Clinical Trial 40089

New York, NY 10022

Study Summary:

   Protocol TGC12301 is a randomized, double-blinded, placebo-controlled, multi-center phase III study. A total of 510 adults will be enrolled and randomized in a 2:1 manner, with 340 treated subjects and 170 placebo subjects, with radiographically determined stage 2 or 3 primary osteoarthritis of the knee joint. All study subjects will be followed for a period of 24 months, (104 weeks) after injection. During participation in the study, if there is no relief from symptoms, subjects may choose to undergo a surgical procedure including (total knee arthroplasty) 12 months or more after dosing at their own discretion in consultation with the investigator.

Qualified Participants Must:

• Be age 40 and older
• Have Osteoarthritis of the knee
• Have a BMI between 18.5 and 40
• Be able to provide current MRI of target knee

Qualified Participants May Receive:

  • Qualified participants will receive randomization treatment for knee pain by injection.
  • Follow up and assessment of knee after injection for a period of 24 months.
  • Potential Reimbursement if qualified for the study (at discretion of study sponsor. )

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.