Stem cell clinic experimenting on patients with unapproved genetically modified ‘cancer vaccine’?

What if it seemed based on the public statements of its leader that a business was using an unapproved and unproven, genetically-modified, stem cell-based ‘cancer vaccine’ on patients?

Is that possible?

Sometimes I think I’ve seen and heard it all when it comes to companies marketing non-FDA approved, scientifically unproven stem cell ‘therapies’ to patients after 8+ years blogging here, but then I run across something new each year that still surprises me.

For example, in a mind-blowing video that the company posted on Facebook the leader of U.S. Stem Cell, Inc. ($USRM, a publicly traded stem cell clinic firm), Kristen Comella, seems to be indicating to an audience that her firm might already be administering some kind of stem cell-based “cancer vaccine” to patients. This possibly genetically-modified product would almost certainly not have been approved by the FDA nor tested first in rigorous preclinical studies in animals.

The video as a whole provides many other striking insights into USRM and the stem cell clinic industry (which I’ll cover in a separate follow-up post), but if you go to about the 43.5-minute mark in this video, you can see the cancer-related thing that struck me as so concerning. Comella begins talking about how her company has a cancer “protocol.” She also mentions electroporation and a “cancer vaccine” mechanism suggested to involve antigen presentation.

What’s the deal here? It’s difficult to be sure.

I got no reply to an email that I sent to Comella a month or so back via which I was trying to get some more clarity on what USRM was doing with cancer through asking some straightforward questions. Even without further specifics, in my opinion as a stem cell and cancer researcher as well as a cancer survivor myself, there is plenty in the video to be deeply concerned about regarding the possible cancer “vaccine” protocol mentioned.

Here are some key points that stood out and questions that came to mind as I’ve been pondering this.

• Genetically modifying stem cells for clinical use? Electroporation is typically something we do in a lab to insert DNA (or much less often RNA) into cells for in vitro studies. It is an electric jolt to cells in a special glass tube called a cuvette generally used to get DNA into them so it is a form of genetic modification. It can be tricky to get right so as to get the DNA in without killing all of the cells. For instance, I accidentally killed my cells a few times as a postdoc when there was an arc of electricity. I don’t have a clear picture of the exact details of what USRM is doing on this front, but if they are in fact genetically modifying stem cells via DNA electroporation and then giving the cells to cancer patients without pre-clinical science to back it up and without FDA approval, this could be extremely dangerous. I hope the company will clarify this situation.
• What is going into the cells and how risky is this? Then there’s the question of what specific DNA (RNA?) that USRM might be electroporating into the stem cells prior to use. She mentions a protein from the patients’ own cancer in the video. If USRM is electroporating in the DNA to express cancer-related proteins in patients’ stem cells and then infusing the genetically modified MSCs back into the patients, that potentially could cause new cancers and could also spark dangerous immune reactions as a side effect. It seems to me more generally like this might be an effort potentially trying to build on the excitement in the field over CAR-T cells, but these wouldn’t be CAR-T cells.
• Where would the electroporated material come from? I also wonder about the source of whatever they are electroporating into the stem cells to make their “vaccine” as such materials intended for clinical use in patients would have to be made in a very particular, rigorous kind of laboratory facility with strict environmental controls and equipment dedicated to only being used for processing drug products. For instance, you can’t just make a regular old prep of DNA (or RNA or whatever is being electroporated) like we do in the lab for in vitro studies if you are going to use it for a clinical protocol. It would further increase risk.
• Would the cells be cultured in a lab? Typically to electroporate cells, one would first grow them, then zap them, and then put them in culture again for some period of time to recover prior to the end use. If indeed that is happening, the step(s) with the cells in a dish in the lab not only raises risks, but also add to other multiple factors here making this a case of a product seeming to me at least to be almost certainly a drug requiring pre-approval.
• Efficacy? I also am skeptical about efficacy of this kind of approach, especially as done without peer-reviewed pre-clinical data to back it up. In addition, some cancer patients who might get this hypothetical ‘cancer vaccine’-like intervention, may end up choosing to stop other therapeutic approaches that are more likely to have beneficial results.
• Maybe this is just an idea and not actually an active protocol? Perhaps I got the wrong impression from this video? Maybe USRM isn’t already infusing modified stem cells into cancer patients, but it’s just an idea of theirs? I guess that’s possible, but instead it sure sounds like this has already been done on patients. Again, I hope USRM can clarify.

Stem cell clinics get more interested in cancer overall. There is other stem cell clinic activity on the cancer front. A California-based stem cell clinic firm, California Stem Cell Treatment Center (part of Cell Surgical Network) along with a second firm were subject to FDA action last year related to an unapproved cancer-related product reportedly seized by US Marshalls. It apparently involved mixing stem cells with smallpox vaccine, which to me at least seems like another very high-risk, unapproved ‘cancer vaccine’ kind of idea. More broadly, over the years I’ve also seen some other stem cell clinics claim that various kinds of unproven stem cells can work for cancer.

Overall, I’m extremely skeptical that unproven stem cell clinics can help cancer patients by wading into the cancer arena generally without strong preclinical data, lacking FDA-approval, often with no medical oncology experience, etc.

In my opinion it is far more likely that already hurting cancer patients would get hurt more.

For patients. For these reasons, if you are a cancer patient or a loved one of a patient reading this, I would strongly caution against getting an unapproved cancer therapy outside of a proper clinical trial. Even traditional clinical trials have risks, but they are typically based on extensive preclinical animal model data and are conducted in a very careful manner following FDA guidelines.

If you or a loved one are in a particularly desperate situation with a potentially lethal cancer such as one that has metastasized or recurred and there’s no available approved treatment nor active clinical trial available for you/your family member, instead of going to a stem cell clinic, consider applying to the FDA for a compassionate use exemption with the particular company/sponsor developing the new experimental cancer product of interest, if the company is willing. The FDA approves almost 100% of these, does so quickly these days, the company presumably would have oncology expertise, and at least there would be some vetting of data even via this still relatively risky route.

As a person who has faced a potentially lethal cancer, I get what you might be feeling and I understand that risk has to balanced with the nature of a particular health situation. Also to be clear, I’m not a medical doctor and am not giving medical advice, but these suggestions to use caution are just based on my experience as a stem cell and cancer researcher and cancer patient as well as common sense. Talk to your oncologist(s) and primary cancer physician for expert medical advice.

Marketing unproven CRISPR to patients? Much more broadly, there is some concern that well beyond the scope of stem cell clinics, other firms may start selling unapproved and unproven genetic modification services such as via CRISPR directly to patients. I hope in future years we won’t be seeing a major problem of unproven, for-profit “CRISPR clinics” in the way we have now with stem cell clinics.

Again, I’m going to do a second post on this USRM video, which had some other notable statements.