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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Degenerative Osteoarthritis

In brief

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.

Key facts

Study ID

NCT03203330

Run by

Kolon TissueGene, Inc.

People needed

535

Starts

2018-10-30

Expected to finish

2026-07-10

Last updated by the study team

2025-12-30

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 40 or older
• BMI between 18.5 and 40
• KL Grade 2 or 3 knee OA
• OARSI Grade 1 or 2 medial JSN
• Pain >= 40 on VAS scale
• Written informed consent
• Using birth control

You may not qualify if…

• 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
• Has received injection to target knee within 2 months prior to study entry
• History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune OA, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
• Severe hip osteoarthritis ipsilateral to the target knee
• Ongoing infection disease including but not limited to HIV, Hepatitis B or C.
• Clinically significant congestive heart failure hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder
• Uncontrolled diabetes based on a HbA1c > 8% at screening

Where it is running

• Jeffrey Davis — Birmingham, Alabama, United States
• Bradly Goodman — Birmingham, Alabama, United States
• Saima Chohan — Phoenix, Arizona, United States
• Nebojsa Skrepnik — Tucson, Arizona, United States
• Diraj Karnani — Apple Valley, California, United States
• Dan La — Covina, California, United States
• Scott Hacker — La Mesa, California, United States
• Eric Grigsby — Napa, California, United States
• Arthur Mabaquiao — San Diego, California, United States
• Timothy Davis — Santa Monica, California, United States
• Tien-I Su — Whittier, California, United States
• Mehul Desai — Washington D.C., District of Columbia, United States
• David Billmeier — Daytona Beach, Florida, United States
• Mercedes Ponce De Leon — Miami, Florida, United States
• Aurelio Torres-Consuegra — Miami, Florida, United States
• Edgar Gonzalez — Miami, Florida, United States
• Cathy Barnes — New Port Richey, Florida, United States
• Howard Chipman — Oldsmar, Florida, United States
• Richard Linn — Sunrise, Florida, United States
• Anand Patel — Winter Park, Florida, United States
• Sandeep Vaid — Newnan, Georgia, United States
• Dennis Levinson — Chicago, Illinois, United States
• Manish Jain — Chicago, Illinois, United States
• Hythem Shadid — Oak Brook, Illinois, United States
• Adil Fatakia — Marrero, Louisiana, United States

Full record on ClinicalTrials.gov

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