Kolon Life Sci 
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  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Trial completion date, Trial primary completion date:  A Study to Determine the Safety and Efficacy of TG-C in Subjects with Symptomatic Early Hip Osteoarthritis (clinicaltrials.gov) -  Dec 11, 2024   
    P2,  N=255, Not yet recruiting, 
    Finally, the present study provides insight into the mechanism of action of TG-C in the treatment of OA. Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
  • ||||||||||  KLS-2031 / Kolon Life Sci
    KLS-2031 as a new multimodal gene therapy for painful diabetic peripheral neuropathy (Exhibition Hall/Poster Area) -  Jul 18, 2024 - Abstract #IASP2024IASP_2050;    
    The efficacy of KLS-2031 is attributed to its multi-target approach, which simultaneously modulates several pathologies in the DRG and spinal cord (SC). These results suggest that KLS-2031 is a novel, effective, and promising therapy for PDN.
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Enrollment closed, Trial completion date, Trial primary completion date:  Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) -  Jan 24, 2024   
    P3,  N=511, Active, not recruiting, 
    Trial completion date: Nov 2026 --> Nov 2027 | Trial primary completion date: Nov 2026 --> Nov 2027 Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Feb 2026 | Trial primary completion date: Aug 2024 --> Feb 2024
  • ||||||||||  KLS-2031 / Kolon Life Sci
    Preclinical, Journal:  Combination gene delivery reduces spinal cord pathology in rats with peripheral neuropathic pain. (Pubmed Central) -  Nov 27, 2023   
    PERSPECTIVE: Our study demonstrated that KLS-2031, a combination gene therapy delivered by transforaminal epidural injection, not only mitigates neuroinflammation, but also improves SC neurophysiological function, including excitatory-inhibitory balance. These findings support the potential of KLS-2031 as a novel modality that targets multiple aspects of the complex pathophysiology of neuropathic pain.
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Trial completion date, Trial initiation date, Trial primary completion date:  A Study to Determine the Safety and Efficacy of TG-C in Subjects with Symptomatic Early Hip Osteoarthritis (clinicaltrials.gov) -  Dec 23, 2022   
    P2,  N=255, Not yet recruiting, 
    These findings support the potential of KLS-2031 as a novel modality that targets multiple aspects of the complex pathophysiology of neuropathic pain. Trial completion date: Oct 2023 --> Oct 2024 | Initiation date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2023 --> Oct 2024
  • ||||||||||  KLS-2031 / Kolon Life Sci
    Combination gene delivery reduces spinal cord pathology in rats with peripheral neuropathic pain (SDCC Halls B-H) -  Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_11348;    
    KLS-2031 mitigated neuroinflammation in the SC by regulating microglia and astrocytes. Collectively, KLS-2031 effectively suppressed the central sensitization of pain signals and inflammation in the SC of a NP model and offers a potentially new therapeutic approach for NP.
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Enrollment open, Trial completion date, Trial primary completion date:  A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) -  Dec 16, 2021   
    P3,  N=510, Recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Sep 2021 --> Jun 2025 | Trial primary completion date: Sep 2021 --> Jun 2024 Active, not recruiting --> Recruiting | Trial completion date: Oct 2024 --> Jun 2025 | Trial primary completion date: Oct 2023 --> Jun 2024
  • ||||||||||  KLS-2031 / Kolon Life Sci
    Trial completion date, Trial primary completion date:  Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (clinicaltrials.gov) -  Aug 24, 2021   
    P1/2,  N=18, Recruiting, 
    Active, not recruiting --> Recruiting | Trial completion date: Oct 2024 --> Jun 2025 | Trial primary completion date: Oct 2023 --> Jun 2024 Trial completion date: Nov 2022 --> Sep 2023 | Trial primary completion date: Nov 2021 --> Sep 2022
  • ||||||||||  KLS-2031 / Kolon Life Science
    Journal:  AAV-Mediated Combination Gene Therapy for Neuropathic Pain: GAD65, GDNF, and IL-10. (Pubmed Central) -  Aug 1, 2020   
    Furthermore, KLS-2031 mitigated the neuroinflammation, neuronal cell death, and dorsal root ganglion hyperexcitability induced by the spared nerve injury. These results suggest that KLS-2031 represents a promising therapeutic option for refractory neuropathic pain.
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Enrollment closed, Trial completion date, Trial primary completion date:  A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) -  May 13, 2020   
    P3,  N=510, Active, not recruiting, 
    These results suggest that KLS-2031 represents a promising therapeutic option for refractory neuropathic pain. Suspended --> Active, not recruiting | Trial completion date: Apr 2022 --> Oct 2024 | Trial primary completion date: Apr 2021 --> Oct 2023
  • ||||||||||  Invossa K (tonogenchoncel-L) / Kolon Life Science, Glybera (alipogene tiparvovec) / uniQure, Chiesi, Xenon
    Journal:  The Landscape of Cellular and Gene Therapy Products: Cost, Approvals, and Discontinuations. (Pubmed Central) -  Mar 20, 2020   
    Majority of the gene therapies received orphan designation by the regulatory authorities and had conditional approvals while less than a quarter of cellular therapies received the orphan designation. Most of the gene therapies are approved for rare diseases with smaller patient population, companies find it difficult to make profits which results in market withdrawal of the therapies.
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Enrollment closed:  A Post Marketing Surveillance Study of INVOSSA K Inj. (clinicaltrials.gov) -  May 28, 2019   
    P=N/A,  N=3000, Active, not recruiting, 
    Most of the gene therapies are approved for rare diseases with smaller patient population, companies find it difficult to make profits which results in market withdrawal of the therapies. Recruiting --> Active, not recruiting
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Trial completion date, Trial initiation date, Trial primary completion date:  A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) -  Apr 19, 2018   
    P3,  N=510, Not yet recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: Sep 2021 --> Apr 2022 | Trial primary completion date: Sep 2021 --> Apr 2021 Trial completion date: Jun 2021 --> Sep 2021 | Initiation date: Apr 2018 --> Jul 2018 | Trial primary completion date: Jun 2021 --> Sep 2021
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Trial completion date, Trial initiation date, Trial primary completion date:  Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee (clinicaltrials.gov) -  Apr 19, 2018   
    P3,  N=510, Not yet recruiting, 
    Trial completion date: Jun 2021 --> Sep 2021 | Initiation date: Apr 2018 --> Jul 2018 | Trial primary completion date: Jun 2021 --> Sep 2021 Trial completion date: Jun 2021 --> Sep 2021 | Initiation date: Apr 2018 --> Jul 2018 | Trial primary completion date: Jun 2021 --> Sep 2021
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Enrollment closed, Trial initiation date:  The Efficacy and Safety of Invossa K Injection in Patients Diagnosed With Knee Osteoarthritis (clinicaltrials.gov) -  Mar 7, 2018   
    P3,  N=146, Active, not recruiting, 
    Trial completion date: Jun 2021 --> Sep 2021 | Initiation date: Apr 2018 --> Jul 2018 | Trial primary completion date: Jun 2021 --> Sep 2021 Not yet recruiting --> Active, not recruiting | Initiation date: Jan 2018 --> Feb 2018
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Trial completion:  Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis (clinicaltrials.gov) -  Sep 2, 2015   
    P3,  N=163, Completed, 
    Not yet recruiting --> Active, not recruiting | Initiation date: Jan 2018 --> Feb 2018 Active, not recruiting --> Completed
  • ||||||||||  Invossa (tonogenchoncel-L) / Kolon Life Sci
    Enrollment closed:  Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis (clinicaltrials.gov) -  Aug 21, 2014   
    P3,  N=156, Active, not recruiting, 
    Active, not recruiting --> Completed Recruiting --> Active, not recruiting