√ Just One Word: Placentas. Can Biotech Celularity Live Up To Big Hype?

I’ve been blogging about stem cells now for about 8 years and the recent level of hype about and fluffy media coverage of Celularity, the biotech spun out of Celgene, ranks right up here with the most extreme past cases I’ve seen.

What is Celularity and who is its leadership?

It’s a new biotech focused on placental stem cells with some familiar, well-known leaders including Bob Hariri and Peter Diamandis, and famous tech names on their board including John Scully and Bill Maris, along with past FDA Commissioner Andrew Von Eschenbach. And this company expresses some big aspirations via stem cells.

• Extend human life by decades.


• Fight cancer through CAR-T cells.


• Treat Crohn’s disease.


• And much more.

And this all will be achieved through the apparent unprecedented power of one particular kind of cells: placental stem cells.

You can see a screenshot below of just some of the media coverage popping up on Google News.

The statements by Celularity’s leadership are not just ambitious in terms of the types of conditions and diseases to tackle, but also the short sasaran timeline to take them to patients. For example, FierceBiotech has this surprising quote:

“Hariri said that the company “anticipates rolling treatments out through partner clinics within the next four years,” although he says that timeline “may change” as it collects more data.”

Just four years? That would seem to necessitate not getting an IND from the FDA or going through the clinical trials process.

What exactly are these partner “clinics”?

To my knowledge, placental stem cells are going to require an IND (wouldn’t their isolation from placenta likely be a drug manufacturing process? And the cells are going to be used in an allogeneic manner by definition, their uses are almost always going to be non-homologous, etc.) so how can they start selling them through clinics in just a few years? I hope that particular plan, should it materialize, won’t be like the stem cell clinics out there that transplant cells into patients without FDA approvals.

Overall, could the company be at risk of overselling placental stem cells? This other quote from the FierceBiotech piece might suggest so:

“When asked what evidence the company had that a placenta-based therapy could work, Hariri responded: “The placenta is the most powerful resource known to medicine.”

By chance, I happen to help teach about placenta in our med school histology course so I know a fair amount about it. Placenta is a cool tissue and somewhat unexplored territory relative to other organs. It has some unique immune properties as well. In addition, Hariri also has quite a few interesting research articles (note that a few of these articles on PubMed may be by someone else with a similar name) on placenta and other related materials. However, placenta is the most powerful resource known to medicine? Why?

This placenta buzz related to Celularity reminds me of the famous scene in the movie The Graduate where the older guy gives the young man played by Dustin Hoffman advice about the future “Just one word: Plastics.” (see clip below) But here with Celularity and its media coverage, the quote would be “Just one word: Placentas!”

Unfortunately, FierceBiotech’s piece misses the boat on some of the science here with statements like this, which isn’t a quote from Celularity, but is just stated as fact:

“Unlike embryonic stem cells, placental cells are incredibly pure, meaning they can be taken from any placenta and injected into any human without the risk of the body rejecting them.”

What is meant here by “pure”?

Unlikely to trigger an immune response?

To me as a stem cell biologist this seems like an odd word to use in that context. Purity would refer properly to homogeneity. Also, getting back to the immunity idea, it is debatable at best to make a blanket statement that placental stem cells have no risk of rejection in any human into which they are injected. That’s very unlikely to be the case so broadly.

Practically speaking, it turns out that Celularity not only has $250 million in capital, but also owns the stem cell bank firm, LifeBankUSA, which apparently can generate millions in profits to serve as fuel for Celularity’s many other efforts. This gives them a leg up on many otherwise similar stem cell biotechs.

Notably, some of the media coverage of Celularity has been more balanced including this piece by Matthew Herper, which appropriately ends this way:

“Those are big promises. At the least, it won’t be boring.”

We’ll have to see how things turn out, but the overall hype here has raised expectations so sky-high that they’re going to be difficult if not impossible for Celularity to meet. As Herper said, at least it won’t be boring to watch Celularity’s efforts.

Sumber aciknadzirah.blogspot.com

√ Sales Of ‘Zombie’, Birth-Related ‘Stem Cells’ Continue To Mushroom

The birth-related stem cell clinic industry is a serious dilema for patients, the stem cell field, and the FDA as the clinics sell more and more of what I think of as “zombie” injections.

One of the biggest changes in the last 2 years in the unproven stem cell clinic arena was predicted by the data that Leigh Turner and I published in one of our collaborative papers in which we saw an upward slope in the number of businesses selling amniotic or other birth-related “stem cells”.  By “birth-related” I mean amniotic, placental, umbilical cord, or other products that result from the birth of a new baby.

The numbers were still very small at the time of our study, but the ekspresi dominan was clear. Still, at that point I wouldn’t have guessed that we’d find ourselves in early 2019 with a massive number of clinics selling birth-related “stem cells” from coast to coast. There could easily be 100-200 of these clinics or other individual practitioners selling this stuff. Why the big growth here? Suppliers and marketers are driving the expansion by convincing chiropractors (and some physicians) to sell their unproven and non-FDA approved products.

I speculated in a post “Wanted Dead & Alive” a couple of years back that some for-profit clinics and suppliers in this area are selling products that aren’t really living stem cells (they are “dead” extracts), but they still market the products as both living and stem cells. Hence, there’s my opinion that this is a “zombie” kind of thing.

To be clear, some birth-related products (when not in vague “zombie” form, but instead produced in appropriate clinical-grade facilities by experts and validated to contain living cells of defined types) are promising for certain applications and are being studied in many clinical trials, but should not be sold today.

There are big, unanswered questions here. For instance, where do the birth-related products come from? How often are they either be contaminated or have not been probably tested for pathogens? Do the new mothers know that the materials from the births are being sold and possibly resold? Is it possible in many cases mothers have not consented to the use of the brith-related materials?

Also, could some of the products sold in the US be produced from overseas births? I have heard this is likely the case for some suppliers, but I haven’t seen concrete evidence of this. The lack of clarity about the sourcing and validation of birth-related products being widely injected into patients is very worrisome.

For instance, in the last few months we learned that 12 people were reportedly hospitalized due to contamination of a birth-related product being marketed by Liveyon and apparently produced by another firm called Genetech (not Genentech). Somehow the product became contaminated (or was contaminated to start with?) with various kinds of bacteria before it was injected. Fortunately for other potential patients, the product was recalled by the FDA.

This doesn’t seem to have made much of a dent in this birth-related “stem cell” clinic sector so far, but we’ll see. There also have been at least two and perhaps more patient lawsuits against firms in this area. I expect that number is already growing and that could rein things in somewhat too.

The FDA needs to get moving in this area since the products are marketed as living cells, which in allogeneic form and often used in a non-homologous manner would be unapproved drug products. If there are no real living stem cells in most of these products as many of us suspect, then the FTC needs to take some action here quickly too.

Paradoxically chiropractors are the primary ones selling birth-related ‘stem cells”, even though they themselves cannot legally inject them. In my opinion, these chiropractors pitching stem cells are essentially working with suppliers and physicians to just extract more money from their client base, without a reasonable expectation of benefit to the customers and with definite risks. Chiropractic associations needs to take some kind of major action here.

Overall, how do we get out of this zombie, birth-related “stem cell” mess?

The possible solution seems to be a combination of educational outreach to patients/consumers and bold action by multiple levels of regulators. It’s not encouraging that in the fat stem cell clinic arena, which is even bigger as well as being years older, and has some major problems of its own including hurt patients, we haven’t seen this kind of big impact yet by regulators.

Sumber aciknadzirah.blogspot.com