CompletedPhase 3

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

United States531 participantsStarted 2021-12-09

Plain-language 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 ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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, squamo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)

Timeframe: 12 months

Change in Knee Pain as Assessed by VAS

Timeframe: 12 months

Trial details

NCT IDNCT03291470

SponsorKolon TissueGene, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-06

View on ClinicalTrials.gov More Degenerative Osteoarthritis trials