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news.TissueGene has commenced patient recruitment in a randomized, multi-centered, double-blind, placebo-controlled Phase II study to investigate the safety and efficacy of TG-C in patients suffering from chronic degenerative joint disease (DJD) of the knee.
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TissueGene expects to recruit around 100 patients in the trial across US.
In the Phase II trial, the patients will be given intra-articular injection of either TG-C or placebo to the damaged joint area with primary and secondary endpoints involving evidence of symptomatic improvement and cartilage regeneration, respectively.
TissueGene’s licensing partner Kolon Life Science expects to execute TG-C Phase IIb trial in Korea by Q3 2011, having previously received regulatory allowance by the Korean FDA to proceed.
TissueGene chief medical officer Kwan Hee Lee said they believe that TG-C has the potential to become the first noninvasive treatment for osteoarthritis by regenerating cartilage through a simple injection into the knee.