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Intra-annular Fibrin Discseel®

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Regenerative Medicine

Abstract

Through utilizing evidence-based medicine, the Discseel® Procedure supersedes the safety and efficacy of earlier treatments attempting to relieve chronic low back pain, chronic neck pain, and extremity radiculopathy. The Discseel® Procedure is composed of two sequentially performed steps: first, annulograms test all discs for annular tears in the region of symptoms, and second, nonautologous fibrin is injected into those annular tears of all morphologically abnormal intervertebral discs (discs) and into annulogram needle puncture holes of all tested discs. The Discseel® Procedure differs from other regenerative medicine procedures in that it meets the criteria allowing protection of its intellectual property (I.P.) through an Act of Congress. This I.P. protection assures that only physicians who are trained and licensed may perform the Discseel® Procedure. In comparison, no spinal surgery and no “stem cell” or other injection procedure possess such attributes allowing for their protection.

The Discseel® Procedure provides greater safety and efficacy than all surgical and nonsurgical spine treatments attempting to treat multilevel, chronic low back pain, with or without radiculopathy. In a prospective study pending publication and presented at AAOM (American Academy of Orthopedic Medicine), 373 subjects demonstrated statistically significant improvement of all critical outcomes, including pain, function, disability, mental health, and quality of life over a 24-month period. To assure research credibility and mitigate controversy, investigators utilized the OBERD Registry, the only registry endorsed by the American Academy of Orthopedic Surgery. Furthermore, this study enrolled subjects who were predisposed to fail based on their history. At a minimum, to enroll, subjects must have first failed conservative chiropractic or physical therapy, followed by treatments including stem cell injections (performed by physicians utilizing strict protocols); epidural injections of corticosteroids; or spinal surgery fusion, arthrodesis, or discectomy. No subject was lost to follow-up, and none experienced any adverse event.

The Discseel® Procedure eliminates flaws inherent to most, if not all, regenerative medicine procedures attempting to treat discs. These flaws include (1) injecting biologics into disc centers, which causes the outward displacement of NP (nucleus pulposus) and associated inflammatory constituents from those treated discs, instead of containing NP and associated noxious constituents within treated discs, as is necessary. Unfortunately, all other treatments injecting “stem cells,” PRP, or anything into the center of discs unfortunately displaces NP outward, opposite the desired goal, and all other disc regenerative medicine treatments. (2) Flawed methodology includes not targeting the AF, especially because it is now agreed that pathology (and disc innervation) resides only within the AF.

Chronic low back pain is the most common cause of disability, and lumbar discs are the most common cause of chronic low back pain. The Discseel® Procedure is defined as the two-step process: introducing nonautologous fibrin, intra-annularly, to treat annular defects (tears), which, directly or indirectly, cause all chronic low back pain. An annulogram is a dynamic test, which easily identifies annular defects (tears) by allowing observation of contrast flow patterns through the 22–25 annular layers of the injected AF being tested. Annulograms possess significantly greater sensitivity than MRIs in identifying annular defects (tears). A normal appearing MRI is often seen in patients with pain whose annulogram clearly demonstrates annular defects. Annulograms are dynamic, analogous to coronary arteriograms, which are also dynamic and coincidentally fraught with skepticism before their widespread acceptance, forever changing the paradigm evaluating CAD. Favorable results of all published and ongoing investigations suggest that annulograms should become the mainstay in spine treatment because annulograms solely possess the ability to accurately diagnose spines, thus allowing a greater likelihood of treatment success. Published in vivo investigations show that fibrin mechanically repairs annular defects (tears) and, incredibly, fibrin stimulates new disc growth, returning discs’ biochemical and mechanical properties to normal.

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Authors and Affiliations

  1. Baylor Scott and White, Texas Spine and Joint Hospital, Tyler, TX, USA

    Kevin Joseph Pauza

  2. Regenerative Sportscare Institute, Senior Physician, New York, NY, USA

    Kevin Joseph Pauza

  3. Interventional Physiatrist, iSCORE (Interventional Spine Care and Orthopedic Regenerative Experts, PC), Arcadia, CA, USA

    Maxim Moradian

  4. Hospital for Special Surgery, Regenerative Sports Care Institute, New York, NY, USA

    Gregory Lutz

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  1. Kevin Joseph Pauza
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Editors and Affiliations

  1. Ainsworth Institute of Pain Management, Mount Sinai Hospital Ainsworth Institute of Pain Management, New York, NY, USA

    Corey W Hunter

  2. Source Healthcare and Source Surgery Center, Santa Monica, CA, USA

    Timothy T. Davis

  3. Virginia iSpine Physicians, Richmond, VA, USA

    Michael J. DePalma

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Pauza, K.J., Moradian, M., Lutz, G. (2023). Intra-annular Fibrin Discseel®. In: Hunter, C.W., Davis, T.T., DePalma, M.J. (eds) Regenerative Medicine . Springer, Cham. https://doi.org/10.1007/978-3-030-75517-1_6

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