Report from Medical Board of California meeting on stem cell clinics

Dr. Charity Dean California Med Board stem cell clinics
Dr. Charity Dean of CDPH presenting at the Medical Board of California stem cell task force meeting.

This afternoon I attended and gave public comment at the Medical Board of California stem cell task force meeting on unproven stem cell clinics. There were about 40 people attending. In part this meeting is a consequence of the national governing organization of state medical boards, the Federation of State Medical Boards (FSMB) having worked on the stem cell clinic issue and crafting a policy on it. The FSMB was mentioned numerous times at the California meeting today.

I’ve written before about how our California medical board has formed this task force to address the unproven stem cell issues. It’s been slow going for this task force to get up and running, but it was great to see them in action and take part in this meeting. Drs. Howard R. Krauss and Randy W. Hawkins, task force Chairs, ran the meeting. You can see a pano picture of the start of the meeting that I took below, but not quite everyone had arrived at that point.

Medical Board of California Stem Cell Task Force Meeting
Medical Board of California Stem Cell Task Force Meeting in Sacramento.

The meeting was very interesting, especially for what some might see as just another governmental agency meeting. In fact, it has some big implications for the clinics and even the stem cell field. You can see the agenda here. There were a number of presentations at the meeting including from Maria Milan, President of CIRM. My UC Davis colleague Dr. Merhdad Abedi also spoke. Both of their talks emphasized the rigorous stem cell-related clinic trials ongoing and in development, and the risks that come from deviating from standard clinical trial and GMP practices.

Dr. Charity Dean, Assistant Director of the California Department of Public Health (CDPH) also gave a very intriguing presentation. (Yes, I’m officially a stem cell policy nerd.) Although there was quite a bit of focus on the different divisions within CDPH and how they may (or may not) have roles in overseeing stem cell clinics, the take home message seemed to be that this issue was definitely on their radar screen. Dean’s talk (and comments from her two CDPH colleagues) raised some other interesting points such as that even if a stem cell biologics manufacturer is located outside of California, if their product is shipped into California the CDPH still has some authority over it and licensing may be needed. Enforcement of an out of state supplier firm is more difficult though.

Dr. Charity Dean California Med Board stem cell clinics
Dr. Charity Dean of CDPH presenting at the Medical Board of California stem cell task force meeting.

As to actual California firms, Dean noted that it’s not always clear who in the stem cell sphere needs a license. Also, interestingly, she pointed out that from a regulatory stand point there isn’t such a thing defined as a “stem cell clinic.” It was clear that CDPH is actively monitoring the stem cell clinic situation, it tracks FDA warning letters, and it interfaces with the FDA.

Looking ahead, Drs. Krauss and Hawkins then talked about some ways the Medical Board of California might do more. They raised the idea of developing a guidance document for physicians and also producing public education materials. These could both be helpful, but I wonder whether the Board will actually take more direct action on the few physicians who are arguably running the riskiest clinics here in our state. Such a step would do the most to rein in the problem.

I was the first to give public comment after the presentations. I emphasized the large scope of the problem here in California where we have more than 100 unproven stem cell clinics. I’m not going to rehash my comments, which may be familiar to those who read The Niche, but my main point was that the practices of many unproven California stem cell clinics significantly deviate from accepted standards of care and medical professionalism, putting patients at significant risks.

While some California stem cell clinics are FDA compliant (e.g. many but not necessarily all bone marrow firms), in my view others clearly aren’t, including in many cases adipose stem cell and perinatal firms. I also raised the concern about false marketing and failure to perform proper informed consent of patients/customers by some firms, based on my interactions with patients.

There were 3 other commenters. First, was Eric Robertson, a Parkinson’s Disease patient advocate who is part of Summit for Stem Cell. He did a great job voicing his concern that the stem cell clinic problem could confuse the public and lead to negative repercussions.

The two other commenters were both physicians who use stem cells on patients, and one of them was actually associated with a clinic by name. Unfortunately, I didn’t quite catch the doctor’s names. They expressed enthusiasm for the potential of bone marrow aspirate concentrate (BMAC) for various things including orthopedic conditions, especially the first of the two of them, who also spoke about anti-aging. The second doctor also was enthusiastic about PRP. In addition, he voiced the need for better standards and transparency by those using “stem cells” about what their products actually are. He indicated his view that some of them aren’t really stem cells and some are just dead cells. I definitely agree with him on the need for more clarity on what’s actually being injected and consistency between that reality and the marketing. I actually thought that more clinic doctors would make public comment at the meeting, including some from adipose firms.

Overall, I’d say the meeting was a positive development. I just don’t know how much concrete action will come out of it and when. I also hope that other state medical boards will do more.

Note: this blog post represents my notes taken on the fly during the meeting so it may not be perfect, but to my knowledge it is accurate.

17 Comments

  1. Be careful, California is a very liberal state and I am not sure what California is regulating. The whole thing may be more about government control than stem cells!

  2. Eric Robertson is a patient advocate, who is a part of Summit for Stem Cell, which just happens to work with Jeanne Loring “toward the goal of IPS cell-based therapies for Parkinson’s” and happened to receive $2000 from @admin with input from Jeanne Loring and the leader of Summit for Stem Cell, Jenifer Raub. Nothing to see here. Move along! lol…

  3. @admin-

    Is it fair for clinics to pay their patients for testimonials? Many times you have written about that exact topic always saying its NOT ok. It’s actually illegal in most if not all states. Why is it ok for you to do it?

    Ive read in the past where you write about doctors influencing testimonials.. Are you saying that yourself, Jeanne Loring, and Jenifer Raub get to play by different rules? Did you or Eric Robertson disclose that he was actually being paid to be there and his responses came from coaching? Seems pretty shady.

    Im not heading to area 51:)

    • @Stan,
      Your comparison doesn’t make sense or hold up at all.

      A patient giving testimony about their concerns at a public California Med Board meeting is factually entirely different than a patient plugging a for-profit stem cell clinic on the web selling unproven stuff.

      In addition, Summit for Stem Cell is a non-profit patient-centric, research foundation that to my knowledge is focused IND-based clinical trial development. Patients are part of the leadership: https://www.facebook.com/summit4stemcell/.

      Years ago when Jeanne Loring won The Niche’s Stem Cell Person of the Year Award, she suggested that we give the $2K prize to Summit, which seemed like a great idea to me.

      I can’t see how Eric Robertson was paid by anybody to comment at that meeting so I think that’s also false.

        • Bill, Stan:
          I received $2000 from Paul as my reward for being elected Stem Cell Person of the Year in 2015. I didn’t want to take the money so I asked that it be donated to charity. I decided to give the money to Summit for Stem Cell Foundation, a charity that has raised funds over the years to help support my research in my academic lab before we had enough data to apply for grant funding.

          Summit is not only a non-profit, it’s completely run by volunteers, so no one is paid. There’s nothing nefarious…I doubt if Eric Robertson even knew that I’d received the money, much less who I gave it to. And I’m certain that he is sufficiently articulate on his own and did not need any coaching.

          By the way, we are not a clinic.

    • I’m considering a transurethral incision of stem cells in my prostate and would love a chat with any stem cell Dr. Lander patients.

      • @Jim,
        If you are comfortable sharing, what would the stem cells supposedly do in such a case that’s helpful?
        As a prostate cancer survivor myself, such an injection sounds risky to me.
        Paul

        • well, given what I have read, heard and spoken about with folks who have had procedures done, on thier cancer, how much more risky would stem cell injections be. impotence, pain, continue union issues et al, are no walk in the park, moreover, if it’s the difference between, just existing and watching the world go by, or taking part, even for a shorter time, I would opt for the latter. of course, this is not to say, one can’t enjoy life, after chemo, and radiation, but, it gives one pause to consider the continual options available (especially in view of the after effects) . having said that, I m a low riser, and chance taker, been one all my life, not going to stop now, unless there’s darn good reason

          • It’s difficult to know just how risky some of these things may be. The risk probably varies from very low to really high depending on many things such as who is handling the cells, how they are injected and by whom, etc. Lately infection seems like the most likely risk, while the rare possibility of tumors may be what scares some people the most.

  4. Paul,
    We should know if you QC the cells that are injected at these clinics?by flow /sequencing/digital path etc. What are you injecting? My point is after an injection what are the cell function, if any…… we scientist would like to understand how stem cell lineage can reboot rescue and repair malfunctional cells causing a disease in clinic

    • my question is, how long does that take, we hear about these studies, and the promise, some work, some don’t, but publishing results, and actually coming to market with the results are often too late for many. why doesn’t the government, put more money into R&D, instead of the newest war machines. one fighter plane, I am sure, the cost of which, if applied, would be a great leg up. just saying. it isn’t just for the aging population, but a boon to future generations as well

    • Few people have been able to get their hands on the unproven clinic stem cells, but when they have (e.g. Centeno) they have found mostly dead cells and/or non-stem cells for the perinatal products. Even some of the fat stem cell clinics admit that their “fat stem cells” (or what is called SVF) are really mostly other kinds of cells that are not stem cells. Bone marrow preps vary in the # of stem cells too.

  5. First of all, the Medical Board of California fails in their statutory duty to protect the public from harmful doctors and procedures. I know this firsthand. I would not look to this corrupt board to make important decisions regarding public health. There is no agency that is appropriately overseeing the MBC either.

    Dr. Centeno said, “…harvesting fat in a mini-liposuction is a violent affair… In order to get fat through a mini-liposuction you need to first use a scalpel to open a small incision in the skin…. In the liposuction, the whole goal is disrupting large amounts of normal tissue. In fact, the stem cells live around the blood vessels, so you have to chew up as many blood vessels in the fat as possible to get a good stem cell yield. This involves placing a small wand like device under the skin and into the fat and moving it back and forth (through much resistance) to break apart large sections of tissue… At this point in the liposuction the doctor must continue to break up large swaths of tissue with suction, sucking the broken tissue and blood vessels into a syringe…. Mini-liposuction procedures have surgical style complication rates of 3-10%.”

    “LIPOSUCTION – the surgical removal of fat – is a nontrivial procedure that may involve a painful recovery and serious complications, including but not limited to: an increase in toxic visceral fat, long-term fat mobilization, metabolic syndrome, increased insulin resistance, disturbing adipose tissue re-distribution, painful skin adherence, over-resection, muscle resection, infertility, various other structural damages, and death.” — from https://roguehealthandfitness.com/dangers-of-liposuction/

    In Clinical Anesthesiology, October 4, 2012, Michael Vlessides wrote an article entitled, “As Liposuction Deaths Mount, Study Exposes Cracks in Safety.” He said, “A quarter-century after the nation’s plastic surgeons received what amounted to carte blanche to perform liposuction, a new analysis suggests that the procedure is no safer than it was back then. Making matters worse, the researchers said, the surgery has been oversimplified in the popular media… Throw into the mix an ample supply of seemingly unscrupulous physicians and state regulators who do not appear ready to crack down on them, and the result is a recipe for national disaster.”

    I have met many of these unscrupulous physicians and state regulator who are not ready to crack down on them in California. This is clearly a disaster for public health.

    The America Society of Anesthesiologists said, “California’s liposuction regulations do not prevent patient deaths,” and “The regulations specify requirement by volume of fat removed. These are too high: patients die with even lower volumes.”

    Morbidity and mortality caused by doctors who do liposuction as part of medically recommended or cosmetic procedures is high and egregious harm is covered up by the Medical Board of California. Liposuction is financially driven and those performing do not disclose the true risks and inherently bad long-term problems involved. Many people are coerced into having liposuction through false imagery and strong advertising. Plastic surgeons and their boards put out propaganda and misleading short-term results re: liposuction.

    Doctors use online reputation management — tort reform — short statutes — the high cost of expert witnesses — threats by the perpetrators — the corruption of the Independent Medical Examiners and of judges — and jury bias makes it difficult to impossible to take a plastic surgeon to court and so they serially harm healthy people. If a victim is one of the few to make it part way through the legal process, the plaintiff lawyers may pressure victims to settle for a wholly inadequate $29,999.99 settlement that comes with a full gag clause.

    I know of many board certified plastic surgeons in California who have threatened victims who dare to speak out about how they have been harmed. A victim may be sent a bill for a corrupt and slanderous trial.

    The MBC has a problem with their plastic surgery expert witnesses who “are corrupt and lie profusely.” Being that there is no real oversight, trying to take on this issue of experimental stem cell harvesting (without dealing with the significant problems already on the table with liposuction) is dangerous and irresponsible.

    The Health Technology Advisory Committee, (HTAC), a non-partisan group formed to study liposuction said the following:

    — “Death and disfigurement due to liposuction should be a matter for serious public concern.”

    — “Since liposuction is an elective, pay-out-of-pocket procedure, data is not collected as to how many procedures are performed, the complexity of procedures, or the resultant complications.”

    — “Clear, important statistics on fatalities and complications from private offices or surgeon-owned surgery centers may be withheld.”

    — “The increasing number of liposuction procedures has led to a growing number of iatrogenic fat tissue deformities, in addition to those of traumatic and disease-related nature.”

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