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NCT Number: NCT03203330

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

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.

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Key information

Conditions

Degenerative Osteoarthritis Joint Diseases Musculoskeletal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bradly Goodman, Birmingham, Alabama, United States

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About this study

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 KL 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 the physical effects (JSW, MRI evaluations of whole knee joint organ tissues and structure) and biochemical biomarkers. This is a placebo-controlled study, TG-C will be compared to normal saline as a control. Additionally, this protocol is designed to evaluate the safety of TG-C. Safety will be evaluated by observation of the injection site for irritation or other effects, the incidence and severity of adverse events, and changes in physical examination findings, radiographic criteria, and laboratory tests. Patients will be followed for 24 months for both safety and efficacy with annual cancer surveillance questionnaires through 15 years post dosing for subjects who do not enroll in the Long Term Safety study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

TG-C

Biological

2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.

Other names: TissueGene-C

Placebo control

Biological

2 mL normal saline injection

Other names: Normal Saline

Primary outcomes

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

    Time frame: 12 months

    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.

  2. Change in Knee Pain as Assessed by VAS

    Time frame: 12 months

    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.

Secondary outcomes

  1. MRI Assessment of Target Knee

    Time frame: 12 months

    Evaluation of the features of OA, as determined by structural changes of the knee joint, assessed by MRI

  2. PCS of the SF-12 Questionnaire

    Time frame: 12 months

    Evaluation the Health-Related Quality of Life (HRQoL) as measured by the physical component score (PCS) of the 12-Item Short-Form Health Survey version 2 (SF-12v2®) questionnaire

  3. WOMAC Total Score

    Time frame: 24 months

    Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score

  4. Health Assessment Questionnaire Disability Index

    Time frame: 12 months

    Evaluation of the HRQoL as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI)

Other outcomes

  1. Radiography for Structural Change in Knee Joint

    Time frame: Through 24 months

    Evaluate structural changes of the knee joint as determined by radiography (X-ray)

  2. Efficacy of TG-C with Regard to Knee Function via WOMAC Total Score

    Time frame: At Months 3, 6, 9 and 18

    Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score

  3. Efficacy of TG-C with Regard to Knee Function via WOMAC Pain, Function, and Stiffness Scores

    Time frame: Through 24 months

    Evaluate the efficacy of TG-C with regard to knee function via WOMAC® pain, function, and stiffness scores

  4. Efficacy of TG-C with Regard to Knee Function via VAS Pain Score

    Time frame: At Day 1, Week 1, and Months 1, 3, 6, 9, 18 and 24

    Evaluation of the efficacy of TG-C with regard to knee function via VAS pain score at time points other than Month 12

  5. OMERACT-OARSI Responder Analysis

    Time frame: 12 and 24 months

    Analysis of response using the Outcomes Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-OARSI responder criteria

Sponsors and collaborators

Lead sponsor

Kolon TissueGene, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee

Important dates

Study start
2018
Primary completion
2024
Study completion
2026
First posted
Jun 29, 2017
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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