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Efficacy & safety of genetically engineered chondrocytes with TGF-β1 vs placebo in knee OA

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Ace Report Cover
May 2016

Efficacy & safety of genetically engineered chondrocytes with TGF-β1 vs placebo in knee OA

Vol: 5| Issue: 5| Number:2| ISSN#: 2564-2537
Study Type:Randomized Trial
OE Level Evidence:2
Journal Level of Evidence:N/A

Preliminary results of a phase II randomized study to determine the efficacy and safety of genetically engineered allogeneic human chondrocytes expressing TGF-β1 in patients with grade 3 chronic degenerative joint disease of the knee

Osteoarthritis Cartilage. 2015 Dec;23(12):2109-18.

Contributing Authors:
JJ Cherian J Parvizi D Bramlet KH Lee DW Romness MA Mont

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Synopsis

102 patients with grade III (Kellgren-Lawrence) knee osteoarthritis were randomized to intra-articular injection administration of either genetically engineered chondrocytes expressing TGF-b1 (GEC-TGF-b1; TissueGene-C; TissueGene Inc.) or placebo. The purpose of this study was to evaluate the efficacy and safety of the GEC-TGF-b1 investigational product. Primary outcomes for function and pain (IKD...

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