Early Fibrin Study vs New

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Discseel® Procedure Refinements 

This information provides Physicians an in-depth understanding of the Discseel® Procedure refinements, differentiating it from the early foundational work that provided its strong foundation. This also shares the benefits of Discseel® Procedure over the basic stem cell treatments. Our Physician training program for the Discseel® Procedure is highly competitive, and so currently there are several hundred Physician Applicants for each position available. 

This document details important refinements of the Discseel® Procedure, and dispels misunderstandings conveyed by a Colorado stem cell franchise and others unfamiliar with important refinements which improve the Discseel® Procedure’s efficacy. The 570+ “general stem cell franchises” offer nothing unique to allow any to stand out, and so some rely on their rhetoric in an effort to capture patients preferring to undergo the Discseel® Procedure at specialty spine centers, instead of common stem cell treatments offered at non-specialty offices.

These following important refinements combine to improve the Discseel® Procedure’s efficacy and also attributes unique to the Discseel® Procedure. This procedure:

  1. Repairs tears in leaking discs
  2. Allows Fibrin to be replaced with normal disc tissue during the healing months following the Procedure
  3. Restores the disc’s normal mechanical and biochemical properties
  4. One especially unique attribute….only Discseel® works in combination with other regenerative medicine options, such as stem cells or PRP, by sealing them into leaky discs. This is an important attribute if one believes that stem cells have value to heal discs if they remain in those discs instead of leaking out of those discs, which many studies demonstrate. Benefits of the Discseel® Procedure keep other biologics inside the discs.

       

Discseel® Procedure Refinements vs Early Fibrin/Disc Studies

 

  1. Early Fibrin/disc treatments were initially performed over 14 years ago and established patient safety and demonstrated Fibrin’s ability to allow patients to avoid spine surgery. This early work forms a strong foundation for Fibrin.

  2. The first refinement of the Discseel® Procedure is the use of diagnostic Annulograms, which are more sensitive and precise than previously utilized discograms or MRIs. Early studies evaluating Fibrin/disc treatments relied on the “lesser” MRIs and discograms to identify disc tears needing repair. However, recent studies revealed that diagnostic discograms and MRIs lack sensitivity and so are not adequate to identify all annular tears needing repair. Therefore, to address those diagnostic weaknesses, the refined Discseel® Procedure utilizes the more sensitive and precise Annulograms instead of discograms and MRIs. Annulograms inject a trace amount of antibiotic with the radiopaque contrast.  

  3. The second refinement is that the Annulogram, which is performed during the Discseel® Procedure, allows the introduction of antibiotics into each disc, and since this refinement, no patient ever experienced an infection or blood-borne pathogen of any type.

  4. The third refinement is that the Annulogram needle identifies the annular tear, and then remains precisely in the annular tear, allowing the precise targeting of Fibrin into the tear to repair the annular defect. This is a logical refinement non-existent in stem cell treatments, and so not benefiting those stem cell disc treatments.

  5. The fourth refinement is that more than three discs are treated in almost every patient undergoing the Discseel® Procedure. This contrasts with most disc regenerative medicine studies, and the early placebo controlled Fibrin study, which limited treatment to two discs. Many aspects of that placebo controlled study continue to elude uninformed “stem cell marketers” including the Colorado “marketer.” Among all other refinements being denied in that study, the study’s supporters also limited treatment to two discs in effort to make the procedure simple for “average” spine physicians. Dr. Pauza proved those compromises limited the procedure’s efficacy, an so included all in the refined Discseel Procedure. Common sense dictates that because almost all patients suffer from more than three torn discs, and so therefore treatment should not be limited to 1-2 discs. Annulograms taught us that most people suffering with chronic low back pain have more than three torn discs. (Publications report over 95% of people suffering with chronic low back pain have more than 3 torn discs.)

  6. The fifth refinement is that all Fibrin is intentionally injected into the disc’s annulus fibrosus. Research demonstrates that disc pain occurs within tears of the annulus fibrosus and not the nucleus pulposus gel. Therefore it’s logical to target and repair annular tears with Fibrin.

  7. The sixth refinement is that all Fibrin is intentionally targeted away from the disc’s center nucleus pulposus gel. Anything introduced into the disc’s center pushes the disc’s center nucleus pulposus gel outwards through annular tears. When the gel contacts the annulus fibrosus, it initiates the “inflammatory cascade” and the “autoimmune response.” This increases sensitivity of disc nerve endings, thus causing disc low back pain. Therefore, repairing disc tears is a logical goal, and avoiding introducing Fibrin or any “mass” into the center of the disc because that worsens matters by displacing the gel outwards. Ironically, all disc stem cell treatments erroneously inject stem cells into the disc’s center, displacing and pushing nuclear gel outwards through annular tears in a deleterious manner.  

  8. When nuclear gel leaks completely through annular tears, it also inflames adjacent spinal nerve roots and tissue causing pain.

  9. Research affirms that Fibrin mechanically seals annular tears, restoring disc strength to normal. Strength is maintained as Fibrin is naturally replaced, molecule per molecule, with normal disc tissue (collagen Type I and II) over the months following the Discseel® Procedure.

  10. The seventh refinement is valuable to most researchers studying stem cells, PRP and other regenerative biologics, because its been shown that those biologics often quickly leak from human and animal discs. However, the seventh refinement seals the annulus fibrosus in the usual manner of the Discseel Procedure, but it’s sealed for the primary purpose of better containing other introduced regenerative biologics into the sealed discs, preventing them from leaking through annular tears. This potentially increases the ability of these biologics to heal discs by containing them in discs, or they may act synergistically with Fibrin, accentuating Fibrin’s healing properties appreciated during the natural healing process.