Discogenic chronic low back pain is believed to result from poor healing of damaged disc tissues which accumulate over time. Since the lumbar intervertebral discs have a very limited blood supply, the tears and cracks which form within the disc heal very slowly and essentially become painful, chronically inflamed wounds within the disc structure.
Natural Soft Tissue Healing Process
Normal soft tissue healing occurs through a series of intertwined processes. Throughout the cascading process there are events associated with each phase that stimulate the following phases.
The first stage of tissue repair occurs at the time of injury and involves bleeding. The purpose of bleeding is to provide regenerative and inflammatory cells, as well as to assist in the cleansing of the wound.
Bleeding halts when components in blood plasma contact damaged tissues. This process initiates blood coagulation and the formation of a fibrin clot, which seals the wound and provides the scaffolding upon which cells build new tissues.
In the inflammatory phase, bacteria and damaged tissue debris are removed. This process releases factors that attract cells involved in the proliferation phase.
The proliferation phase is characterized by angiogenesis (formation of blood vessels) and nerve growth. These newly formed blood vessels also support the recruitment of tissue repair cells and provide nutrition to support their function.
In the tissue repair phase cells begin to break down the fibrin clot and replace it with a new repair material called granulation tissue.
The final phase of wound healing, tissue remodeling, involves the replacement of granulation repair tissue with stronger and more highly organized scar tissue.
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The human intervertebral disc has an extremely limited blood supply. As a result, the first two critical phases of the soft tissue healing cascade are impaired and damaged tissue accumulates within the disc. The disc then becomes chronically inflamed, thereby impairing the next phases of the soft tissue repair process.
Potential Role of BIOSTAT BIOLOGX Fibrin Sealant
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. The Biostat® Delivery Device has been specifically designed to mix and deliver these components to painful internal disruptions within the disc where they react to form a dense fibrin matrix. The resulting fibrin sealant is nearly identical to the naturally occurring fibrin matrix which the body forms during the earliest stages of wound healing.
Application of BIOSTAT BIOLOGX Fibrin Sealant into a disrupted disc occludes the anular fissures and lays down a natural tissue repair matrix. 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 resorbable tissue scaffold. Application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may alleviate pain by sealing the painful disruptions, reducing inflammation and enhancing tissue repair.
Spinal Restoration is conducting a Phase III clinical study of the Biostat System to determine if application of BIOSTAT BIOLOGX Fibrin Sealant to the disc may provide pain relief for patients suffering from discogenic chronic low back pain. To learn more about our clinical trial, please visit our Clinical Trials page.