期刊
CYTOTHERAPY
卷 14, 期 2, 页码 247-256出版社
INFORMA HEALTHCARE
DOI: 10.3109/14653249.2011.629645
关键词
cell-mediated therapy; degenerative arthritis; phase I clinical study; transforming growth factor-beta-1
类别
资金
- Korean Government [02-PJ2-PG4-PT01-0001, 10024054]
- Korea Institute of Industrial Technology(KITECH) [10024054] Funding Source: Korea Institute of Science & Technology Information (KISTI), National Science & Technology Information Service (NTIS)
Background aims. TissueGene-C (TG-C) represents a cell-mediated gene therapy for localized delivery of allogeneic chondrocytes expressing transforming growth factor (TGF)-beta 1 directly to the damaged knee joint. Untransduced human chondrocytes (hChonJ cells) have also been incorporated into the TG-C product at a 3:1 ratio with TGF-beta 1-expressing chondrocytes (hChonJb##7) in order to help fill in the defect and as target cells for the actions of the expressed TGF-beta 1. Methods. A phase I dose-escalating clinical trial was performed to evaluate the safety and biologic activity of TG-C in patients with advanced osteoarthritis 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, patients were monitored for safety, and an evaluation was performed to assess the pharmacokinetics and biologic activity of TG-C. Results. There were no treatment-related serious adverse events. Swelling, 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, patient numbers were not sufficient to determine statistical significance. Conclusions. Overall, there were no significant safety issues related to the administration of TG-C, with only some minor injection site reactions observed. Additionally, knee scoring analyzes indicated a possibility that TG-C may contribute to improvement of arthritic symptoms. More study is warranted to evaluate further the safety and determine the potential efficacy of TG-C.
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