Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee

Completed · 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 efficacy and safety 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

NCT03291470

Run by

Kolon TissueGene, Inc.

People needed

531

Starts

2021-12-09

Expected to finish

2026-05-01

Last updated by the study team

2026-07-07

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
• 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 or biologic therapy 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 disorder, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
• Severe hip osteoarthritis ipsilateral to the target knee
• Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or HCV.
• 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.
• Documented active malignancy within the last 5 years except for basal cell carcinoma, squamous cell carcinoma, and benign pigmented nevi.

Where it is running

• Nebojsa Skrepnik — Tucson, Arizona, United States
• Steve Sitar — Anaheim, California, United States
• Stuart Silverman — Beverly Hills, California, United States
• Samy Metyas — Covina, California, United States
• Bassil Aish — Huntington Beach, California, United States
• Peter Hanson — La Mesa, California, United States
• Duane Anderson — San Diego, California, United States
• Miguel Trevino — Clearwater, Florida, United States
• Jan Hommen — Doral, Florida, United States
• Mira Baron — West Palm Beach, Florida, United States
• Richard Radnovich — Boise, Idaho, United States
• Thomas Schnitzer — Chicago, Illinois, United States
• Nathan Rimmke — Rochester Hills, Michigan, United States
• Larkin Wadsworth — St Louis, Missouri, United States
• Robby Ann Quintos — Las Vegas, Nevada, United States
• Igor Grosman — Brooklyn, New York, United States
• Jonathan Samuels — New York, New York, United States
• Minal Desai — Durham, North Carolina, United States
• Jeremy Hoff — Wilmington, North Carolina, United States
• Priyesh Mehta — Dayton, Ohio, United States
• Edward Tavel — Charleston, South Carolina, United States
• Durga Tanneru — Dallas, Texas, United States
• Manjoo Sharma — Lewisville, Texas, United States
• Haresh Boghara — Red Oak, Texas, United States
• Leonel Reyes — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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