KOLON TISSUEGENE - Knee Osteoarthritis Study

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 2 or 3 Osteoarthritis of the Knee

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WEBSITE LINK for patient

STUDY PROTOCOL can be found here

STUDY PRODUCT: TG-C (Tissue Gene-C (3:1 mixture of non-transduced allogeneic human chondrocytes and irradiated transduced allogeneic human GP2-293 cells expressing TGF-β1)

TREATMENT GROUP:

  • ACTIVE GROUP (TG-C): 340 subjects will receive a single injection of TG-C at a dose of 3.0 × 107 cells.

  • PLACEBO: 170 subjects will receive a single injection of normal saline.

  • RANDOMINZATION: 2:1 (active drug vs. placebo) after stratification by KLG (2 vs. 3) and by gender

DOSAGE & ADMINISTRATION: Single intra-articular injection to the damaged joint area via ultrasound guidance

STUDY DURATION:

  • 48 months (including start-up, enrollment/treatment, follow-up, and close-out)

  • Annual cancer surveillance questionnaires through 15 years post dosing for subjects who do not consent to participate in the separate 15-year Long-Term Safety Study.

PRIMARY OBJECTIVE: Evaluate the efficacy of TG-C with regard to knee function via WOMAC® total score and VAS pain score at 12 months

BLINDING: Everyone is blinded except for medication preparer and the injector

STUDY SCHEDULE:

Schedule chart displaying various assessments and their timing across multiple visit points, from screening and baseline to month 24 and withdrawal, including tests like physical exam, vital signs, radiography, MRI, blood tests, urinalysis, pregnancy test, and biomarker analysis.
A detailed study timeline table showing assessments and sample collections at various visit points from screening to month 24 and withdrawal. Includes biomarkers, pain measures, questionnaires, and medication tracking.

QUICK REFERENCE:

1. Kellgren and Lawrence grading system (Quiz/Answers)

X-ray images of knees showing different cartilage grades from Grade 1 to Grade 4, accompanied by a classification table explaining osteoarthritis severity levels from normal to severe.

2. JSN Grades

3. RCR Testing

4. Section 7.2 (protocol on contraception requirement

A document outlining contraception requirements, including criteria for non-childbearing potential women, male condom use, hormonal and nonhormonal methods, and complete abstinence, for study participation.

5. Section 5.4 - Prohibited Medications / Drug Washout

A section of a formal document titled "Prohibited Medications" listing medications subjects must abstain from, including NSAIDs and steroids, with detailed instructions and notes on washout procedures and restrictions after study drug administration.