DOJ cites The Niche blog in suit vs. stem cell clinic firm: what’s scoop?

USA vs. California stem cell; The NicheIt was interesting to see that this blog The Niche was cited in the lawsuit filing by the DOJ in the U.S.A. vs. California Stem Cell Treatment Center, Cell Surgical Network (CSN), et al. case.

Yeah, that lawsuit. This suit is part of the DOJ action yesterday that along with the other suit against US Stem Cell seeks permanent injunctions against these firms related to their use of stem cells.

Here’s the passage in paragraph 60 of the suit by the DOJ citing this interview that I did here on The Niche with the leaders of CSN:

“60. In February 2017, during an interview with a professor at the University of California Davis School of Medicine, Defendants Berman and Lander confirmed that CSN affiliates were growing adipose stem cells in a lab and had not obtained any FDA approvals for their clinical approach. When asked why CSN had not obtained FDA approval, Berman and Lander indicated that CSN intended to treat patients with their products in order to collect data before contacting FDA. See”

I try to regularly reach out to other parties related to what I’m writing about including the FDA and also stem cell clinics for interviews on the blog. I often ask the clinics for their side or to do a Q&A because it seems fair and balanced to do so. I also often learn quite a bit from the interactions and posting it aids the community in understanding what is going on out there.

On two past occasions years ago I had colleagues ask me the equivalent of, “Why the heck are you doing an interview with a stem cell clinic and giving them PR?”

It’s not like I’m trying to help unproven clinics get some PR.

On the flip side, I didn’t imagine that an interview here would end up as part of a lawsuit filed by the DOJ against stem cell clinics.

One major point of this blog The Niche is to enhance knowledge hopefully in unique ways for diverse parties in our wide world of stem cells including patients.

12 thoughts on “DOJ cites The Niche blog in suit vs. stem cell clinic firm: what’s scoop?”

  1. Robert Dean, no one violently opposes adipose tissue…they are violently opposed to a medical professional flauting FDA regs with an “I know more than anyone else” attitude. For many of these doctors the Hippocratic oath was just a suggestion to be quickly ignored if there was a cash pay procedure that could top off the 401K. This is not specific to doctors or to adipose….the ethical problem is with those so attracted to the cash that they forget or choose to ignore the regulations and the science. Where there is good science, the field will grow. Where there are snake oil salesmen, the public will eventually hang them up or shut them down.

    1. I think you have it all backwards Dr. Buford. It’s those who cling dogmatically to this notion that FDA regulations are somehow the be all and end all of medical practice who concern me the most. Since the FDA represent those in positions of great federal power, many just seem to blindly follow their so called lead…or else! To me, they are the ones who have this elitist “I know more than anyone else” attitude because of that power. Power without a whole lot of truth in my opinion. (By the way, my understanding is that most medical schools today do not even administer the Hippocratic Oath upon graduation of their students….but I digress)
      Furthermore, your medical practice is just as much of a business as it is for those who work in regenerative medicine clinics. And their growing numbers demonstrate to me that the public is becoming increasingly confident in this less invasive approach to healing despite much of the negative propaganda. So, in the end, it won’t be the public who will shut the regenerative medical clinics down. It will likely be a gang of unelected nobodies working for very powerful moneyed interests only claiming to represent science and the public who will “shut them down.” And they will do this all the while likely thinking that they know more than anyone else.

    2. Ignacio Rodriguez

      Dear Don, you are right, but at any medical field we have corrupts, unethical and actitud “I know more than anyone else”, but here look only problem is with Stem Cell treatment, there are some clinic advertising miracles only interested in money, but not all.
      there very serious protocols evaluating Adult Stem Cell treatment in different condition with good result, we need more evidence, but actually only pre-clinical, and clinical evidence is using ASC, no using embryonic or iPSC.

  2. We are doing a great work for people utilizing their SVF (stromal vascular fraction) to restore and revitalize tissues and as with every great truth… it passes through three stages. First, it is ridiculed (especially through this site). Second, it is violently opposed (with lawsuits, the stage we are currently in). Third, it is accepted as being self-evident (even though the drug companies will likely prevail with their influence in calling this a drug).

    1. @Robert,
      If you are right, then prove it scientifically with placebo-controlled, adequately powered double-blind studies that you and others publish in solid, peer-reviewed journals.

      Otherwise, such claims are just anecdotal.

      I don’t see SVF as some “great truth”. It’s a biological product, not magic. It might be the basis for some real, specific therapies in the long-run that are proven safe and effective. I hope so.

      Until it is proven safe and effective, why not offer it totally for free to your patients or at a minimum just at cost with no profit margin?

      1. If you are right, then prove it scientifically with placebo-controlled, adequately powered double-blind studies that you and others publish in solid, peer-reviewed journals.

        There you go again, Dr. Knoepfler, taking a sledge hammer to a problem that requires only a feather duster. I’ve indicated as have others on this blog smaller studies that at the very least indicate the likelihood of safety and efficacy with adult stem cells. When taken as a whole I believe that most well informed patients can decide on their own whether or not they would like to try a less invasive approach to, for instance, arthritic conditions without having absolute proof of safety and efficacy at their disposal from costly and time consuming double blind multi center clinical trials. Smaller studies work well enough for our purposes as patients. Articles like this are readable, much more easily understood by the majority and don’t dive into the difficult language and numbers relative to the studies you seem to prefer.

        Clinical practice is less about proving and more about demonstrating. It, for instance, has been clinically demonstrated and accepted the use of artificial knees to replace worn out arthritic limbs. However, this practice has not been proven as absolutely safe and efficacious for all patients. Still, you seem to demand that such provable standards be met for Adult Autologous Stem Cells and SVF. Amazing!

        But since you insist on these double blind sorts of studies, I need to ask the following. What have you, your institution and laboratory done to bring these sorts of studies relative to SVF and Adult Autologous Stem Cells to fruition? You’ve indicated to me in previous posts that “we have and still do study adult stem cells as well.” Okay. To what extent? What readable published peer reviewed papers or studies have you conducted and released to the public that prove to patients that we should not pursue the sorts of therapies that Robert B. Dean has referred to above? .

        1. What can I the individual do with grandson cord blood that the storage faciliy will only release to bonafide FDA clinics. I had it stored out of state NE. 4 years ago, I am in Houston Tx. no success in any clinic that is interested in dysphagia or p l s

    2. Ignacio Rodriguez

      Robert Dean you are right
      but Paul only read what he like….
      here you are one looking for more
      Int Orthop. 2018 Aug 14. doi: 10.1007/s00264-018-4099-0.
      Hong Z1, Chen J2, Zhang S2, Zhao C2, Bi M2, Chen X1, Bi Q3,4.; Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial.

  3. Paul, you’ve done a great service, and should be proud of your contributions. I don’t think Bill is correct. I think that the value of having an interview with you will be greater now. These clinics want to justify their actions, and if they really believe that they are not subject to FDA regulation, they will want to tell you.

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