A firm called Utah Cord Bank has been in the news related to stem cell clinics over the past year or two. Now they have received an FDA Warning Letter for a variety of manufacturing issues.
Utah Cord Bank Background
In terms of some brief backstory, Utah Cord Bank first popped up on my radar about two years ago.
They seemed to supply non-FDA-approved birth-related products to clients that included different unproven stem cell clinics.
A piece by Caroline Chen over at ProPublica around that time put a bright light on this company and the background of its founder, Eliott Spencer. I recommend that as a good source of background.
Blogger Derek Lowe then also wrote a piece in part about Utah Cord Bank.
I covered that development here on The Niche.
Lowe later reported getting a lawsuit threat over his blog post.
Unfortunately, that’s not too uncommon when writing about stem cell clinic firms or suppliers.
The Utah Cord Bank FDA Warning Letter
Since that time it seems the FDA has taken a closer look at Utah Cord Bank.
The agency inspected the firm, issued a 483 inspection report, and now sent them a warning letter. It is addressed to Eliott Spencer.
The letter includes a long list of issues related to failures in manufacturing practices. Here are just a couple of the things flagged by the FDA:
You failed to validate your microbiological testing, which cannot be fully verified, used in the manufacture of HCT/Ps to ensure that your process prevents the introduction, transmission or spread of communicable disease through the use of the HCT/P.
Failure to adequately monitor environmental conditions and provide proper conditions for operations, where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents [21 CFR 1271.195(c)].
I find these kinds of issues particularly concerning because of the whole Liveyon fiasco. In that case cord blood products were contaminated with different strains of bacteria somehow. Injections with that product sent about a dozen people to the hospital.
Perinatal products (umbilical cord, amnion, and placenta) have a high risk of being contaminated with pathogens during labor and delivery. Such risks are much higher than with bone marrow or adipose stem cells. Rigorous testing and documentation of these kinds of birth-related products are crucial.
Utah as stem cell supply hotbed?
Oddly, as I’ve written before, quite a few Utah entities seem to be supplying clinics with materials.
Predictive Technology, a Salt Lake City-based publicly-traded firm ($PRED), also has raised some concerns on the stem cell front and got an FDA warning letter too.
In another more recent situation, Missouri state lawmaker Patricia Derges was arrested for stem cell clinic type activities. Her supplier apparently was the University of Utah, which had cautioned her that the product did not contain living cells. I’m still trying to understand why the University gave her the material in the first place.
An all-important footnote from the FDA
The agency also included a footnote that caught my attention:
“This letter applies solely to products manufactured for autologous use or, depending on your response to FDA’s request at the close of this letter, any products manufactured for allogeneic use in a first-degree or second-degree blood relative. Accordingly, references in this letter to HCT/Ps or “products” do not include products manufactured by your firm that are not for autologous use or allogeneic use in a first-degree or second-degree blood relative. FDA intends to communicate with Utah Cord Bank, LLC separately regarding these products.”
It’s striking that the FDA is going to contact Utah Cord Bank separately about those. It sounds to me like a possible additional big headache for them.
Many stem cell clinics sell birth-related products that do not fit the criteria mentioned by the FDA in the passage above. Such products are generally used in an allogeneic fashion and are drugs.
Can the stem cells from this clinic cause GVHD?
It’s hard to be sure.
This piece might be helpful for general perspectives on this: https://ipscell.com/2020/02/patients-stem-cell-qa1-can-clinic-injections-cause-gvhd/
An important question is whether the stuff sold by cord blood suppliers even has living cells. In some cases there’s a sense that the material may be “dead.” On the one hand it’s bad if there are no living cells inside since customers are paying for it assuming there are cells. On the other hand if there are no living cells, that means less chance for some side effects like GvHD or tumors. You need living immune cells from someone else to have a chance of GvHD.
I see. Thank you so much.
For an update on the leisurely pace of California regulation of the rogue clinics, see this piece on the California Stem Cell Report. You may want to forward it with or without comments to the state medical board and your California state legislators.
https://david293.substack.com/p/feds-step-up-action-against-rogue
So the use of autologous or allogenic (1st/2nd degree blood relative) is handled separately by the FDA under 361. There is still a lengthy list of Federal Regulations that apply here. If they are working on non-autologous or non-1st/2nd relative use then that falls into the 351 side of the equations, aka you need a BLA… which is what most people believe this manufacture is doing. As such the FDA has to take a whole different approach. The FDA probably went in think it was inspecting one thing, and then figured out what they were inspecting was a very, very different.