FDA Stem Cell Case Adjourned Again

California FDA Stem Cell Case Adjourned Again

Although the Pacer docket does not reflect it yet, I have heard from a client who is in communications with one of the parties that the FDA’s case against the Cell Surgical Network and Drs. Berman and Lander has been adjourned again, this time until early May. I have lost count of how many times it has been adjourned, but it’s been at least three and maybe four or even 5 times.  It is certainly starting to look like the…

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For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

For the Same Surgical Procedure Autologous Stem Cell Transplant Crowd, Big Decisions are a-coming

If you are in the business of providing autologous stem cell transplants during the same surgical procedure for therapeutic purposes, the next couple of months are going to be very consequential for you because of the decisions in the two big cases in the field. The appeal of the US Stem cell case is now under consideration by the appellate court. Oral argument was held on January 13th. By some accounts, the judges gave the government a hard time. But…

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Stem Cell End of the Year Legal Update

Stem Cell End of the Year Legal Update

As those in the field remember, in the fall of 2017,  with greatest of largesse, the FDA proclaimed that it would exercise its enforcement discretion and give all but the most egregious/dangerous private stem cell clinics three years to come into compliance with its view that autologous based stem cells, even if administered during the “same surgical procedure” were in violation of the FDA’s revised interpretation of its 21 CFR 1271 regulations. The FDA’s reimaged view of its power to…

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The FDA’s California stem cell case has a new trial date, sort of

The FDA’s California stem cell case has a new trial date, sort of

When last I reported on the FDA’s injunction action against the California stem cell treatment operation, the judge had adjourned the July trial date because of the recent alarming uptick in COVID-19 cases in the area. The court ordered the parties to confer and come up with a new proposed date in November or thereafter. The defense’s response to the order was unusual. It attempted to seek an earlier remote video trial. The judge was not prepared to do that…

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Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Stem Cell Breaking News: Cali Stem Cell Trial Adjourned until Sometime After November

Yesterday, California federal district court judge Jesus G. Bernal on his own adjourned the the FDA’s trial against Cell Surgical Network (“CSN”) and their owners Mark Berman and Elliot Lander. The parties were ordered to meet and confer about a new trial date to take place after November, 2020. The trial had been scheduled to commence on July 28th. Because of my deep interest in the case, I have been checking the Riverside Ca. Covid-19 numbers and once the numbers…

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Stem Cell Shocker: Cali. Federal Judge Denies the FDA Summary Judgement and Orders a Trial in the Cell Surgical Network Case

Stem Cell Shocker: Cali. Federal Judge Denies the FDA Summary Judgement and Orders a Trial in the Cell Surgical Network Case

Ok, let me get this out of the way up front. I predicted publicly and privately that the California federal court judge would follow the reasoning and result of the Florida federal judge who granted summary judgement to the FDA and issued a permanent injunction barring the Florida stem cell operation from using its SVF (stromal vascular fraction) product in humans. I am very happy to report that I was wrong, (at least for now and until there is a…

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FDA v. California Stem Cell case update

FDA v. California Stem Cell case update

Honestly, I lost interest in this case after the federal judge in the Florida US Stem Cell case granted summary judgement to the FDA and issued a permanent injunction barring the use of the stem cell/SVF product, which is basically the same stuff used by the California group. I assumed that the California federal judge would agree with the Florida judge. I am still making that assumption, but I did learn a few interesting things from my cursory review of…

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The US Stem Cell Judge Denies the Motions to Intervene by the SVF Owners Subject to….?

The US Stem Cell Judge Denies the Motions to Intervene by the SVF Owners Subject to….?

On July 31st, the US Stem Cell judge issued an “Omnibus Order” denying “without prejudice” all of the SVF’s Motions to Intervene in the case. Here is her order: orderdenyingintervention What is happening is confusing, even to an FDA litigator like me. But, for what it’s worth, here is my explanation of what’s going on and why we’re here, (whereever “here” is). First, I think that neither party specifically informed the judge that the company was banking SVF product for…

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