Celling Blog

Autologous Stem Cell Medical Devices

Amniotic

June 30, 2016

Full of Meconium III

I have been exploring over the past couple of posts (here and here) the ingredients that can be found in the latest miracle cure regenerative therapy: amniotic fluid without micronized placental tissue. I have focused on the website content of Regenerative Processing Plant (RPP), a company offering an amniotic fluid product. I had just finished with RPP’s claim that proteins in amniotic fluid are immune privileged (which makes no sense to me). RPP implies that their laundry list of proteins and extracellular matrix constitute what the company refers to as the mixology of stuff that does great things. – Read More –

June 28, 2016

Full of Meconium II

In the last post I provided an excerpt of some of the language I found on a website for a company called Regenerative Processing Plant (RPP), which markets a product that contains only amniotic fluid, in contrast to other injectable products that are made from micronized placental tissue. It seems to me from what I read on their website that the RPP product itself doesn’t contain any micronized placental tissue, so micronization of placental tissue isn’t an issue. On the other hand, there are a number of other issues I believe the FDA could raise with the company concerning statements on their website, but I won’t dwell on these potentially problematic faux pas. – Read More –

June 23, 2016

Full of Meconium I

One of my duties at Celling Biosciences is to interact with physicians who seek information about the whole “regenerative medicine” thing. Of course, the advantage for me is that I get to hear what sales reps are telling these physicians about the various products that the doc should be using to provide “stem cell” therapy in their practice. Much to my dismay, but not my surprise, the information the physicians say they were provided frequently turns out to be incorrect and/or blatantly misleading. – Read More –

November 12, 2015

Homologous Use Draft Guidance IV

In the last post (111015), I had finished reviewing examples of what the FDA means when it mentions the function or functions of HCT/Ps in the context of the draft guidance on homologous use it issued the last week in October. I will continue with a review of additional elements of the draft guidance, including one example that isn’t so humdrum (the term I used previously to describe the quality of the examples the FDA has included in the draft guidance).  – Read More –

July 2, 2015

The Rest of Bio D’s Untitled Letter

In the previous post, I began a review of the Untitled Letter the FDA issued to BioD, LLC last week. I will conclude my review in this post with a couple of observations summarized as follows:

What the FDA didn’t cite is quite intriguing: no issue with descriptive language in statements the FDA referenced in the Untitled Letter from product literature and off the Internet; and no issue with the viability status of any cells that might be present in the processed placental-derived tissue, from which I conclude that all of the intact cells are dead.  – Read More –

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