New Disc Treatment: DISCSEEL™ to Heal?

By Chris Centeno, MD /

Receive a Regenexx® Patient Info Packet by email and learn why it's a superior regenerative solution.

New Disc Treatment

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.

Leave a Reply

Your email address will not be published. Required fields are marked *

19 thoughts on “New Disc Treatment: DISCSEEL™ to Heal?

  1. Robin

    So timely that you write about this as I was reviewing this doctor, the treatment and his website yesterday and was about inquire as to your thoughts on this treatment.

    1. Regenexx Team Post author

      Robin,
      That’s quite the coincidence!

  2. stef

    Many researchers working on stem cells use some sort of gel. It helps keep the stem cells where you want them while providing nutrients. Your thoughts on gel technology ?

  3. Chris Centeno Post author

    Stef, yes a hydrogel can be helpful, but stem cells are very good at attaching to things, so while using a gel helps get them in a 3D matrix, it reduces the ability of the cells to attach to the disc tissue itself.

  4. Regenexx Team Post author

    This topic has been debated back and forth on a Linkedin professional group dedicated to biologic orthopedic treatments. We invite you to continue the conversation there: https://www.linkedin.com/groups/4464752

  5. Merle Kaufman

    This is one of the few comments I could find about this procedure that didn’t come from Dr. Pauza’s own website. The other was a discussion in Spine Health generated y a woman whose 19 yo son was hospitalized with severe pain from an infection after this procedure, followed by multiple complications. My physiatrist recommended this as a possible way to create height in a disc, and avoid another spine surgery. Thinking of flying to Texas from NYC had given me pause, as well as not being able to find independent mention of this tx anywhere since a CBS report in 2012.

  6. Glenn

    I do know Pauza treated the king of Saudi Arabia and was given a 250000$ car in appreciation by said King

  7. Mary

    My neuro surgeon has suggested this procedure for me after a discogram.He is a George Washington Hospital professor.
    He told me that Baxter was the company that makes fibrin.
    Any updates or studies that you might refer me to?

    1. Regenexx Team Post author

      Mary,

      Yes, please see: https://regenexx.com/blog/avoid-discography-side-effects/

  8. Denis McCarthy

    Many don’t realize a herniated disc means the end of your life…If I have to be fused just hope you die during the surgery.When you 1st approach your Chiropractor and he says you may have a herniated disc.. Your life definitely changes for the worst. That’s when you slowly decend to death.U’ll want to die after they fuse you.They say discs reherniate at a 5% rate after Microdisectomy. Read Spine Health it’s happened to basically everyone. You live your life thinking a herniated disc is nothing. It will change your life forever. It will eventually lead to fusion. Then you will wish you died.Don’t let any doctor talk you into Spinal Fusion. It’s all about money and you’ll be miserable for the rest of your life.. They make it sound so simple in the videos with smiling patients and nurses.. You will wish you died . I’ll be using Dr Pauzas procedure

    1. Regenexx Team Post author

      Denis,
      Thankfully, a herniated disc can often be treated using your own plateles and or stem cells. Very importantly, more than the disc needs to be treated. https://regenexx.com/blog/stem-cell-disc-treatment/ https://regenexx.com/blog/should-you-get-your-disc-injected-with-stem-cells/ https://regenexx.com/blog/avoid-discography-side-effects/ To see if your particular issue would be a Candidate please submit the Candidate form, or call 866 684 9919. If not, hope we your results defy the research and you get a great outcome!

  9. Erica M.

    So I have noticed that this article reads more as an option of the procedure and like an attack then an article of substance. I want to make sure there is a balanced opinion. I received the procedure at his office in Tyler back in 2012. Prior to the get it done I was in constant pain for years. It got so back I had to give up running in marathons hell even just running for fun. After the procedure I was able to enjoy spending time with my husband running again, here in our home in Maine.

    The reality is simple it has been just over six years, I have not had to take pain pills or get a follow up procedure since. So you can say what you feel about the procedure, or that you don’t feel it works. But can I suggest that you talk to the patients that have benefited from it before you just right it off.

    1. Chris Centeno Post author

      Erica, the procedure may work just fine in select patients. The question is whether a simple one thousand dollar PRP shot may work just as well. Meaning, for you, you had X procedure performed and it worked, that’s all you need to know. However, my job as a doctor is to look at multiple procedures that might work and apply the least invasive, least expensive one that is the most likely to help. Right now we have better data that PRP will help than we do on DiscSeel (which has one trial showing it’s ineffective in most patients).

  10. Robin Summers

    My husband had it done 6 years ago. Went back because Kevin Pauza could not get enough in. Through second time my husband woke up during the procedure. My husband was yelling for them to stop. The doctor said it didn’t hurt and instructed his assistance to hold my husband down to finish because he was in hurry. My husband was supposed to be out of there in a few hours I don’t know how many hours it was before they are actually brought him out. Just disgusting. Reduced pain some for about 3 months. Had to pay cash. The last of our savings. A total waste and nightmare.

  11. R.Norris, MD

    My patient went to NYC to have this done after a micro disectomy failed to relieve his pain. He was charged $14,000 ( which of course was not covered by insurance). He is still having pain. They “sealed” the L3 in the L4 disc as well even though they were completely normal on MRI with no evidence of annular tears or protrusion. He was told they were leaking as well. He was told no extra charge for those, it would’ve been $14,000 whether they did one disc or three discs. Whether or not this treatment is benig, people should still be aware that it is enormously expensive and unproven.

  12. Margaret Brown

    Was the above info written in 2016? If so, is there any update on results for patients (not on Discseel’s advertising website)? Or any improvement in results, in general. Still sounds too good to be true.

    1. Chris Centeno, MD Post author

      No real updates that I know of on DiscSeel. We use a same day stem cell procedure in these patients and they generally do well.

  13. Michael

    Is there any real data for the Discseel Procedure
    So I have been looking at getting the Discseel Procedure for my back but I am concerned about the data. Basically none of the studies on doctor Kevin Pauza’s website or the Discseel website link to actual studies. So I started googling them and talked to my doctor about the studies I found.

    What I found was most of the studies don’t say much and only two of the studies are even about the fibrin injections. So I am hoping I can find out if any one out their has seen any actual data or study. $16,000 seems like a lot of money to spend out of pocket on a procedure that has no relevant studies. Has anyone found or seen a recent reputable study on this procedure. All I can find is testimonials videos, and the claims they make on their websites.

    The other concern I have is the lead Dr. Kevin Pauza appears to have gotten in trouble multiple times the medical board. Should I be concerned about this? Does anyone have any advice?

Chris Centeno, MD

Regenexx Founder

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications.
View Profile

Get Blog Updates by Email

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Regenerative procedures are commonly used to treat musculoskelatal trauma, overuse injuries, and degenerative issues, including failed surgeries.
Select Your Problem Area
Shoulder

Shoulder

Many Shoulder and Rotator Cuff injuries are good candidates for regenerative treatments. Before considering shoulder arthroscopy or shoulder replacement, consider an evaluation of your condition with a regenerative treatment specialist.

  • Rotator Cuff Tears and Tendinitis
  • Shoulder Instability
  • SLAP Tear / Labral Tears
  • Shoulder Arthritis
  • Other Degenerative Conditions & Overuse Injuries
Learn More
Cervical Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Knee

Knees

Knees are the target of many common sports injuries. Sadly, they are also the target of a number of surgeries that research has frequently shown to be ineffective or minimally effective. Knee arthritis can also be a common cause for aging athletes to abandon the sports and activities they love. Regenerative procedures can be used to treat a wide range of knee injuries and conditions. They can even be used to reduce pain and delay knee replacement for more severe arthritis.

  • Knee Meniscus Tears
  • Knee ACL Tears
  • Knee Instability
  • Knee Osteoarthritis
  • Other Knee Ligaments / Tendons & Overuse Injuries
  • And more
Learn More
Lower Spine

Spine

Many spine injuries and degenerative conditions are good candidates for regenerative treatments and there are a number of studies showing promising results in treating a wide range of spine problems. Spine surgery should be a last resort for anyone, due to the cascade of negative effects it can have on the areas surrounding the surgery. And epidural steroid injections are problematic due to their long-term negative impact on bone density.

  • Herniated, Bulging, Protruding Discs
  • Degenerative Disc Disease
  • SI Joint Syndrome
  • Sciatica
  • Pinched Nerves and General Back Pain
  • And more
Learn More
Hand & Wrist

Hand & Wrist

Hand and wrist injuries and arthritis, carpal tunnel syndrome, and conditions relating to overuse of the thumb, are good candidates for regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Hand and Wrist Arthritis
  • Carpal Tunnel Syndrome
  • Trigger Finger
  • Thumb Arthritis (Basal Joint, CMC, Gamer’s Thumb, Texting Thumb)
  • Other conditions that cause pain
Learn More
Elbow

Elbow

Most injuries of the elbow’s tendons and ligaments, as well as arthritis, can be treated non-surgically with regenerative procedures.

  • Golfer’s elbow & Tennis elbow
  • Arthritis
  • Ulnar collateral ligament wear (common in baseball pitchers)
  • And more
Learn More
Hip

Hip

Hip injuries and degenerative conditions become more common with age. Do to the nature of the joint, it’s not quite as easy to injure as a knee, but it can take a beating and pain often develops over time. Whether a hip condition is acute or degenerative, regenerative procedures can help reduce pain and may help heal injured tissue, without the complications of invasive surgical hip procedures.

  • Labral Tear
  • Hip Arthritis
  • Hip Bursitis
  • Hip Sprain, Tendonitis or Inflammation
  • Hip Instability
Learn More
Foot & Ankle

Foot & Ankle

Foot and ankle injuries are common in athletes. These injuries can often benefit from non-surgical regenerative treatments. Before considering surgery, consider an evaluation of your condition with a regenerative treatment specialist.
  • Ankle Arthritis
  • Plantar fasciitis
  • Ligament sprains or tears
  • Other conditions that cause pain
Learn More

Is Regenexx Right For You?

Request a free Regenexx Info Packet

REGENEXX WEBINARS

Learn about the #1 Stem Cell & Platelet Procedures for treating arthritis, common joint injuries & spine pain.

Join a Webinar

RECEIVE BLOG ARTICLES BY EMAIL

Get fresh updates and insights from Regenexx delivered straight to your inbox.

Subscribe to the Blog

FOLLOW US

Copyright © Regenexx 2019. All rights reserved. | Privacy Policy

*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.