TG-C for Osteoarthritis of the Knee
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests TG-C, an injection into the knee, for patients with moderate to severe osteoarthritis. It aims to reduce pain and improve knee function by potentially modifying the disease. TG-C has shown promise in previous studies for managing knee osteoarthritis.
Will I have to stop taking my current medications?
The trial requires that you stop taking NSAIDs (non-steroidal anti-inflammatory drugs) 14 days before the study and steroidal anti-inflammatory medications 2 months before the study. Chronic narcotic use is also not allowed.
Is TG-C safe for humans?
How is the treatment TG-C for knee osteoarthritis different from other treatments?
TG-C is unique because it is specifically designed for osteoarthritis of the knee, potentially offering a novel approach compared to traditional treatments like glucocorticoid injections or hyaluronic acid, which focus on reducing inflammation or lubricating the joint. While the exact mechanism of TG-C is not detailed, it may offer a new option for patients who do not respond well to existing therapies.678910
What data supports the effectiveness of the treatment TG-C for osteoarthritis of the knee?
Who Is on the Research Team?
Moon Jong Noh, PhD
Principal Investigator
Kolon TissueGene, Inc.
Are You a Good Fit for This Trial?
This trial is for adults aged 40 or older with moderate knee osteoarthritis (Grade 2 or 3), not too thin or overweight, and experiencing significant pain. Participants must consent to the study's terms and use birth control if applicable. Exclusions include severe knee swelling, certain MRI findings, recent injections in the knee, other serious health conditions, drug/alcohol abuse history, and specific medications taken recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intra-articular injection of TG-C or placebo
Follow-up
Participants are monitored for safety and efficacy after treatment
Long-term follow-up
Annual cancer surveillance questionnaires through 15 years post dosing for subjects not in the Long Term Safety study
What Are the Treatments Tested in This Trial?
Interventions
- Placebo Control
- TG-C
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kolon TissueGene, Inc.
Lead Sponsor