New Disc Treatment: DISCSEEL™ to Heal?
POSTED ON 6/2/2016 IN Archive BY Christopher Centeno
For patients with chronic low back pain, there are more non-surgical options than ever in 2016. This can also be a two edged sword, in that there's also more misinformation. This morning I'd like to highlight a new disc treatment called Discseel™ (aka Diskseel ™) that's seems to have lots of confusion surrounding it and analyze what's real and not.
This story begins many years ago when a local orthopedic sales rep came to our office and told us about a new disc therapy using fibrin sealant to help disc pain. The idea was that you could inject this stuff into a disc and seal the holes and that would help the patient. Fast forward a decade and a half, and now a similar technology (Discseel™ aka Diskseel ™) has appeared on the Internet, now claiming high-level research to support that it's effective as a treatment for degenerative discs. So is sealing the disc helpful? Or is the research that's being used to promote it deceptive?
What Is Fibrin Sealant?
Fibrin is what gives blood clots their mojo. It's a mesh of fibers that can be laid down on demand via a protein that lives in blood called fibrinogen. In that form, it's soluble, so it's dissolved in blood and can course through the circulatory system. However, through the intricate dance of natural factors and chemicals involved in blood clotting, it can be converted to fibrin strands to form a blood clot.
The same fibrin that causes a clot can be isolated and injected and then activated to form a rubber-cement-like substance that the body will dismantle and dissolve over time. This is often called "fibrin glue" (or also "fibrin sealant") and is used most often these days in the ER and during surgery to help close wounds.
The Disc Fibrin Sealant Story
A decade after the sales reps first visited me with his new disc treatment, I began to hear about physicians using this technology and showing X-rays of "plumped up" degenerated discs at spine conferences. The idea was that degenerated discs can't heal because they have tears and holes and that by sealing the discs through an injection of fibrin sealant, the disc could be made to heal and would regain its lost height.
Given that these were n=1 one-hit wonders, I kept tabs on the technology and heard that it was undergoing an FDA trial via a company called Spinal Restoration, Inc. in Austin, Texas. I thought this was good news, in that maybe one day, if the procedure worked well, other physicians would get to use the system.
I didn't hear anything about the technology for many years, until 2013 when our CEO at the time got a couple panicked calls from employees he knew who worked for the company. The gist was that their disc sealant product had flubbed its FDA trial by failing to show that these injections were better than saline, so the company was being closed. I figured that was the last I would hear of the company's mantra, "To seal is to heal." However, I was wrong. Last year the new disc treatment technology resurfaced, now being used by a Texas medical practice and claiming to have loads of research supporting that it was effective. Huh?
Fibrin Disc Sealant Rises from the Ashes
The interventional spine community is still relatively small, so I made some calls and confirmed with the lead study author the negative FDA trial results he had presented at a national conference. In summary, the disc sealant treatment didn't work better than saline injected into a disc. Huh? How does that jive with a new company claiming it works well?
Despite this news, the new company pushing the "new disc treatment" was not only advertising that it worked and had research to support its effectiveness, but was also teaching the technique nationally through a series of conferences. Hence, I decided it was high time to take a few hours and delve into what is published and is not published on this technique. Maybe the physicians behind Discseel™ (aka Diskseel) had performed and published new research I didn't know about? Here's what I found listed in the US National Library of Medicine:
- A pig model of degenerative discs showed that injecting fibrin sealant helped pig discs heal. The big issue here is that pretty much anything injected into pig discs, from platelet rich plasma (PRP) to stem cells to chondrocytes, help pig discs heal, so the real challenge would be helping human discs, which are very different structurally.
- A small pilot study that was published as part of the FDA approval process that showed promising results in 15 patients. On the positive side, the procedure seemed to reduce pain and increase function in patients with painful degenerative disc disease. On the other hand, there was one case of discitis in just 15 patients, which was a bit concerning. Near as I can tell, this means that there was a disc infection, which should be more like one in several hundred to one thousand patients, but maybe it's possible that the authors were just unlucky? Maybe this was just a local response to the fibrin? The paper doesn't say.
- The phase-III FDA approval trial consisted of 220 patients with painful degenerative disc disease. Patients were randomized to get either the fibrin sealant injection into their painful disc or a placebo (which was an injection of saline). At the end of six months, there was no statistical difference in pain or function between the disc sealant and the saline injection.
That's it! There is nothing else that I can find listed in the US National Library of Medicine on this topic.
DISKSEEL™—New Disc Treatment or Revising History
The fibrin disc sealant procedure has now been renamed Pauza Discseel™ (from BIOSTAT BIOLOGIX), and the new company now states that there is good research supporting its therapy.
This is from their website: "The North American Spine Society Outstanding Study of the Year was awarded to FDA research confirming the Biologic used in Pauza Discseel™ regrows..."
Where did that come from? The pig study above when it was presented at a spine meeting
. So "regrows" must refer to pig discs, not their human counterparts...What else is on the new website?
"FDA INVESTIGATION CONFIRMED THAT FIBRIN BIOLOGIC INJECTED INTO A SPINAL DISC IMMEDIATELY SEALED THE DISC.
With normal Saline, the viscosity of Stem Cells immediately leaked out of the disc, if the disc was not first sealed with Fibrin Disc Sealant.
More specifically, 91% of the discs were immediately sealed, resisted pressure of 100 lbs/sq inch. Additionally, this FDA data demonstrated only 11% of the discs injected with normal saline (Stem Cell viscosity) didn't leak immediately."
The actual pre-PMA study was only performed to see if fibrin could seal a disc, which it did (not on stem cells as inferred). However, none of this speaks to whether fibrin injections in a live human disc will help patients (which the FDA-approval study shows it did not).
"Kevin Pauza, MD, developed a Spine procedure Pauza Discseel™ utilizing a natural, injectable Biologic, thus revolutionizing spine treatment. This Biologic, injected into discs during Pauza Discseel™, proves more safe than spine fusion surgery. No spine fusion treatment has ever been more rigorously studied, as the Biologic utilized in Pauza Discseel™, in a randomized, placebo controlled fashion. A respected Johns Hopkins' study confirmed a stem cell treatment caused cancer, and stem cells obviously leak, unlike fibrin utilized in Pauza Discseel™."
As you can see from above, a randomized, placebo controlled trial was performed, but it showed the procedure didn't work
(which is curiously absent from this statement). I have no idea which Johns Hopkins study this statement refers to, as no reference is given. We just published the world's largest safety study in stem cells
covering 2,373 patients followed for up to 9 years (including discs treated with stem cells) and found no evidence
that stem cells caused cancer. I'm not a name dropper, but one of the co-authors on our paper is from the Mayo clinic and another on an earlier safety paper is from Harvard!
The rest of the website goes on to repeat more of the same, referencing only the nine patient pilot study above, but nothing is written about the negative trial result.
So Does Sealing the Disc Work?
So what evidence is there? All we have that suggests that sealing the disc could work is a 15-patient study that was refuted by a 220-patient study that couldn't beat a placebo injection. It's my understanding that the founder has now altered the technique to improve it (hence the new name), but there's no research published on that new technique.
I really can't comment on whether the new version works until there is some published research. In the meantime, treating painful discs with autologous biologics has better research behind it in 2016 than sealing discs with fibrin. There is one small case series suggesting that same-day bone marrow stem cells injected into discs help pain and improve function and one small randomized controlled trial showing that PRP helps. Hence, I'm not sure our clinic would have a pressing reason to inject fibrin sealant into a disc.
The upshot? This history of fibrin disc sealant is a fascinating story. Is this treatment effective? I would say that the balance of the data argues against it at this point. One concern is that like many websites in this arena, superficially, it looks like there is solid data supporting Discseel™ (aka Diskseel ™). However, also like many other websites, digging a bit deeper shows that there is little evidence in 2016 that supports that this is the right approach for patients with a painful degenerative disc. That certainly doesn't preclude offering the therapy, in my opinion, as it's probably safe and perhaps there's a subset of patients who could respond well. However, the average patient researching the technology will clearly be confused about the research.
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