| Initial phase I safety of retrovirally transduced human chondrocytes expressing transforming growth factor-beta-1 in degenerative arthritis patients. | |
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MedLine Citation:
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PMID: 22242865 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Abstract Background aims. TissueGene-C (TG-C) represents a cell-mediated gene therapy for localized delivery of allogeneic chondrocytes expressing transforming growth factor (TGF)-β1 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-β1-expressing chondrocytes (hChonJb#7) in order to help fill in the defect and as target cells for the actions of the expressed TGF-β1. 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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Authors:
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Chul-Won Ha; Moon Jong Noh; Kyoung Baek Choi; Kwan Hee Lee |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Cytotherapy Volume: 14 ISSN: 1477-2566 ISO Abbreviation: Cytotherapy Publication Date: 2012 Feb |
Date Detail:
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Created Date: 2012-01-16 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100895309 Medline TA: Cytotherapy Country: England |
Other Details:
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Languages: eng Pagination: 247-56 Citation Subset: IM |
Affiliation:
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Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul , Korea. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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