Status:
ACTIVE_NOT_RECRUITING
Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee
Lead Sponsor:
Kolon TissueGene, Inc.
Conditions:
Degenerative Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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,...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2026
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT03291470
Start Date
December 9 2021
End Date
March 6 2026
Last Update
December 30 2025
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Nebojsa Skrepnik
Tucson, Arizona, United States, 85712
2
Steve Sitar
Anaheim, California, United States, 92801
3
Stuart Silverman
Beverly Hills, California, United States, 90211
4
Samy Metyas
Covina, California, United States, 91722