In the stem cell world some corporate names end up being very similar with the latest example being several companies with the name “BioLife.”
Get a BioLife…name
I guess BioLife is a catchy term. You’ve got life and biology in there in one name.
Let’s deconstruct what’s going on out there with this corporate name. I’ll cover the one that is concerning to me first.
Boston BioLife
The first one is Boston BioLife. Years ago, this firm suddenly started appearing in my email inbox. I had been added to an email marketing list it seemed. What concerned me about some of these emails was the marketing in there of courses on unproven stem cells. Also, other unproven regenerative offerings were in the mix at times.
I’ve seen at least somewhat less of that now in their emails, but in my opinion it’s a real concern overall.
This organization seems to be a go-to for unproven stem cell clinic and regenerative clinic folks.
For instance, in 2018 Dr. Doug Spiel mentioned Boston BioLife on his website. Spiel has received an FDA warning letter related to marketing or use of unproven exosomes. This included some kind of unapproved stuff for COVID-19.
Training courses, but what about FDA compliance issues?
In January 2021 I received a marketing email from Boston BioLife. See a screenshot above of part of it. In my view there are several problems with this marketing. For example, there are no FDA-approved uses of PRP or exosomes for joint injections, hair injections, etc. In addition, the FDA has said that exosomes are drug products requiring approval before use.
So how can a firm be offering training in joint injection, hair restoration, etc. with exosomes if they are unapproved drug products?
I don’t know the answer.
These training courses remind me of others I’ve seen over the years. Some stem cell training courses have been quite concerning and overall I worry about this kind of thing enabling stem cell clinic firms to take risks. Short courses are not a sufficient basis to start a medical practice based on stem cells or other biologics.
I’m all for rigorous physician training in stem cells and regenerative medicine. We’re talking about a year or two of training from experts that includes FDA compliance. In 2013, I was the first or one of the first to put out a call for stem cell training programs like this. Thankfully, some now exist, but they are light years different than a weekend course (sometimes including the golf course) on stem cells, exosomes, etc.
Boston BioLife twitter
Sometimes it’s helpful to check out a firm’s Twitter feed.
In the case of this firm, I noted Boston BioLife frequently retweeting tweets by Bioinformant, a stem cell marketing firm that sometimes appears to do marketing for unproven stem cell clinics.
Bioinformant has also covered BioLife on their site.
Company 2: BioLife Plasma
I was less familiar with a company called “BioLife Plasma” so I did some research.
They are a plasma donation and supply firm.
I don’t see any particular concerns about this firm related to regenerative medicine.
Company 3: BioLife Solutions
I found another firm with the same shared name component. BioLife Solutions.
This one is regenerative medicine-related firm and very different than the other two.
For one thing, it is a big company on the NASDAQ. They describe themselves as a, “leading supplier of class-defining cell and gene therapy bioproduction tools and services.”
They help other firms properly freeze their regenerative products including stem cells. I’m guessing some academics may use their services too. Properly thawing frozen cells is also crucial and they have products for that as well. This is an important area. We freeze and thaw cells in our lab all the time and occasionally the cells don’t bounce back well.
More generally, I found a variety of other firms and products that have the “BioLife” name.
References
Call for fellowship programs in stem cell-based regenerative and cellular medicine: new stem cell training is essential for physicians, Paul Knoepfler, Regenerative Medicine, 2013.
BioLife Solutions Inc. is extremely well known, widely used, and respected in large portions of the cellular therapy world. Its cryoprotectant is often cited as the gold standard of cGMP Cell Freeze Media. They have a robust supply chain, excellent communication, knowledgeable staff, and operate with a high degree of ethical integrity. They are in many ways the polar opposite of what we often discuss on this blog.
If you are an academic looking to remove any variable related to home-grown cryoprotectants, use them.
The Interventional Orthobiologics Foundation(IOF) is a not for profit organization that is dedicated to education/training, ethics and guidelines in the use of Regenerative procedures for orthopedic conditions. They have a very rigorous and standardized educational curriculum with various levels of hands-on education from beginner to more advanced training. One must be pre-qualified to take the advanced course. Pre and Post course testing is performed to assess proficiency.