WHYY oh WHYY: NPR puff piece on risky stem cell microneedling

I usually associate NPR with solid journalism so I was scratching my head about a recent puff piece by WHYY on stem cell microneedling. 

Is this journalism or product promotion?

The NPR piece by Maiken Scott doesn’t ask important questions. Scott received stem cell microneedling herself using a product from a company called AnteAGE. How does that work? What’s the deal with microneedling more generally?

Let’s dig into this odd arena.

What is stem cell microneedling? | How WHYY piece failed | Stem cell microneedling risks | Someone else’s bio material | Is it FDA compliant? | Cellese & AnteAGE | Reaching out to the firm | References

What is stem cell microneedling?

I’ll start by explaining the procedure. Then I’ll get into WHYY’s poor coverage and why the procedure could be very risky.

Stem cell microneedling is similar to the old vampire facelifts or facials. The vampire stuff blew onto the cosmetics scene starting about a decade ago. They’re still popular today but raise serious public health concerns. More on that in a minute.

In vampire facelifts or facials, customers have their faces punctured with a pin-covered roller. This makes hundreds or thousands of punctures on the face. Blood supposedly containing stem cells is applied and then percolates into the holes. This is claimed to rejuvenate the face in part by stimulating new collagen production. In the vampire facelift, clinics use your own blood.

In “stem cell microneedling”, things start similarly with the vast micropuncturing of the face. But instead of blood, what’s called “conditioned media” comes into play. It’s secretions from someone else’s bone marrow cells in this case. Once in the face holes, the media is supposed to do something helpful.

Is this really a stem cell-related procedure? It is possible the bone marrow cells that make the conditioned media are actual stem cells but that’d be surprising to me. True hematopoietic stem cells are not that common among marrow cells and would have to be sorted out and grown to make the conditioned media.

Could stem cell microneedling producers like AnteAGE be referencing marrow MSCs instead?

How WHYY fails on this coverage

Let’s get back to that WHYY piece on stem cell microneedling that feels more like a feature article or paid promotional piece than solid health journalism.

When you’re talking about a medical procedure, you need to take things seriously as a journalist.

This is not just rubbing some cream on your face, although even there I can see potential risks if you are using someone else’s biological material. The FDA has taken action on that front in the past.

The author Scott doesn’t mention possible risks.

She doesn’t ask questions.

It’s a pretty awful article in my view.

What is this important?

Stem cell microneedling poses risks

Past vampire facial and facelift procedures posed substantial risks of infection. Clinics sometimes reused the microneedling device without proper sterilization. In that way, it risked transmission of pathogens and serious illnesses like HIV and hepatitis. A quote from a news item when this blew up:

“In 2018, the New Mexico Health Department closed a local spa after two cases of HIV transmission were possibly linked to vampire facials. Clients of the establishment had received injection-related procedures.”

Stem cell microneedling like that using AnteAGE products appears to utilize slightly different devices, which perhaps aren’t reused. I hope they aren’t. That would be safer at least on that level. Otherwise, customers may be exposed to each other’s pathogens. You can imagine a microneedling roller device would be hard to perfectly clean for possible reuse with all those needles and spaces where the needles joint stick out from the brush.

Since the AnteAGE device is $120, which isn’t cheap, I wonder if it could be re-used by cosmetics clinics. The device apparently used on Scott per the pictures in her article seems like it might be different than the AnteAGE one, but that’s not clear.

Are customers reusing the AnteAGE device on themselves? That could pose risks without proper cleaning.

Someone else’s biological material

Another issue here is that the bone marrow media material is allogeneic, meaning from another person. This raises risks. From Scott’s piece:

“I’m relaxing in my chair and my face begins to tingle. I’m looking at the treatment I’m about to receive, which is stored in a small vial.  It’s not actual, live cells in there – but the process of creating it does involve human bone marrow stem cells. The company that makes this product, AnteAGE, procures donated cells, then grows and multiplies them in their lab.”

I’m blown away that Scott doesn’t think more seriously about the implications of the product here being someone else’s bone marrow cells. What if that donor has various viruses in their bone marrow cells? Or pathogens somehow get into the mix later? More from Scott:

“What we have in our products is stem cell conditioned media,” says Rob Knight, AnteAGE chief scientist. “We grow the cells in the lab and during this culture they secrete all of their regenerative proteins, growth factors, exosomes into the surrounding media. We can then collect this conditioned media that contains all the active ingredients the cells are producing.”

Is the conditioned media product sterile? If so, does the sterilization destroy the potential benefit of the conditioned media? Many growth factors, exosomes, etc. are not heat stable.

Is stem cell microneedling OK with the FDA?

The fact this product comes from another person raises another potential red flag.

From all I’ve seen, allogeneic conditioned cell culture media is generally going to be a drug. You need FDA approval prior to marketing such things. There’s a good reason for that requirement related to the risks discussed above.

What’s the deal with the AnteAGE product and company?  Their website doesn’t say much. It does mention GMP and donors. They claim their products are pathogen-free. If true, that’s important from a safety perspective.

Is their product a drug and do they need FDA approval? It seems reasonably likely to me, but that’s something the agency decides.

The FDA has taken steps in the past regarding cell-therapy cosmetics. In 2014 it warned Cell Vitals about an allogeneic conditioned media cosmetic product. Still, in the last few years, the FDA has been relatively inactive on stem cell clinics and marketed cell therapy drug products.

I found one blinded, randomized study on stem cell microneedling of the face that is highly cited. It reported some statistically significant improvements when using conditioned media of cells derived from  human embryonic stem cells (hESC) for the microneedling vs. microneedling alone.  However, the magnitude of the changes was minuscule. Note that such conditioned media is likely a drug too so clinical use or even clinical trials probably requires working with the FDA if there is marketing or use in the U.S.. This study was conducted in Korea though.

Cellese and AnteAGE

What do we know about the firm making stem cell microneedling products?

I couldn’t find out much so far.

AnteAGE cites another company called Cellese. There are no Clinicaltrials.gov search results for AnteAGE or Cellese. Neither firm’s website lists actual personnel that I could see at least. They say this, “Based in Irvine, California, our team is regularly published in scientific journals, awarded for groundbreaking results, and sought after for their expertise by Fortune 100 healthcare companies.” Can you tell us more about your publications?

Cellese has a LinkedIn page. The first person there is an Ian S., the President at AnteAGE. There are various other employees. The Medical Director is a George E. Taylor, M.D., who appears to be an anesthesiologist.

Does the production team have outstanding stem cell experience?

Scott says this to end her article, “AnteAGE chief scientist Rob Knight says these treatments will continue to get more effective, as scientists focus specifically on stem cells exosomes, which they believe could harness even more regenerative power.”

Reaching out to the company

Does the firm know that the FDA has defined exosomes generally as drug products requiring pre-market approval?

Who’s Rob Knight?

According to his LinkedIn page, up until a couple of months ago, he was a postdoc at UCLA. I contacted Knight via LinkedIn and heard back. I sent off an email to him including some of the questions I’ve raised here. After a couple of weeks, there’s been no reply. If I do hear back answers to my questions I will add them here as an update or do another post. After a few more weeks, still no reply.

I found other companies doing this as well including something called spfdermatology. 

Finally, the icing on (or under) this NPR cake is striking. Under Scott’s puff piece article, it says this, which seems ironic in this case (emphasis mine), “WHYY is your source for fact-based, in-depth journalism and information.”

References

• Clinicaltrials.gov search results for AnteAGE or Cellese yield no results.
• FDA warning letter to Cell Vitals.
• Paper on blinded, randomized study on stem cell microneedling