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Category: Stem cells regulation

stem cell mis-regulation

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

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

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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

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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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King Canute and why the FDA will never stop the private stem cell clinics

King Canute and why the FDA will never stop the private stem cell clinics

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The FDA will never stop the private stem cell clinics and King Canute tells us why

Some perspective on private stem cell clinics and the FDA’s response

Some perspective on private stem cell clinics and the FDA’s response

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the FDA has bigger fish to fry than making a massive move against the for profit stem cell clinics

Some things in the private stem cell clinic debate are complicated, but some aren’t

Some things in the private stem cell clinic debate are complicated, but some aren’t

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I am a believer and advocate that patients should have the freedom to use their own processed and expanded stem cells. That should mean that I support US Stem Cell Clinic’s fight against the FDA’s injunction action. But I don’t. I just can’t get past the fact that this Florida stem cell operation allowed a nurse practitioner to inject stem cells into several patients’ eyeballs which resulted in total or partial blindness. A nurse practitioner! Legal though it may have…

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Update on the FDA’s Stem Cell Injunction Cases

Update on the FDA’s Stem Cell Injunction Cases

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Watching a federal civil case progress is usually about as interesting as watching grass grow, except that grass grows faster. It’s been around three months since the FDA filed permanent injunction actions against the country’s two most notorious stem cell clinics/networks, California Stem Cell Treatment Center/Cell Surgical Network and US Stem Cell Clinic and network. The most interesting thing about the cases so far is what hasn’t happened. The FDA has not filed a motion for a preliminary injunction in…

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Criminal prosecution was not a concern or consideration in Regenerative Sciences’ decision to stop treating patients in its case way back then

Criminal prosecution was not a concern or consideration in Regenerative Sciences’ decision to stop treating patients in its case way back then

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In an earlier post discussing the decision making facing the US Stem Cells and California Stem Cell Treatment Center folks, I discussed the Regenerative Sciences case in which the district court granted the government’s summary judgement motion to bar the company from providing its expanded stem cells to patients (which decision was affirmed by the Court of Appeals.) I related that the company agreed to stop treating patients with the contested procedurevery early on, pending the outcome of the injunction…

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Further thoughts on the defendants in the FDA’s stem cell injunction actions

Further thoughts on the defendants in the FDA’s stem cell injunction actions

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My post about considerations facing the defendants in the FDA’s injunction cases, http://rickjaffeesq.com/2018/05/17/hard-choices-stem-cell- defendants-fdas-injunction-cases/ was discussed yesterday in the stem cell field’s big dog, the Niche, by Paul Knoepfler. https://ipscell.com/2018/05/when-the-fat-stem-cells-hit-the-fire-will-clinics-sued-by-fda-opt-to-stop-soon/. After reading it, a follow-up is in order. A correction and follow up: In my post, I said that both US Stem Cell and California Stem Cell Treatment Center had received warning letters. Knoepfler correctly pointed out that the California company had not received a warning letter from the FDA,…

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Hard choices for the stem cell defendants in the FDA’s injunction cases

Hard choices for the stem cell defendants in the FDA’s injunction cases

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As recently reported, the FDA filed permanent injunction actions against the two highest profile stem cell clinic/operators, US Stem Cells Clinic and Cell Surgical Network/California Stem Cell Treatment. See my post at http://wp.me/p7pwQD-dz As an FDA attorney who has worked on civil and criminal stem cell investigations and cases, I can tell you that these defendants are facing a major decision: whether to stop treating patients during the pendency of the permanent injunction action. Here’s what I believe to be…

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Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

Texas Medical Board to patients needing stem cells (and the Texas legislature): Drop Dead!

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Last year, the Texas legislature passed landmark stem cell legislation (HB 810). The law didn’t open the floodgates for every physician who wanted to inject patients with stem cells. However, it did allow patients to access their own stem cells (as well as other people’s stem cells), under controlled circumstances, namely the procedure had to be performed in a high level facility (an ambulatory surgical center or hospital), and it required university type IRB (institutional Review Board) approval. Here is…

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