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Category: Stem cells regulation

stem cell mis-regulation

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

No Surprise: The FDA appeals Federal Judge Bernal in the Cell Surgical Network Case

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Yesterday, October 27th, the Feds filed a notice of appeal of Judge Jesus Bernal’s decision awarding Cell Surgical Network and their founders, the late Mark Berman and Eliot Lander, judgment in the FDA’s attempt to shut them down for their SVF (stromal vascular fraction) stem cell treatment. Of course, the feds were going to appeal. Contrary to the Florida district court and the Eleventh Circuit in the US Stem Cell case, Judge Bernal found that SVF was not more than…

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My Thoughts on Judge Bernal’s Decision in the Cell Surgical Network Case

My Thoughts on Judge Bernal’s Decision in the Cell Surgical Network Case

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As anyone following the private stem cell clinic saga knows, on August 30, 2022, California District Court Judge Jesus Bernal issued his decision and final judgment on the FDA attempt to enjoin Drs. Mark Berman and Eliot Lander from continuing to use their adipose stem cell treatments on patients. Their affiliate based company Cell Surgical Network (“CSN”) had many physicians throughout the country who were operating with their protocol and reporting data, which data was collected and collated by a…

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Still No Word From Cali. Judge Bernal on the Cell Surgical Network Case, But at this Point it Almost Doesn’t Matter

Still No Word From Cali. Judge Bernal on the Cell Surgical Network Case, But at this Point it Almost Doesn’t Matter

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The last entries in the court docket in the FDA’s injunction case against the Cell Surgical Network (“CSN”) and individual defendants (the late) Mark Berman and Eliot Lander were on November 5, 2021, and those mostly dealt with some belated substitution of counsel issues. Sooner or later, the decision will come out. Based on the summary judgment denial and the judge’s demeanor and comments in the trial, I thought that he might stay consistent with what he said in his…

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Sad Update on the Cell Surgical Network Stem Cell Case and its Implications: RIP Dr. Mark Berman

Sad Update on the Cell Surgical Network Stem Cell Case and its Implications: RIP Dr. Mark Berman

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Yesterday, one of the people following this blog shared a story that had just hit the papers in California: Mark Berman, MD, the co-founder of Cell Surgical Network has died. It was a little strange because the story was that Berman had died in mid-April, but that the family hadn’t previously made a public announcement. The cause of death was Covid. He apparently contracted it in January and had stopped seeing patients. Does this have any effect on the FDA’s…

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Surprise, Surprise: The FDA is Losing Big Time the War against Unregulated Stem Cell Clinics

Surprise, Surprise: The FDA is Losing Big Time the War against Unregulated Stem Cell Clinics

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Since stem cells and other HCT/P’s have come into clinical use in the early 2000s, (starting with one of my maverick doctor clients in the South), the FDA has attempted to regulate the field. Early on, the FDA adopted HCT/P regulations, that would be 21 CRF 1271. These regs made clear that allogeneic and expanded/cultured stem cells were regulated as new drugs. HOwever, there was one giant hole in the regulations, that being autologous, same surgical procedures. That hole in…

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Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

Update on the FDA’s California Stem Cell Case: So is SVF (i.e., sort of stem cells) a New Drug? That is the question

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Here is where the case stands as of September 13, 2021: Closing arguments were held on August 20th. The Judge set a short post-closing briefing schedule and both sides did briefs and replies, mostly on the definition of HCT/P’s. The reply briefs were submitted, per the judge’s order, on September 1st, as of which day the case was submitted and is now sub judice (legalese for pending decision by the court). One interesting note: Of course, the Government submitted to…

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The United States vs Your Own Stem Cells: Trial days Three and Four

The United States vs Your Own Stem Cells: Trial days Three and Four

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The FDA’s case against the California Stem Cell network went forward last Thursday and Friday for the third and fourth days. Yesterday, Monday was an off day. The trial resumes today at 8:30 PDT. Very briefly, (I hope because I have a lot on my plate today) here are my main observations: 1. The judge has already made up his mind about the case. In a sense that is an obvious implication of his decision denying the government summary judgment….

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My Crossover Moment Between Stem Cells and the Vaccine Issue, some basic facts about VAERS and maybe an interesting strategic suggestion (so please read this to the end)

My Crossover Moment Between Stem Cells and the Vaccine Issue, some basic facts about VAERS and maybe an interesting strategic suggestion (so please read this to the end)

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Although many, many of my posts lately have been about the vaccine issue, I view myself as a health care attorney who focuses on novel and unconventional treatments and technologies. The legal contexts may be different, i.e., medical board work, civil litigation, or federal criminal cases (FDA and health care insurance issues) but the overarching commonality is constant, unconventional health care and ensuring the broadest possible access to it. In my FDA-related work, that basically pits me against the government…

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Some Quick Takes on the Second Day of the California Stem Cell Treatment Trial

Some Quick Takes on the Second Day of the California Stem Cell Treatment Trial

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While working yesterday, I had the zoom California stem cell trial playing sort of as background music. Here are some of my quick takeaways. 1. My strongest impression was of the Judge. As a lawyer who does trial work, he was wonderful to watch. He is very, very sharp, but he’s also very laconic. Lawyers object. He thinks about it for a second, then gives a short response, usually 1 word. I think he was on the money every time….

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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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