August 15, 2020

The Niche

Knoepfler lab stem cell blog

As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes?

Kimera Labs exosomes COVID-19 novel coronavirus disease
Kimera Labs photo on their webpage about idea of exosomes for COVID-19.

When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow.

Unfortunately, there are reasons to be increasingly concerned here.

For instance, the idea that stem cells or exosomes could successfully treat COVID-19 is getting more buzz by clinics and other related firms. Sometimes it is getting hyped too in the media around the world.

In fact, things have already gone so far that at least one possible COVID-19 patient may have received an unproven regenerative product without FDA clearance.

It’s hard to be sure, but other patients may have already received unproven regenerative products outside of trials both here in the US or at other locations around the world for the novel coronavirus as well.

Here are three examples of what I view as recent troubling developments in this area.

1. Exosomes & Coronavirus

Kimera labs exosome Doug Spiel COVID-19
Screenshot from LinkedIn.

Could exosomes help COVID-19? I think it’s very unlikely, but some both within and outside the clinical trial arena seem to be extremely enthusiastic about the idea.

For example, exosome supplier Kimera Labs seems interested in the potential of exosomes for the pandemic. You might remember Kimera Labs as a supplier of exosomes to a variety of customers including it seems to some stem cell clinics. The firm recently put up a webpage about this (see image above) with the header,  “Coronavirus is Here! Could Exosomes Help?”

At a biomedical level, how could exosomes given IV to patients make a positive difference in a viral illness like COVID-19? It’s not clear. Given the vast volume of blood in the human body, an infusion of exosomes would be greatly diluted. If there’s any small chance of benefit then there are some risks too.

COVID-19 patient infused with exosomes?

But there’s more.

On LinkedIn someone named Andrea Trescot, MD suggested on March 22 that Kimera Labs exosomes were already used in some clinical way in a putative COVID-19 patient, an intervention that was supposedly “orchestrated” by Dr. Douglas Spiel in New Jersey. (Note that Spiel has a clinic in NJ that appears to use Kimera’s exosome product in patients for a variety of conditions. Someone named Donna Spiel working at the clinic has been posting updates about this patient.)

See screenshot at right of the LinkedIn posting by Trescot. Note the use of the word “miraculous” and the ending of “will save countless lives.” That LinkedIn posting sounds like hype to me.

If it’s true that this patient was infused with Kimera exosomes, was this done with FDA compassionate use/expanded access approval? I’m not sure, but I kind of doubt it. What about IRB approval for experimenting on this particular patient? More broadly, to my knowledge no exosome product made by any firm in the U.S. has gotten FDA clearance for a clinical trial.

Emailing with Kimera and Spiel

I reached out to Kimera by email and the firm also connected me with Spiel. While there wasn’t much detail in our email exchange in response to my questions, I appreciate that they did reply and it generally seems likely that a possible COVID-19 patient did indeed get infused with a Kimera exosome product, apparently by a physician other than Spiel.

I pressed for details on whether there was any FDA approval, but didn’t get clarity on that so I can’t be sure.

My impression from emailing with him is that Spiel strongly believes his efforts with exosomes will help people with COVID19, but I don’t believe that’s very likely. It really boils down to this: where’s the data?

What about Kimera?

Are they at all responsible as a supplier firm for what customers do with their exosome product? That gets tricky and it in part depends in my view on whether Kimera is aware of intended clinical use of its exosome product by specific customers prior to the purchase.

Hopefully we can learn more about this situation soon. Will more patients get experimented on in this way in the mean time even if indeed there is no FDA clearance in place?

2. A self-proclaimed stem cell academy & coronavirus

The next example comes from an “academy” that I have had some doubts about ever since it appeared on the scene. The announcement reads, “The American Academy of Stem Cell Physicians Recommends a Treatment Protocol for COVID-19 to the WHO.” Their recommendations are not exactly reassuring in my view:

“1. Intravenous Vitamin C 50 grams QD (Need to check patients for G6PD deficiency before high dose IVC.)
2. Zinc 8mg IV QD
3. Vitamin D3 100000-150000 IU Intramuscularly QD
4. Chloroquine 10mg/kg bid
5. Umbilical Cord Blood – 1 million MNC/kg QD
6. Nebulizer with Amniotic fluid derived Exosomes 1 Billion/Kg Q4h.”

Any good evidence for this stuff? Is inhaling nebulized amniotic fluid into the lungs really a good idea?

3. Celltex & COVID-19

Remember our old friends at Celltex, the Texas-based stem cell clinic firm that injected then-Governor Rick Perry with non-FDA approved fat stem cells? They also received an FDA warning letter way back.

Now comes this announcement, “Celltex Plans to Launch Program to Use Mesenchymal Stem Cells for COVID-19-related Symptoms Under an Existing Regulatory Study.”

Looking ahead and what about the FDA?

Overall, it’s likely that more clinic and supplier firms are going to jump on the novel coronavirus pandemic situation. In my view, this risks doing much more harm than good.

It’s also possible that given how stretched the FDA is now during the pandemic combined with the urgent need for new COVID-19 treatments that the agency won’t do much of anything to address this issue. Instead, I hope they get engaged on this risky situation. Maybe they already are behind the scenes.

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