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 (NCT03203330)
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee
🩺 Plain-English Summary (8th-Grade Level)
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the safety and efficacy of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (19 items).
Location: Jeffrey Davis — Birmingham, Alabama
Age range: 40 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Knee symptoms that result in difficulty or inability to walk
- Knee effusion \>2+
- Has Grade 3 OARSI JSN
- Has a score of 0 or \>=5 on the cartilage feature of the WORMS at Screening
- MRI exam indicates fracture or tumor
- Has a positive result on RCR testing at Screening
- Has taken NSAIDS with 14 days of baseline
- Has taken steroidal anti-inflammatory medication within 2 months of baseline
- Chronic (\>21 days) narcotic use
- Recent history (within 1 year) of drug or alcohol abuse
- Pregnant or lactating
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (44 Sites)
Showing the first 25 of 44 sites.
- Jeffrey Davis — Birmingham, Alabama
- Bradly Goodman — Birmingham, Alabama
- Saima Chohan — Phoenix, Arizona
- Nebojsa Skrepnik — Tucson, Arizona
- Diraj Karnani — Apple Valley, California
- Dan La — Covina, California
- Scott Hacker — La Mesa, California
- Eric Grigsby — Napa, California
- Arthur Mabaquiao — San Diego, California
- Timothy Davis — Santa Monica, California
- Tien-I Su — Whittier, California
- Mehul Desai — Washington D.C., District of Columbia
- David Billmeier — Daytona Beach, Florida
- Mercedes Ponce De Leon — Miami, Florida
- Aurelio Torres-Consuegra — Miami, Florida
- Edgar Gonzalez — Miami, Florida
- Cathy Barnes — New Port Richey, Florida
- Howard Chipman — Oldsmar, Florida
- Richard Linn — Sunrise, Florida
- Anand Patel — Winter Park, Florida
- Sandeep Vaid — Newnan, Georgia
- Dennis Levinson — Chicago, Illinois
- Manish Jain — Chicago, Illinois
- Hythem Shadid — Oak Brook, Illinois
- Adil Fatakia — Marrero, Louisiana
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.