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What Are the Bioethics of Sourcing Birth Tissues and Selling Them for Huge Money?

POSTED ON IN Latest News BY Chris Centeno

I was on the phone with a reporter the other day who brought up a great point about the ethics of selling birth waste and consenting mothers. It was one of those moments when you say to yourself, “I never looked at it that way.” So let’s delve into this critical topic.

What Are Birth Tissue Products and Why Should I Care?

Right now, we have armies of chiropractors and unethical physicians claiming that they are using millions of live and young stem cells to treat a myriad of diseases. All of this sounds too good to be true because it is too good to be true. As we and others have found out through advanced lab testing, all of this tissue they’re selling is dead and has no live and functional cells, let alone stem cells. To learn more, don’t just take my word for it, check out my video below that features Lisa Fortier from Cornell:

Selling Birth Tissues as Faux “Stem Cell” Products

First, let’s do some back-of-napkin calculations on how much a live birth is worth if you defraud doctors by selling the birth tissues as “stem cell” products. There are four parts of the birth waste that are commonly sold:

  • Amniotic fluid—the stuff that surrounds the baby
  • Amniotic membrane—this makes up the birth sac
  • Umbilical cord blood—this is found in the umbilical cord
  • Wharton’s jelly from the umbilical cord—this gives the umbilical cord its stiffness

Starting with amniotic fluid, there are about 600 ml of it in the average live birth. Right now, the average price I see per ml if this is falsely sold as a “stem cell” product is about $800. So that’s 600 X 800, which is $480,000! Now that’s the 50th percentile volume, meaning the range goes all the way up to easily double or triple that amount; see below for volumes at 38 weeks:

Hence, on a good day, the amniotic fluid alone, at current street prices, could be worth about a cool million dollars.

The amniotic membrane after it’s been dried and pulverized weighed in at 307 grams in one recent study. We have paid around $800 for 40 mg of dehydrated amniotic membrane. Hence, that’s about seven doses for a street price of $5,600. Hence, it seems like much less can be made by selling the membrane.

The volume of umbilical cord blood donated per live birth in most private cord blood banks is about 60 ml with a total nucleated cell count of 470 million. We know that umbilical cord blood vendors will commonly sell vials of 30 million cells (all dead, dying, or non-functional) at around 2 ml, which would create 15 vials at a cost of around $1,000 each (with some volume waste from centrifugation). So that’s $15,000.

Finally, the Wharton’s jelly is a new tissue being sold, so how much of it is there in a live birth? I found this reference: “At term, in humans, it (the umbilical cord) is 40–60 cm long, with a girth of 1–2 cm.” Here we need to use the volume of a cylinder equation which is V=πr2h. Hence we have 3.14 X 0.75 X 50=117.75 ml. Let’s bump that volume down since only a small part of the cord has the Wharton’s jelly and I’ve seen other references focused on about a 50 ml volume. Again, prices for the 2ml vial of Wharton’s jelly would be in the $1,200 range, so the street price is $60,000. This is the most likely place to find mesenchymal stem cells if we isolated and cultured fresh tissues, but, again, by the time we save it in a public hospital, transport it, process it, freeze it, and then shock-thaw it in a doctor’s office, we have no actual live and functional stem cells.

So what is the likely cost of processing all of this? The cost of donor screening for communicable diseases is commonly a few hundred dollars. The processing time for the lab and bottling would be at most 20 hours and even at $50 an hour (which is likely very high), we have $1,000. Add in another $1,000 for fancy packaging as we want our products to look good. To produce a cGTP processing lab required by an FDA 361 tissue registration, the total cost is well under 100K. If you amortize the cost of a lab at $1,000 per processed live birth, that would work fine from a business standpoint. You also need to advertise and go to trade shows, so let’s take $10,000 per live birth to move the product. Finally, if you add in having to pay a sales rep, that would eat about $10,000 per live birth for salary plus about 15–20% off the top. Throw in a few employees and rent at $20,000 a live birth, just to be generous.

So what is a live birth worth to a company that processes, advertises, and sells this stuff? On the positive side of the ledger, we have:

  • Amniotic Fluid: 480K
  • Amniotic Membrane: 5.6K
  • Umbilical Cord Blood: 15K
  • Wharton’s Jelly: 60K

Total retail price: 560.6K

Now on the negative side of the ledger:

  • Sample Testing: 0.3K
  • Processing and Bottling: 1K
  • Packaging: 1K
  • Amortizing the Lab: 1K
  • Advertising and Trade Shows: 10K
  • Sales Rep: 10K salary plus 15% of retail price: 67.1K
  • Employees and Rent: 20K

So our net profit here per live birth is 560.6K-100.4K=460.2K! So let’s say the range is between 400–500K profit per birth. That goes way up if we get more amniotic fluid, and that goes down for waste or perhaps additional lot testing, a more expensive lab, or more expensive employees. However, this crazy profit margin brings up a critical point. How much of this money is the birth mother getting?

An Ethical Conundrum Brought Up by a Reporter

I told a reporter on the phone that I thought a live birth could fetch upward of a million dollars retail. As you can see, I wasn’t far off, as if we get a higher volume of amniotic fluid, we’re at that price pretty easily. She brought up a great question, which I’ll paraphrase: Is the birth mother getting some of that so she can put the kid through college?

Who are these birth mothers? We can use some logic to get to a likely conclusion. These days, in every private hospital, umbilical cords are being saved by suburban parents for a fee. Hence, it’s unlikely that the average middle income or upper-middle-class couple is donating their birth tissues as they’re saving them for their own kid. Hence, it’s more likely than not, that most of these tissues would come from public hospitals, where such business ventures for cord storage are much less common.

So who are these mothers? My guess is that they’re low income, poorly educated, and the least likely to have any idea that the waste from their birth could fetch some company a cool half million bucks or more. Hence, what are the ethics of the mothers not understanding that their tissues are being sold for huge bucks? What does the consent process look like? Are the mothers just handed a huge mass of forms to sign about their procedure risks and tucked in there is a consent to donate their birth tissues?

The upshot? My guess is that these poor and uneducated mothers have no clue that their birth tissues are about as valuable as gold in the private marketplace of scam stem cell product sales. This is definitely a topic for real university bioethicists to ponder and review. At the very least, some smart journalist needs to go undercover and find out what happens in this consent process and how this industry is able to source and sell these highly valuable tissues.

 

    *DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.
    Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.

    comments

    Cheryle Darley says

    I distinctly remember how excited the delivery nurse was over the 'long, healthy umbilical cords' from my birth of each of my three children and the fact that I agreed to donate them when asked by the nurse. I would have donated them to research, but not to defraud people whom believed it would help them with their personal health issues. If they are sold to companies that follow ethically proven uses, the hospital should compensate the family the majority of funds from the sale, taking only a small handling fee - college for our three kids cost us over $350,000!

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    Bradbury Franklin says

    THIS!!! I have asked this question of several umbilical stem cell providers as I evaluate my options. I am DEEPLY TROUBLED by their responses. They CLEARLY HAVE INCENTIVE to clamp the cord PREMATURELY AS IS COMMON PRACTICE.

    COMMON SENSE and SCIENCE suggest babies need to have all of their blood. Iron levels are shown to be higher and you CAN'T get IRON from breastmilk because breastmilk is iron poor to protect baby from infection. It's crazy how evolution figured this out. Animal primate moms take a long time before they deal with the cord. Hours usually. Not seconds or minutes.

    VERY TROUBLED by compromising the health of the next generation for the profit of this one.

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    Salahudeen says

    Dr. Centino, well articulated!! I respectfully disagree the points on the pricing. No country in the world charges 5 6k Dollars for 10 sittings of amniografts. Here in India or be it any nation with developed infrastructure to have ability to process these samples have come out with not more than 50-100 dollars pricing, except that in US people are cheated by exorbitant pricing of such products!!

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    Patrick Ess says

    I agree with Salahudeen. Americans are gouged in the healthcare arena. I think even Dr. Centeno would agree to that.

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    Regenexx Team says

    Hi Patrick,
    It's a broken system... Please see: https://www.regenexx.com/blog/medical-care-system-broken/ and https://www.regenexx.com/blog/regenexx-makes-sense-company/

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    Patrick Ess says

    I am also interested to know what Dr. Centeno thinks the benefit of saving your own birth waste is since everything "all of this tissue they’re selling is dead and has no live and functional cells". What good could it possibly offer?

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    Regenexx Team says

    Patrick,
    Banking cord blood in private cord blood banks is currently allowed to be used for various blood cancers for the child whose birth it resulted from and first and second degree family members for whom their is a match.

    replies

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    About the Author

    Chris Centeno

    Christopher J. Centeno, M.D. is an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. He is board certified in physical medicine as well as rehabilitation and in pain management through The American Board of Physical Medicine and Rehabilitation.…

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