A Randomized Double-Blind Placebo-Controlled Multi-Center Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Knee Osteoarthritis
  • Age: Between 40 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Provide written informed consent
    2. Have Grade 2 or 3 primary osteoarthritis of the target knee, as determined by the radiographic criteria of Kellgren and Lawrence
    3. Have a score of = 40 on the 100 mm pain VAS of the target knee

You may not be eligible for this study if the following are true:

    1. Human immunodeficiency virus (HIV) positive
    2. Has Human Tlymphotropic virus 1 (HTLV-1)
    3. Has vesicular stomatitis virus (VSVG)
    4. Has New York Heart Association (NYHA) Class II to IV congestive heart failure
    5. Acute or chronic hepatic disease (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) greater than 3 times the upper limit of normal [ULN])
    6. Has chronic kidney disease
    7. Has adrenal insufficiency or Cushing’s syndrome
    8. Acromegaly
    9. Uncontrolled hyper- or hypothyroidism
    10. Non-specified uncontrolled endocrine disorder
    11. Uncontrolled diabetes (hemoglobin A1c [HbA1c ] > 8%)
    12. Co-morbid conditions that are known to increase the risk of cancer (genetic mutations such as BRCA1/2, Lynch syndrome, Cowden syndrome, Li Fraumeni syndrome, Von Hippel-Lindau disease, multiple endocrine neoplasia, Crohn’s disease, ulcerative colitis, multiple sclerosis or other known conditions with predisposition for higher risk of cancer)
    13. Contraindication for undergoing magnetic resonance imaging (MRI)
    14. Steroid or other knee injections within the past 2 months
    15. Women who are pregnant or lactating



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