BACKGROUND AIMS. @entity8265 ( @entity8265 ) represents a cell-mediated gene therapy for localized delivery of allogeneic chondrocytes expressing transforming growth factor (TGF)-b1 directly to the damaged knee joint. Untransduced @entity1 chondrocytes (hChonJ cells) have also been incorporated into the @entity8265 product at a 3:1 ratio with @entity2533 -expressing chondrocytes (hChonJb#7) in order to help fill in the defect and as target cells for the actions of the expressed @entity2533 . METHODS: A phase I dose-escalating clinical trial was performed to evaluate the safety and biologic activity of @entity8265 in @entity1 with advanced @entity571 of the knee joint (full thickness cartilage defect) that was refractory to existing non-operative therapies. Following a single intra-articular injection into the joint space of the damaged knee, @entity1 were monitored for safety, and an evaluation was performed to assess the pharmacokinetics and biologic activity of @entity8265 . RESULTS: There were no treatment-related serious adverse events. @entity4 , effusion and minor localized reactions such as warming sensation or itching were observed in a dose-dependent manner at the injection site. Knee evaluation scores seemed to indicate a dose-dependent trend toward efficacy; however, @entity1 numbers were not sufficient to determine statistical significance. CONCLUSIONS: Overall, there were no significant safety issues related to the administration of @entity8265 , with only some minor injection site reactions observed. Additionally, knee scoring analyzes indicated a possibility that @entity8265 may contribute to improvement of arthritic symptoms. More study is warranted to evaluate further the safety and determine the potential efficacy of @entity8265 .

Initial phase I safety of retrovirally transduced XXXX chondrocytes expressing @entity2533 in degenerative arthritis @entity1 .

@entity1 :: ('9606', 'Species') :: ['human', 'patients', 'patient'] @entity571 :: ('MESH:D010003', 'Disease') :: ['osteoarthritis'] @entity4 :: ('MESH:D004487', 'Disease') :: ['Swelling'] @entity2533 :: ('7040', 'Gene') :: ['TGF-b1'] @entity8265 :: ('7052', 'Gene') :: ['TissueGene-C', 'TG-C']
@entity1 :: (9606,Species) :: ['human']
