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Clinical Trial NCT03291470 for Degenerative Osteoarthritis is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee Phase 3 531 Randomized Double-Blind Placebo-Controlled Multi-Center
Clinical Trial NCT03291470 is designed to study Treatment for Degenerative Osteoarthritis. It is a Phase 3 interventional study that is active, not recruiting, having started on 9 December 2021, with plans to enroll 531 participants. Led by Kolon TissueGene, Inc., it is expected to complete by 6 March 2026. The latest data from ClinicalTrials.gov was last updated on 30 December 2025.
Brief Summary
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 ult...Show More
Detailed Description
This protocol is designed to assess the safety and efficacy of TG-C in treating symptoms of osteoarthritis of the knee and determining disease modifying effects of TG-C. This study is intended for the treatment of patients with K&L Grade 2 and 3 osteoarthritis and OARSI JSN Grade 1 and 2. Assessments will be made on both the symptomatic effects of pain (VAS), function (WOMAC), and Quality of Life (SF-12) as well as ...Show More
Official Title
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
Conditions
Degenerative OsteoarthritisOther Study IDs
- TGC-15302
NCT ID Number
Start Date (Actual)
2021-12-09
Last Update Posted
2025-12-30
Completion Date (Estimated)
2026-03-06
Enrollment (Estimated)
531
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Keywords
knee
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorActive Treatment (TG-C) TG-C at 3 x 10e7 cells per single 2 mL intraarticular injection | TG-C 2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1 |
Placebo ComparatorPlacebo Control (Normal Saline) Normal saline, single 2 mL intraarticular injection | Placebo Control 2 mL normal saline intraarticular injection |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC) | Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme. | 12 months |
Change in Knee Pain as Assessed by VAS | Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain. | 12 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
MRI Assessment of Target Knee | Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS) | 12 months |
PCS of the SF-12 Questionnaire | Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire. | 12 months |
WOMAC Total Score | Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score | 24 Months |
Health Assessment Questionnaire Disability Index | Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI) | 12 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
All
- 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
- 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.
Kolon TissueGene, Inc.No contact data.
27 Study Locations in 1 Countries
Arizona
Nebojsa Skrepnik, Tucson, Arizona, 85712, United States
California
Steve Sitar, Anaheim, California, 92801, United States
Stuart Silverman, Beverly Hills, California, 90211, United States
Samy Metyas, Covina, California, 91722, United States
Bassil Aish, Huntington Beach, California, 92647, United States
Peter Hanson, La Mesa, California, 91942, United States
John Beckes, San Diego, California, 92120, United States
Florida
Miguel Trevino, Clearwater, Florida, 33756, United States
Jan Hommen, Doral, Florida, 33126, United States
Mira Baron, West Palm Beach, Florida, 33409, United States
Idaho
Richard Radnovich, Boise, Idaho, 83713, United States
Illinois
Thomas Schnitzer, Chicago, Illinois, 60611, United States
Michigan
Nathan Rimmke, Rochester Hills, Michigan, 48307, United States
Missouri
Larkin Wadsworth, St Louis, Missouri, 63141, United States
Nevada
Duane C Anderson, Las Vegas, Nevada, 89109, United States
New York
Igor Grosman, Brooklyn, New York, 11235, United States
Jonathan Samuels, New York, New York, 10016, United States
North Carolina
Minal Desai, Durham, North Carolina, 27704, United States
Jeremy Hoff, Wilmington, North Carolina, 28412, United States
Ohio
Priyesh Mehta, Dayton, Ohio, 45432, United States
South Carolina
Edward Tavel, Charleston, South Carolina, 29406, United States
Texas
Sefanit Gebretsadik, Dallas, Texas, 75230, United States
Manjoo Sharma, Lewisville, Texas, 75057, United States
Haresh Boghara, Red Oak, Texas, 75154, United States
Leonel Reyes, San Antonio, Texas, 78215, United States
Lisa Blair, San Antonio, Texas, 78229, United States
Washington
David Scott, Spokane, Washington, 99218, United States