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Treatments

The Discseel® Regenerative Spine Procedure

A therapy that injects an FDA approved biologic into the intervertebral discs.
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What is The Discseel® procedure?

Traditional treatments for repairing a damaged or torn spinal disc leave patients with a host of side effects, and don’t consistently provide relief.  Discseel®  is a revolutionary procedure using an FDA approved biologic to repair your damaged spinal disc.

It is a minimally invasive procedure that injects an FDA approved biologic into intervertebral discs. This is able to repair and seal damaged spinal discs, where spine surgery, including spinal fusions, can’t.

How Discseel® Works

Your intervertebral discs are oval structures that work as cushions between your spine bones (vertebrae). These discs are made of two regions: the inner jelly-like region (Nucleaus pulposes) and the outer harder rim (Annulus Fibrosis).

Due to age, disease or trauma, the outer rim of intervertebral discs undergoes wear and tear. The outer rim, (Annulus Fibrosus) can tear leading to leaking of the soft center out into the intervertebral canal. This frequently leads to problems like nerve irritation and back pain. Sometimes the tears are microscopic while other times they can be obvious.

See How Discseel® Works:

The FDA approved biologic used  aims at healing these tears. When injected into the targeted discs, the FDA approved biologic  works in two main ways. The immediate effect includes filling up the tears in the discs. The long-term benefit is that it adds to the strength and stability of the intervertebral discs.

What Conditions can be Treated With Discseel®?

While the research is still ongoing, The Discseel® Procedure can help with back pain due to:

Is There Any Research Evidence to Support Discseel® Therapy?

A 2020 study of 320 patients that is pending publication reports that: “Statistically significant improvement was realized in every outcome tool comparing baseline to; 3-months, 6-months, and 1-year post-treatment. No subject was lost to follow-up or withdrawn, and no subject experienced an adverse event. The results of the longitudinal analysis demonstrated statistically significant improvement in all outcomes measured.” See below for details.
discseel-therapy
2024 Abstract Pending Publication
Evaluating the safety and efficacy of fabrin to treat multi-level chronic discogenic low back pain.
Discogenic chronic low back pain (cLBP) and radiculopathy are the most prevalent causes of disability worldwide. Older spine treatments often lack reliability and are associated with adverse events. Among surgical treatment options, discectomies weaken discs, and fusions cause direct damage to adjacent discs, so both treatments accelerate disc degeneration. Other regenerative medicine treatments, including “stem cell” (centrifuged bone marrow aspirate, BMC), and platelet-rich plasma (PRP), lack fibrin’s bio-adhesive properties. Specifically, fibrin is a strong bio-adhesive, so it immediately integrates into disc defects and binds there, becoming a part of the disc and facilitating new disc tissue growth.
To evaluate the safety and efficacy of this new pragmatic algorithm that both diagnoses and treats cLBP by (i) first identifying annulus fibrosus tears (fissures) in the region of symptoms and (ii) subsequently treating those tears by introducing fibrin to seal them and facilitate new tissue growth.
Retrospective cohort study that prospectively reported validated measures in a registry.
Private, single-center, specialized, interventional pain management institution.
The patients we decided to observe had suffered from cLBP with or without radiculopathy symptoms in their legs for greater than 6 months. Prior to enrollment, all patients underwent physical therapy and at least 4 invasive treatments without relief. Failed treatments included BMC or PRP injections, intradiscal or intraarticular zygapophyseal joints, or combinations of both. Fluoroscopically guided epidural injections of corticosteroids or PRP were additional failed treatments, as were radiofrequency neurotomies in the medial branch. Candidacy for enrollment was based on meeting the aforementioned criteria and by having magnetic resonance image (MRI) screenings (1.5 T) and plain-film radiographs performed 6 months before treatment. In addition, those MRI screenings and radiographs had to rule out the following concomitant conditions: (i) carcinoma, (ii) fracture, (iii) instability, or (iv) severe vertebral canal or intervertebral foramen stenosis.
Significant improvement was demonstrated at one, 2, and 3 years after treatment in all outcome measures. The mean duration of low back pain prior to treatment was 11.2 years. Patients’ mean age was 56 years. Thirty percent of the patients were female, and 70% were male. Both the failed surgery cohort and nonsurgery cohort demonstrated significant improvement after fibrin treatment, with the failed surgery cohort realizing greater relative improvement. Significant improvements in the Oswestry disability index (ODI), visual analog scale, and PROMIS® (mental and physical) scores were consistent across age, gender, comorbidity, and exposure status. At the 12-month follow-up, 50% of patients achieved minimal clinically important differences utilizing the ODI. No severe adverse events were reported.
Limitations include patient demographic factors, outcome-measure sensitivity, and that the outcomes were reported prospectively and calculated retrospectively as one-, 2-, and 3-year time frames were attained. Although categorical analyses comparing the prior surgical cohort to the nonsurgical cohort were performed, other pre-enrollment treatments were not categorized for comparison.
Intra-annular fibrin bio-adhesive sealant demonstrates the ability to be an effective treatment for alleviating discogenic cLBP and radiculopathy for at least 3 years, even in patients who all failed multiple prior treatments, including discectomy, fusion, disc PRP, or BMC. The results suggest the benefits of fibrin sealant. Future investigations to consider include a randomized double-blind controlled trial and further categorical analyses.
Low back, radiculopathy, fibrin, disc herniation, degenerative disc, regenerative, annulargram, annulogram

The Four Steps of The Discseel® Procedure:

1

Consultation

We begin by a phone consultation followed by a consultation by our Medical Director, Janet D Pearl, MD MSc. We ask you to send us your CT or MRI scan ahead of time so we can do a preliminary evaluation. Then, if we think you are a suitable candidate, we’ll have you come in for a in-person consultation to meet with our Medical Director, Janet D Pearl MD MSc who will perform the Discseel® Procedure. We want to answer all your questions prior to the procedure.

2

Annulogram

The annulogram is a pain free fluoroscopic X-Ray examination of your discs. We inject a small amount of X-Ray contrast into the outer rim of your intervertebral discs. This determines if your discs are leaking. We can identify very small subtle disc tears (even before they cause herniation or degeneration.) Anything missed by an MRI or CT will show up in the annulogram.

3

Discseel® Procedure

Immediately after the annulogram, we inject an FDA approved biologic into each damaged disc, which seals the leaks. The entire procedure is done live under x-ray guidance.

4

Recovery

After the procedure most patients are up and walking within 24 hours. Immediately after the procedure, your damaged discs will start healing, which is a continuous process over the next 12 months. Most patients experience relief at 3-6 months post procedure because our discs heal slowly.

FAQs

Frequently Asked Questions

Is there any research based evidence to support Discseel® therapy?

A 2020 study of 320 patients that is pending publication reports that: “Statistically significant improvement was realized in every outcome tool comparing baseline to; 3-months, 6-months, and 1-year post-treatment. No subject was lost to follow-up or withdrawn, and no subject experienced an adverse event. The results of the longitudinal analysis demonstrated statistically significant improvement in all outcomes measured.”

 
 
 
What’s the process to get treated with The Discseel® Procedure?
  1. Consultation. We begin by a phone consultation followed by a consultation by our Medical Director, Janet D Pearl, MD MSc. We ask you to send us your CT or MRI scan ahead of time so we can do a preliminary evaluation. Then, if we think you are a suitable candidate, we’ll have you come in for a in-person consultation to meet with our Medical Director, Janet D Pearl MD MSc who will perform the Discseel® Procedure. We want to answer all your questions prior to the procedure.
  2. Annulogram. The annulogram is a pain free fluoroscopic X-Ray examination of your discs. We inject a small amount of X-Ray contrast into the outer rim of your intervertebral discs. This determines if your discs are leaking. We can identify very small subtle disc tears (even before they cause herniation or degeneration.) Anything missed by an MRI or CT will show up in the annulogram.
  3. Discseel® Procedure. Immediately after the annulogram, we inject an FDA approved biologic into each damaged disc, which seals the leaks.  The entire procedure is done live under x-ray guidance.
  4. Recovery. After the procedure most patients are up and walking within 24 hours. Immediately after the procedure, your damaged discs will start healing, which is a continuous process over the next 12 months. Most patients experience relief at 3-6 months post procedure because our discs heal slowly.
 
 
Am I a candidate for The Discseel® Procedure?

Any person with long lasting low back pain is a potential candidate. A person with low back pain who’s had surgery or a person with low back pain who prefers to avoid surgery is also a potential candidate, because the cushion in the back known as the disc is the most common cause of low back pain. Contact us to find out if you are a candidate.

 
Is it painful?

No. We use conscious sedation during the procedure, so it is not painful or uncomfortable for our patients. Conscious sedation is a combination of medicines to help you relax (a sedative) and to block pain (an anesthetic) during a medical procedure. Under conscious sedation, you may fall asleep, but you will wake up easily to respond to people in the room. You may be able to respond to verbal instructions. After conscious sedation, you may feel drowsy and not remember much about your procedure, but you will recover quickly and we encourage you to begin walking the next day.

 
What is the recovery time?

This is an outpatient procedure done in a morning or afternoon. You will likely need a few days to rest, however, we want you up and walking around the day following your procedure. After the first few days, when you are feeling up to it, we want you to begin a daily regimen of walking, gradually building up your walking distance every few weeks. Most people need prescription pain medication for the first few weeks.

Most people see a change within 3 – 6 months after the Discseel® procedure, and some are sooner than that. Most people are back at work the week after their procedure. It is normal to experience increased symptoms after your procedure and then go through a period of time where the pain waxes and wanes for several months.

The main thing to remember following your procedure is to avoid two movements: flexion (forward bending) and rotation (twisting). Flexion is a compressive force and rotation is a shear force, both of which can damage and tear discs. Many people ask, “How long do I have to avoid those movements?” We encourage all patients to avoid these movements as a lifestyle because we know these are the two forces that can damage and tear discs. We recommend working with a physical therapist for a short period of time following the procedure to learn new body mechanics in order to avoid movements that cause wear and tear on the discs.

 
How long will it take for my disc to be healed?

It can take 3 – 12 months for the disc to be restored and for you to have noticeably decreased pain and improved function. Beginning the day of your procedure, your discs will begin the healing process. Most patients experience increased symptoms following the procedure for several weeks and do not notice significant change from their usual pain for 3-6 months. Occasionally some notice a quick difference, but that is the exception, not the norm.

 
What about my current pain medications?

We will work with your prescriptions and provide pain medications immediately following your procedure. If you are an out of state patient, because of pharmacy regulations, we ask that you follow up with a pain management doctor in your hometown before your prescription runs out if you need to continue medications to manage your pain.

 
I read online that Discseel® doesn’t work.
Early Fibrin disc treatments were initially performed over 14 years ago to establish patient safety and demonstrate Fibrin’s ability to allow patients to avoid spine surgery. We have substantially refined the process since then:
  1. Annulograms. We use diagnostic Annulograms, which are more sensitive and precise than previously utilized discograms or MRIs. Early studies relied on simple MRIs and discograms to identify disc tears needing repair. However, recent studies show that these lack the sensitivity to identify all annular tears. Annulograms are far more precise and accurate in identifying tears.
  2. Annulus Fibrosis Targeting and Treatment.
    1. As we do the Annulogram to identify the annular tear, we keep the needle in place in the annular tear and immediately inject the FDA Approved biologic. This allows the precise targeting into the tear to repair the source of pain. Research demonstrates that disc pain occurs within tears of the annulus fibrosus so we now target the repair directly to the painful annular tears.
    2. Avoiding disc disturbances. We intentionally targeted the biologic away from the disc’s central nucleus pulposus gel. Introducing anything to the center of the disc can worsens matters by displacing the gel outwards. If the central gel (the nucleus pulposus) leaks right through the disc, it can cause inflammation of the spinal nerve roots resulting in more pain.
    3. Sealing the tears restores disc strength. Research affirms that the biologic mechanically seals annular tears, restoring disc strength to normal. Strength is maintained as  the biologic is naturally replaced, molecule per molecule, with normal disc tissue (collagen Type I and II) over the months following the Discseel® Procedure. Furthermore, by sealing the tears, we can use PRP and other regenerative biologics, since they won’t leak. (Without the biologic to seal the tears, PRP and other regenerative biologics quickly leak from discs.)
  3. Antibiotics. During the Annulogram, we inject antibiotics into each disc. Since this refinement, no patient has ever experienced an infection or blood-borne pathogen of any type.
  4. Multiple Disc Treatment. We now treat more than three discs in almost every patient. The early study limited treatment to two discs in effort to make the procedure simple for spine physicians. This compromised the treatment since almost all patients suffer from at least three torn discs so treatment should not be limited to 2 discs.

References

Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up. Yin W, Pauza K, Olan WJ, Doerzbacher JF, Thorne KJ.; Pain Med. 2014 Jan;15(1):16-31. doi: 10.1111/pme.12249. Epub 2013 Oct 23. Link to article

 

Discseel® Regenerative Spine Procedure Website. Link to website

 

Treatment of annular disc tears and “leaky disc syndrome” with fibrin sealant. Pauza K MD, Wright C BS, Fairbourn A Best, Mark.;  Techniques in Regional Anesthesia and Pain Management Vol 19, Iss 1–2, Jan–Apr 2015: 45-49. Link to article

 

Intradiscal Biologic Treatments: Intra-annular Fibrin Disc Sealant. Kevin Pauza MD; Advanced Procedures for Pain Management: A Step by Step Atlas; Ed: Diwan S , Deer TR, 1st Ed, 2018 Edition pp 525-536.

 

Fibrin Injection Stimulates Early Disc Healing in the Porcine Model. Buser Z, Kuelling F, Jane L, Liebenberg E, Tang J, Thorne K, Coughlin D, Lotz J; The Spine Journal 9(10) · October 2009 Link to Article

 

Spinal Fusion for Chronic Low Back Pain: A ‘Magic Bullet’ or Wishful Thinking? Dhillon KS.; Malays Orthop J. 2016 Mar; 10(1): 61–68.