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Journal: Efficacy of Chemonucleolysis with Condoliase in Patients Aged under 20 Years. (Pubmed Central) - Oct 14, 2024 Caution should be taken when managing cases showing lumbar instability or existing disability. While chemonucleolysis with condoliase is a less invasive treatment option for LDH, the administration should be decided upon with sufficient consent considering the potential limited efficacy and disk degeneration.
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Review, Journal: Treatment Gaps and Emerging Therapies in Lumbar Disc Herniation. (Pubmed Central) - Oct 3, 2024 While chemonucleolysis with condoliase is a less invasive treatment option for LDH, the administration should be decided upon with sufficient consent considering the potential limited efficacy and disk degeneration. The lack of sustained benefits associated with ESIs and the risks associated with surgery underscore the unmet need for novel, minimally invasive interventional therapies able to address the underlying nerve root compression in LDH.
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Clinical data, Journal: Psychological Factors Can Affect the Clinical Outcome of Chemonucleolysis with Condoliase in Patients with Lumbar Disk Herniation. (Pubmed Central) - Apr 15, 2024 Group I demonstrated significantly higher baseline back pain VAS, HADS, and HADS-D scores when compared with Group E. Logistic regression analysis identified females and the baseline HADS-D score as independent factors that were related to the effectiveness of condoliase therapy. The patients with psychological factors tended to experience residual pain resulting in adverse effects on the clinical outcomes of chemonucleolysis with condoliase.
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Biomarker, Journal: Predictive Factors for Poor Outcome following Chemonucleolysis with Condoliase in Lumbar Disc Herniation. (Pubmed Central) - Dec 24, 2022 Receiver-operating characteristics curve analysis for accompanying calcification or ossification showed an area under the curve of 0.858 (95% confidence interval, 0.715-1.000; p = 0.001). Calcified or ossified disc herniation may be useful predictors of unsuccessful treatment in patients with condoliase administration.
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Clinical data, Journal: Condoliase therapy for lumbar disc herniation -2 year clinical outcome. (Pubmed Central) - Nov 25, 2022 Chemonucleolysis-induced disc degeneration was slightly recovered and maintained for two years post-injection. This treatment resulted in high patient satisfaction and recommendations.
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Preclinical, Journal: Effect of contrast media on the enzyme activity of condoliase: In vitro assessment. (Pubmed Central) - Oct 8, 2022 Although the nonionic contrast media did not affect condoliase activity in the presence of CS, it reduced activity in the absence of CS. Mixing condoliase with contrast media, especially ionic type contrast media, should be avoided.
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Enrollment closed, Trial completion date, Trial primary completion date: SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study) (clinicaltrials.gov) - Apr 29, 2022 P3, N=320, Active, not recruiting, However, because the study had several limitations, such as large loss of follow-up, further research is needed. Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Jul 2022
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Clinical, Journal: Short-Term Outcome and Predictors of Therapeutic Effects of Intradiscal Condoliase Injection for Patients with Lumbar Disc Herniation. (Pubmed Central) - Aug 27, 2021 Intradiscal condoliase injection had a good short-term therapeutic effect in patients with LDH, including in transligamentous extrusion-type and revision cases as well as subligamentous extrusion-type cases. Administration of intradiscal condoliase injection may be most effective in patients with a larger herniated mass volume before treatment, and least effective in cases with a longer time and less intervertebral disc degeneration before treatment.
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Journal: Selective Chemonucleolysis With Condoliase in Cynomolgus Monkeys. (Pubmed Central) - May 27, 2021 The degrees of the changes in the IVD and VB were more severe than those of condoliase, and the changes were exacerbated even at week 26. These results indicated that histopathological changes caused by condoliase were less severe and more selective than those by chymopapain.
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Review, Journal: Evolving Pharmacotherapies for Pain: Drug Development. (Pubmed Central) - Dec 17, 2020 Chronic pain disproportionately affects certain populations including women, low-income individuals, and older adults. This article focuses primarily on new molecular entities in development targeting various chronic pain receptors and new delivery technologies.
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Trial completion date, Trial primary completion date: SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study) (clinicaltrials.gov) - Nov 15, 2019 P3, N=320, Recruiting, This article focuses primarily on new molecular entities in development targeting various chronic pain receptors and new delivery technologies. Trial completion date: Nov 2020 --> Nov 2022 | Trial primary completion date: Feb 2020 --> Feb 2022
- |||||||||| Condoliase (SI-6603) / Seikagaku, Ferring
Journal: Condoliase for treatment of lumbar disc herniation. (Pubmed Central) - May 14, 2019 Condoliase (chondroitin sulfate ABC endolyase), a glycosaminoglycan-degrading enzyme, was approved by the drug regulatory authority in Japan as a newer intradiscal therapy for LDH after clinical studies conducted in Japan demonstrated efficacy and safety for patients with LDH. This review will focus on the preclinical pharmacology, pharmacokinetics, efficacy and safety of condoliase as a new option for treatment of LDH.
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Trial primary completion date: A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) - Apr 2, 2018 P3, N=1011, Completed, This review will focus on the preclinical pharmacology, pharmacokinetics, efficacy and safety of condoliase as a new option for treatment of LDH. Trial primary completion date: Mar 2017 --> Feb 2018
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Enrollment closed, Trial primary completion date: A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) - Sep 13, 2016 P3, N=1000, Active, not recruiting, Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Mar 2017
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Enrollment closed: A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) - Aug 27, 2015 P3, N=360, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Mar 2017 Recruiting --> Active, not recruiting
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Trial primary completion date: A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) - Jul 23, 2014 P3, N=360, Recruiting, Recruiting --> Active, not recruiting Trial primary completion date: Dec 2014 --> Oct 2015
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