Source The Niche Knoepfler Lab Stem Cell Blog
This afternoon Dr. Knoepfler 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.
He had 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.
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. 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.
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 it’s necessary to 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.
Dr. Knoepfler was the first to give public comment after the presentations, emphasizing the large scope of the problem here in California where are present more than 100 unproven stem cell clinics. His 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), others clearly aren’t, including in many cases adipose stem cell and perinatal firms, raising 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. 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.
Dr. Knoepfler definitely agrees with him on the need for more clarity on what’s actually being injected and consistency between that reality and the marketing and that more clinic doctors would make public comment at the meeting, including some from adipose firms.
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