During a course offered by ASIPP last March in Las Vegas, NV, I gave a brief impromptu presentation about regulatory issues in the field of translational regenerative medicine. I mentioned that producers of placental tissue-derived products, like amniotic fluid products or amniotic fluid plus micronized amniotic tissue products, were sprouting like weeds, despite the issuing by the FDA of an Untitled Letter to BioD. One of the participants mentioned that BioD subsequently had gone out of business. However, since profits spring eternal, a number of other companies seem to have rushed in to fill the void.
Frankly, I am not sure the newcomers are any different from the older, established companies, like BioD, since all BioD had to do was sell the inventory, trade secrets and manufacturing documents to “new” owners, who subsequently could set up shop down the street (or even at the same physical address), register the new entity with the FDA and be back in business within a matter of weeks. Mind you, I am not saying that anything along those lines occurred with the remnants of BioD, but the processing of placental tissue-derived clinical tissues is fairly well established. And quite profitable, so much so that even if you only get to sell amniotic products for three years before being called out by the FDA you end up with a lot of money in the bank.
Since learning of the demise of BioD last March, I have seen comments from physicians reporting on the appearance in their in-boxes of advertising slicks touting the benefits of amniotic fluid-containing products. Eventually, my boss, Dr. David Karli, received one and shared it with me.
Normally, I would provide full details on the contents of the blurb, starting with the company name and name of the product. However, after providing comments to the sender of the marketing blurb, I was informed that some of the content would be re-written to reduce their chances of becoming a whack-a-mole candidate with the FDA. All right, the company representative actually didn’t say the whack-a-mole bit, but that is what was implied.
Consequently, and somewhat out of character, I will back off on providing explicit statements reflecting the content of the blurb, so you will just have to accept that my paraphrases are accurate. The blurb for the amniotic-derived product contains a lot of self-serving claptrap starting with their bold statement that the product meets the criterion of minimal manipulation and also is designated as a `361-compliant material.
This particular limited view of 21 CFR 1271 is entirely self-serving, since there are a couple of other elements of 1271 that I seriously doubt their product complies with, which means it is not a `361-compliant material. For example, the amniotic-derived material is cryopreserved, a processing step not required unless the goal is to preserve the viability of nucleated cells present in the product. If viable cells are present, and the product isn’t restricted to the treatment of first and second degree relatives of the donor, the product isn’t compliant with 1271.10(a)(4)(i and ii).
While I inferred non-compliance of the amniotic-derived product from their use of cryopreservation, reading along in the marketing slick brought me to a statement in which MSCs were mentioned in a way that implies they are present in the amniotic-derived product, since the MSCs were described as being multi-potent, and able to differentiate into a variety of different types of cells. The blurb waxed especially enthusiastically about the prospects of the MSCs being able to trans-differentiate into various kinds of vital progenitor cells useful for fixing whatever ails the patient. But, somehow, the donor-derived MSCs providing all of this vital healing power aren’t in violation of 1271. Furthermore, I suspect marketing folks have been reading one too many scientific papers without the benefit of really understanding what was being said. Unless I missed a tsunami of a research publication to the contrary, the current thinking in the regenerative medicine community is that MSCs function mostly as a source of important biochemicals that influence the activities of existing tissue-based stem cells and the adult cells found in virtually every tissue of the body.
According to the marketing blurb, the other claim to fame of the amniotic-derived material is that it contains conditioned medium taken from the culturing of MSCs obtained from the amniotic tissue or fluid, since both materials are known to contain stem cells of one sort or another. Now, this is very interesting, since I previously hadn’t seen a product that contained conditioned medium.
I will complete my review of the ways I believe this particular amniotic-derived product is not `361-compliant in the next post.