Dr. Calodney, interventional pain specialist with Precision Spine Care, was the investigator in the pivotal study, with Dr. Kevin Pauza, to examine the safety and efficacy of the Biostat Biologx Fibrin Sealant in the treatment of chronic discogenic low back pain resulting from Internal Disc Disruptions.
Chronic low back pain related to discs is caused from repeated injury to disc tissue. There is little blood supply to lumbar discs, which slows the healing process when tears and cracks form with time. Injured discs can be incredibly painful, including chronic inflammation and nerve aggravation.
Naturally, the body knows how to heal – although the process may be arduous for disc repair. The first step in healing includes bleeding. Regenerative and inflammatory cells help the immediate wound by cleaning it through blood. The bleeding stops when plasma reaches damaged tissue – thereby coagulating, or creating a fibrin clot. This allows the wound to close and create new tissue.
Now that the wound has been closed through plasma – think of a scab – bacteria and damaged tissue are expelled. This moves the wound to a proliferation phase – when new blood vessels and nerves grow. These new structures also provide new healthy cells, and more nutrition to the area. The new tissue then breaks down the fibrin clot – or scab – replacing it with new, healthy tissue. Finally, for a wound to heal, scar tissue develops to provide additional protection to the area.
While this healing process may take only a few weeks for a cut knee – fall, bleed, scab, scar develops, healed – it takes much longer for discs because of the limited blood supply. During the first two stages of healing, it is not uncommon for damaged tissue to gather in a disc causing chronic inflammation. This can stop the next phase of healing – soft tissue repair.
BIOSTAT BIOLOGX® Fibrin Sealant is a biologic sealant and adhesive comprised of highly-purified human fibrinogen and thrombin, the two essential blood proteins involved in the formation of a fibrin clot. This technology was designed to deliver essential blood proteins to where an injured disc needs them most. This fibrin sealant advances the natural healing process.
BIOSTAT BIOLOGX® Fibrin Sealant functions as a physical barrier between inflammatory substances in the disc and nerves within the fissures, and also serves as a restorable tissue scaffold. The application of the sealant may reduce pain by decreasing inflammation and improving tissue repair.
Phase III clinical studies are occurring to study the Biostat System. Such studies will determine if this fibrin sealant technology improves chronic low back pain related to disc injury. To learn more about the study at please call: 903-225-2893
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