Autologous (from our own body) stem cell use requires the harvest of large numbers of cells with subsequent use of special laboratory techniques for clonal expansion (multiply) to a differentiated (specialized) nuclear chondrocyte cells (the cells that regenerate our disc material). Stem cell use has become the object of media frenzy, stoking, both public and research interests, due to the potential for tissue regeneration. Fibrin sealant did not demonstrate a satisfactory level of efficacy versus placebo and has not become the standard of care. This larger multi-centre RCT was stopped after 6 months due to the fact early results were disappointing. ![]() Unfortunately, the Phase III trial for fibrin sealant did not meet expectations. Tremendous excitement was generated from this study. Clinically significant improvements in pain and function were demonstrated at 24 months follow up. In 2014, results from a multi-centre randomized controlled trial (RCT) demonstrated the efficacy of this fibrin sealant compared with placebo. Initial data suggested intradiscal fibrin sealant injection might improve pain and function in selected patients with IDDS. These patients had “failed” conservative therapy and were deemed appropriate for this study after provocation. The original study included 15 adults with chronic axial low back pain (CLBP). Provocative Discography at 元-4, L4-5, L5-S1 Essentially, it functions as a physical barrier between inflammatory substances in the disc and nerves within the fissures, and serves as a scaffold for tissue repair.įigure X. The sealant occludes the anular fissures and lays down a tissue repair matrix. The purpose of this study was to assess the safety and preliminary efficacy of BIOSTAT BIOLOGX® Fibrin Sealant in human adults with chronic symptomatic lumbar internal disc disruption (IDD). ![]() Select patients will have a encouraging prognosis for responding and therefore a favorable benefit:risk profile Fibrin Sealant (Fibrin sealant information is for history and education only)Īt the 17th Annual Scientific Meeting of the International Spine Intervention Society (ISIS) an abstract entitled “Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter IDE pilot study with 6-month follow-up” was presented by authors Way Yin, MD et al. That being said, the early data suggests there is a sub-section of patients for whom this type of intervention can be quite effective. These words of caution are to be respected. Given the poorly regulated and rapidly expanding US direct-to-consumer stem cell industry, high quality explanatory trials are needed to better assess the true effectiveness of these treatments.” According to GRADE the published evidence supporting the use of intradiscal MSCs and PRP is of very low quality. ![]() For MSC therapies, depending on how loss-to-follow-up is counted, success rates of >50%improvement in LBP at six months were 23/43 (53.5%, 95% CI: 38.6%−68.4%) (as reported) or 23/59 (39.0%, 95% CI: 26.5-51.4%) (worst-case analysis) at six months. When aggregation of data was possible, 22/42 (52.4%, 95% CI: 37%−67%) study participants achieved >50% relief of LBP following intradiscal injection of PRP with a minimum follow-up of six months. In their conclusions they wrote, “When appropriate inclusion criteria were applied, some observational data suggests that intradiscal biologic agents may be effective treatments for discogenic LBP. Systematic Review/Meta-Analysis The effectiveness of intradiscal biologic treatments for discogenic low back pain: a systematic review Schneider BJ et al). While the problem remains unsolved, science is creeping closer everyday.Ī recent review/meta-analysis by our colleagues at the Spine Intervention Society (SIS) provided a reasonable synopsis of the state of the literature heading into 2022 ( The Spine Journal 22 (2022). Scientific studies are ongoing for the development of medical compounds that actually “heal” disc degeneration/injury. This category refers to the Holy Grail of spine medicine.
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