Hernicore (condoliase) / Seikagaku, Ferring 
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 1 Disease   1 Trial   1 Trial   63 News 
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    Retrospective data, Journal:  Multicenter Retrospective Analysis of Intradiscal Condoliase Injection Therapy for Lumbar Disc Herniation. (Pubmed Central) -  Sep 30, 2022   
    Intradiscal condoliase injection is an effective treatment for LDH, even in patients with large vertebral translation and posterior disc angles, regardless of age. However, since condoliase imposes a risk of progressing disc degeneration, its indication for younger patients remains controversial.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    Clinical, Clinical data, Journal:  Clinical outcome of condoliase injection treatment for lumbar disc herniation: Indications for condoliase therapy. (Pubmed Central) -  Oct 1, 2021   
    Condoliase injection resulted in significantly improved symptoms in patients with LDH. Condoliase therapy was less effective for patients with a history of discectomy, spondylolisthesis, or those with a posterior intervertebral angle ≥5°, while trans-ligamentous type and high T2 herniation were associated with increased efficacy.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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.
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    Trial completion:  A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) -  Mar 9, 2018   
    P3,  N=360, Completed, 
    Trial primary completion date: Mar 2017 --> Feb 2018 Active, not recruiting --> Completed
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    Trial completion:  A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) -  Mar 9, 2018   
    P3,  N=1000, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    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
  • ||||||||||  Hernicore (condoliase) / Seikagaku, Ferring
    Enrollment open:  A Study of SI-6603 in Patients With Lumbar Disc Herniation (clinicaltrials.gov) -  Sep 11, 2013   
    P3,  N=360, Recruiting, 
    Trial primary completion date: Dec 2014 --> Oct 2015 Not yet recruiting --> Recruiting