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: