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:
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Conditions: Knee Osteoarthritis
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Age: Between 40 years - 100 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Provide written informed consent
- Have Grade 2 or 3 primary osteoarthritis of the target knee, as determined by the radiographic criteria of Kellgren and Lawrence
- 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:
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- Human immunodeficiency virus (HIV) positive
- Has Human Tlymphotropic virus 1 (HTLV-1)
- Has vesicular stomatitis virus (VSVG)
- Has New York Heart Association (NYHA) Class II to IV congestive heart failure
- Acute or chronic hepatic disease (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) greater than 3 times the upper limit of normal [ULN])
- Has chronic kidney disease
- Has adrenal insufficiency or Cushing’s syndrome
- Acromegaly
- Uncontrolled hyper- or hypothyroidism
- Non-specified uncontrolled endocrine disorder
- Uncontrolled diabetes (hemoglobin A1c [HbA1c ] > 8%)
- 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)
- Contraindication for undergoing magnetic resonance imaging (MRI)
- Steroid or other knee injections within the past 2 months
- Women who are pregnant or lactating
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.