EARLY FIBRIN STUDY VS NEW

PROCEDURE REFINEMENTS TO EDUCATE PHYSICIANS

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 benefits of Discseel®️ Procedure over the basic stem cell treatments. Our Physician training program for the Discseel®️ Procedure is highly competitive, and currently there are several hundred Physician Applicants for each position available.

This document details important refinements of the Discseel®️ Procedure, and dispels misunderstandings perpetuated by those unfamiliar with important refinements which improve the Discseel®️ Procedure’s efficacy. 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; and
  4. One especially unique attribute is that 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. A key benefit of the Discseel®️ Procedure is that it allows the nucleus of the disc to retain critical biologics.

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 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 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 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. 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 injection therapy clinics/franchises, including the Colorado-based stem cell franchise, run by Dr. Centeno. Annulograms show that most patients 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. 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. 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. Our final refinement to the original study protocol is valuable to most researchers studying stem cells, PRP, an other regenerative biologics, because it has been shown that those biologics often quickly leak from human and animal discs. However, our approach seals the annulus fibrosus in the usual manner of the Discseel®️ Procedure, but it is sealed for the primary purpose to contain other introduced regenerative biologics into the now 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.
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