In today’s post I review the cord blood firm Cryo Cell International and discuss specific concerns I have about it.
A major issue is their plan to open a clinic selling unproven cord cell infusions to kids. I believe this is risky both for the firm and more importantly for the children.
What is Cryo Cell? | Dubious cord cell therapies | Risks | Cryo Cell reviews | Stock and future of the company | References
What is Cryo Cell?
Cryo Cell International is a private, for-profit cord blood banking firm.
Cord blood banking companies store umbilical cord blood for potential future use. The blood is kept frozen in large liquid nitrogen freezers, where the cells are stable for decades if conditions are ideal.
Cryo Cell seeks to get more involved in clinical research in coming years.
A more specific goal is to evolve into generating a substantial amount of revenue in a new way via unproven cord blood infusions of children. This means that they would go beyond just storing cord blood to administering it as a therapy. That would be a huge transition. Can they pull it off?
Dubious cord cell therapies
My main concern with the firm is this relatively new plan to sell unproven cord blood offerings to children.
These would be administered via an infusion clinic based on a partnership with the Duke Autism Center. While different conditions would be treated, a main focus is going to be on autism.
The big problem here is that there is no evidence that cord blood infusions help kids with autism. There is also no evidence that these infusions would help cerebral palsy or other neurological conditions in children, which also apparently will nonetheless be marketed.
Risks from the infusion clinic plan
We also have to think about risks. While cord blood infusions are generally safe, there are risks to what Duke and Cryo Cell are doing and plan to do.
For instance, children can have infusion reactions after getting the cord cells.
Also, some children that Duke has already been infusing based on an FDA cleared expanded access program have been sedated in order to get the infusion. That sedation brings its own risks. Since there is no clear benefit of the cord blood infusions, is the rather intense step of sedating children ethically justified?
I’ve written extensively about my ethical and policy concerns with this Duke Cryo Cell collaboration. I believe this clinic plan would take advantage of vulnerable kids and their families. Beyond the risks to the children’s health from the infusions, the team’s efforts give a hit to family finances.
The main goal seems to be to generate tens of millions of dollars in revenue, which would come from the families of the kids.
Overall, I don’t see much of an upside for the children and their families.
Cryo Cell reviews
Clearly, I have strong views on Cryo Cell and the Duke Autism Center. What about other reviews of Cryo Cell?
Looking on the Better Business Bureau website, Cryo-Cell has generated quite a few complaints from customers. One of the main issues seems to be when patients want to cancel the service.
On the positive side, many of the complaints have been resolved.
The firm also has very positive reviews on Yelp overall, but I don’t see any reviews of any kind since 2020.
When searching for Cryo Cell on the web, the website Glass Door popped up. The reviews from employees are very mixed. Some strong opinions both ways.
An article in Motherboard details additional concerns on the Cryo Cell – Duke clinic plan.
CCEL stock and future
The firm has had a rough time in terms of its stock lately.
The price is way down. See the above chart for Cryo Cell, symbol CCEL.
Overall, I’m not that optimistic about the firm’s future. Much depends on whether Duke researchers can finally generate some kind of encouraging results with cord cells in clinical trials. That could happen, but so far the trial results in my view have been almost completely discouraging.
It’s very possible that in the long run Cryo Cell will remain mainly a cord blood banking firm.
I have called on the FDA to freeze the expanded access program for cord cells for autism at Duke, which is the foundation for the new infusion clinics since what they are offering is unproven. In the year since I called for the freeze, I have not seen any news about the program.
Cryo-Cell now aims to open the first infusion clinic next year.
References
- New York Times article on cord blood banking.
- Motherboard article on the controversial Cryo Cell – Duke plans for one or more clinics.
I fear we’ve missed the bit of brilliance in the expanded access program: https://www.clinicaltrials.gov/ct2/show/NCT03327467
“Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries”.
Alas for all the experts who say autism is a developmental disorder. Maybe Dr K. could enlighten them as to why autism is a brain injury.
Kindly update cord blood Iv infusion autism .
I agree with Bill and Dr Paul’s reply(s) above as applied to essentially all these pay-to-treat clinics who use IV drip or “injection into the blood stream” methods. They “claim” and in some videos provide supposed “explanations” that say, “You see, these cells have magic homing pigeon like abilities to seek-out inflammation and damaged organs or whatever needs healing. So, when dripped into the bloodstream, they go to the area needing help and repair it, cause you know, it just sounds so good as these are stem cells or variants thereof, POOF, it’s magic” blah blah. They said this with SVF, now with this “Autism thing” that I guess it homes-in on the brain and does what exactly to cure Autism, via who the heck knows what mechanism etc ? My first question always was this hypothetical then: IF I went to the clinic for say COPD which many of them “treat” using SVF in a IV or even nebulizer, AND they claim it “Has homing ability to seek-out the damaged cells, the inflammation they say is the root of almost all illnesses and these new cells then go to work to repair said areas of damaged cells” blah blah. My question/hypothetical was always this then: “The DAY BEFORE I’m due for my magic COPD IV treatment (as just one expample of an ailment) – I drop a big hammer on my foot that night before and really cause it to swell, and it’s got maybe a broken toe, is burning hot red and sore as I really dinged it up” etc. SO, please explain to me in great, great scientific detail HOW do these magic cells now, not all flow via the IV and rush down via my bloodstream to my now inflamed and burning red hot busted up foot and toe, vs deciding that “No”, we’re on a mission to them damaged lungs and fixing that there COPD ?? I could never, ever understand that, nor have I ever found an explanation using science that can explain it to me at say a Jr High school student level with any credibility. HOW, how do these cells or in the Autism case the cord blood whatever – how does it know to “hunt, to seek out, to ONLY go where they claim it goes” to cure said ailment ? When they can explain that and show the science (scans w/ tracers using nuclear medicine as one example, live MRI to show the brain being altered for Autism in real time as this product is IV dripped into the patient or the traumatic brain injury many claim to treat and cure, or stem cells with tracers embedded in them via live MRI “flowing” to the lungs only for COPD as an example) when they can show ANY of this to actually be “happening” as they claim, then I might begin to accept and possibly believe it. Else, I see this “stuff”, being dripped in via IV as doing nothing but mixing with one’s blood and having no known mechanism of action other than diluting the blood and being excreted likely via urine or just being absorbed and vanishing via any number of bodily function processes (wouldn’t just blood pH and/or the immune system likely render these cells dead anyways in most cases ?) . And unlike say saline or glucose or lactated ringers in an ER IV (or during Chemo etc) which are a substance, a part of the elemental chart and not a “live biologic” trying to mix and flow through one’s blood – those added substances with typically just pure water as their base carrier, they provide hydration or blood volume or shock prevention/suppression etc, there is NO plausible mechanism I can see or find for “Live Cells in an IV drip by magic finding and curing an ailment in some other organ or remote part of the body via homing in on it” – I just don’t buy it, nor see any real science to support it.
@Rick, you raise a lot of good points and questions. The cord blood for autism folks don’t have good answers. They keep changing their stories too. In the bigger picture, you’re also right to be skeptical of IV “treatments” for lungs and other conditions that rely on a largely hypothetical homing of stem cells to injured tissues. While there is some limited evidence of stem cell homing to sites of damage, it’s not going to happen in a very broad way. A lot of that work was done in mice too.
As someone who has been following this stuff for a decade or so, it seems like many people selling stem cells personify them. They make the stem cells out to be like these smart entities who are on a mission and just know what to do and only do good stuff.
In terms of stem cells by IV and the lungs, one reason why some stem cells do sometimes end up in the lungs after being put into the blood is that the lung capillaries catch random cells that aren’t supposed to be in the blood. Macrophages in the lungs likely eat and kill most of the injected cells from clinics that are trapped that way. Macrophages in the liver probably do too.
Do we know how they plan to get around the existing patents and patent applications pertaining to cord blood and autism?
I really dont see a BLA coming out of this …and one cant just go and “set up an infusion clinic”…..or then again …who knows….while people like me have to go through the FDA process ….there are so many “knowledgeable doctors” that just seem to be practicing “stem cell medicine” with no consequence.
Perhaps the Duke group has had some friendly folks inside FDA leadership over the years?
Besides being a therapy unapproved by the FDA and therefore illegal I fail to understand why giving recipients blood back to them would effect changes in brain structure associated with autism.
Well, Duke has that expanded access program that seems to allow charging. Their rationale has been all over the place over the past 10+ years. First, the cells do enter the brain and do good stuff. Now it has evolved to some kind of vague perhaps systemic immune modulation function that somehow helps autism (and CP, etc). Also, first it was that whole cord blood would work, then the MSCs in cords, and now maybe it’s the monocytes or other cells…or maybe it is the MSCs but you have to grow them first. Who knows, but cord blood must help autism. That’s the dogma to prove. In the meantime what about the 100s of children (1000s in the future?) who have been experimented on and their families that have paid or will pay millions of dollars? And on top of it all the clinical trial data the team generates is negative but still the work must go on? As I’ve said before, the FDA needs to halt that expanded access program.