BioRenew® PTM Therapy™? Ugghhh! I Can't Keep Up!
POSTED ON 8/26/2018 IN Research BY Chris Centeno
I can no longer keep up with the new stuff online claiming to involve stem cells and regenerative medicine. It's officially out of control. However, my inbox continues to be pinged with new information almost daily. The newest I have seen is BioRenew® PTM Therapy™. What's this? A re-branding of the same old placental tissue you have seen here before, but hidden under many layers in a website. Before I launch into my review, it's important to note that nothing that I will find out about BioRenew® PTM Therapy™ will be new. In fact, the issues I will show you with outcome data could apply to many different websites advertising many different "stem cell" therapies. In addition, the confusion surrounding the regulatory status of this product and whether it contains stem cells is also not unique.
From looking at the main BioRenew® PTM Therapy™ website and more digging on the web, it's clear that this product is placental based and made by Skye Biologics. What are amniotic and placental products? Why would they work to help repair tissue? These are made from the sac and/or fluid that surround the baby. They are collected and processed and bottled, and some are dehydrated and some frozen. After transport, processing, freezing, transport, and being shock thawed at a clinic, they are all dead tissues and they are regulated by FDA as such. Despite this, you will see many companies and providers claiming that these are live and functional stem cell products. To learn more, see my video below:
These products do contain growth factors, which are substances that can help with tissue healing. However, the concentration of most of the growth factors that we know to be important for orthopedic healing in these placental products is lower than one would find in the patient's blood platelets. Hence, using platelet-rich plasma from the patient generally makes more sense. Having said that, there are clinical scenarios when we do combine these amniotic/placental tissues with PRP or real bone marrow-based stem cell procedures.
The BioRenew® PTM Therapy™ Website
First, it took some digging, but the website seems to be an advertising tool for a placental product. This statement is made: "NOTE BioRenew Therapy make no claims concerning the biological properties of any product or potential outcomes as a result of the use of any product. Information on this site is provided for informational purposes only and is not meant to substitute for the advice provided by your own physician or other medical professional. The results reported may not necessarily occur in all individuals. BioRenew Therapy is providing this site and its contents on an "as is" basis and makes no representations or warranties of any kind with respect to this site or its contents. All tissues have been collected, processed, stored and distributed in compliance with FDA regulations governing HCT/Ps." Why is this here? This is an FDA 361-registered tissue product. There is no FDA approval based on any clinical trials, but instead, this is a 45-minute quickie product registration on the FDA website. Hence, the manufacturers of these tissue products aren't allowed to make ANY clinical efficacy claims. They are only allowed to state the following:
- I have this tissue for sale.
- Here's how we process it.
- Here's what's in it.
To learn more about this registration process and how it's VERY different from an FDA approval, see my video below:
So let's look at the website to see if the language there holds to these statements about making no claims of how these products work (outcomes).
"Clinical Results Show Effective Recovery without Surgery"
This is the statement that greets us. Hmmm...This is a claim of efficacy, so already we're outside of the above statement. This is also very broad and as a consumer, I would look at this as applying to me. Given that the number-one diagnosis for patients seeking stem cell therapy is knee arthritis, I would assume that this applies to the knee. Does it? That took some digging, and I'll get there, but first let's look at what else is here. Next, we see this: "BioRenew® PTM Therapy™ is used to successfully treat patients suffering from many injuries, arthritis, degenerative conditions and other ailments holding people from living a much more functional life." So here we see that the clinical results apply to many injuries, arthritis, degenerative conditions, and other ailments. Next, we see what seems to be outcome data, but what's not there is more important than what's there. Let me explain. First, we learn that 10 out of 11 arthritis patients had relief of their arthritis symptoms. That's odd? It would be customary to quote that there was a certain number who responded out of ten patients (i.e., a simpler way to report a percentage response rate). Turns out that it says 11 patients because that's all of the patient data being reported here. Meaning, we're only talking about 11 patients! Then we learn that "Results following one treatment with BioRenew® PTM Therapy™ for knee, shoulder, hip and wrist arthritis." Hmmm... So I guess we're talking about 11 patients who had either knee, shoulder, hip, or wrist arthritis? For comparison, I went to our Regenexx website to look at the number of treated patients for these categories for whom outcome data was available:
- Knee—5,527 patients
- Shoulder—968 patients
- Hip—1,234 patients
- Hand/Wrist—247 patients
- Total=7,976 patients
So this company is hanging its proverbial hat on 11 patients? There is more reported on the next page, so let's review that as well.
More Outcome Problems
Once I try to dig into the BioRenew® PTM Therapy™ outcome story it gets even more confusing for me as a practitioner and researcher. Here's what you find:
- The 10 of 11 patients that "reported relief" of what seems to be "arthritis symptoms" at 12 weeks. First, most studies looking at outcomes in arthritis require a minimum of 6 months to 12 months reporting after the therapy. Why? Lots of things give patients relief for a few months, fewer therapies last a year. This gets doubly true when you look at patients with severe arthritis. In addition, there is no detail on what "relief" means. Did the patients get 50% or greater relief? Was a functional or pain questionnaire used? Was it the patient or doctor who determined the relief? There are no such details.
- "Successful Treatment of Orthopedic Sports Injuries-In this published study, patients with acute or chronic tendon and muscle injuries received a single treatment of BioRenew® PTM Therapy™." This section says that patients had 60% relief at 1 week and 100% relief at 5 weeks. No information is listed on the number of patients. No information is provided on what diagnoses these patients had at the time of their treatment. None of the questions above are answered. I then searched the US Library of Medicine and found NO published data or research on BioRenew® PTM Therapy™.
- "Non-Surgical Treatment of Foot and Ankle Injuries-BioRenew® PTM Therapy™ was used to treat patients who had failed conventional treatment, and would have otherwise required surgery. 12 out of 17 patients recovered completely after just one treatment." This is the same as above. No publications were found, and we know nothing about these patients, what outcome metric was used, how the data was generated, etc...
So we seem to have three patient groups described, but scant information is provided about what was done, how it was done, why it was done, (in one case, how many patients were treated), or how the results were measured.
Is BioRenew® PTM Therapy™ Really Registered to Treat Orthopedic Injuries?
The website says, "BioRenew® PTM Therapy™ is the only PTM (Placental Tissue Matrix) Therapy registered with the FDA intended to treat the tissues of tendon, ligament, cartilage and bone injuries." Hmmm... I know the FDA process for 361-registered tissues, and as far as I understand, there is no way to register a medical indication, but let's check. This product is made by Skye Biologics. Going to the FDA website, I see that they have two 361 HCT/P forms listed. One is inactive and it was to store or label a bone product. The other is active and it is to store and distribute amniotic membrane and placenta. The first thing I learned is that Skye is not a manufacturer based on its FDA form. The second thing is that there is no place on this form to list that there is an orthopedic indication for these tissues. In fact, as I remembered correctly, that's not even part of the form/process.
Is BioRenew® PTM Therapy™ a Stem Cell Therapy?
If you want to be really confused, try to find out based on Google searches if BioRenew® PTM Therapy™ is a stem cell therapy. First, the phrase stem cell is used three times on the main website page. Next, on a Google search, we see this guy:
He says he's a doctor (I think he's a chiropractor, but I can't confirm as his website doesn't say). He says that BioRenew® PTM Therapy™ is FDA approved (you now know that's not true as, instead, all it has is a 45-minute quickie tissue registration). He repeats the claim that there is a medical indication (see above), and he clearly states, "BioRenew Therapy has an ironclad patented process of keeping those stem cells preserved and viable for as long as possible." So he claims that this is a stem cell therapy. I also found claims by Neomatrix Medical (an acupuncture/alternative health clinic) that BioRenew PTM is a stem cell therapy. In fact, their website says "Are you ready for the next generation in stem cell therapy?" Their video says, "...so we can conclude that the ideal source of stem cells has to contain: stem cells, bio-molecules, growth factors, and collagen scaffold and the only two human tissues that contain all of those essential components are umbilical cord and placental tissue." (This is actually not a true statement as bone marrow has all of these with its scaffold being nature's finest—the marrow clot.) They will also send you a 33-page report! It wasn't hard to find their 33-page report online. Its title is "BioRenew® PTM Therapy™." The report contains numerous statements that aren't true, but we'll leave that for another day. However, here's the shocker from the report: "The placenta contains approximately 100 million AEC's (amniotic epithelial cells) which have all the properties of stem cells. However, these cells are no longer viable (or alive) after the procurement, processing and manufacturing. In other words, there are NO live cells in our PTM or Placenta Tissue Matrix." Hmmm... We have two alternative-health practitioners claiming in some places that BioRenew® PTM Therapy™ is a stem cell therapy. One is claiming that the company uses a patented process to preserve stem cells and the other has a website claiming that it is a stem cell therapy and video discussing that placental tissue matrix has stem cells. However, then there is this 33-page report that clearly states there are no stem cells. I'm so confused...
The upshot? The data reported by the BioRenew® PTM Therapy™ website purporting to show that this stuff works is skeletal at best. Meaning there are many more questions than answers about its efficacy. Even more confusing is whether this is a stem cell therapy. For the average consumer, it would be easy to believe that this product contains stem cells. However, digging deeper shows that it does not contain stem cells? Buyer beware, folks...
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