Document Detail

Pre-clinical studies of retrovirally transduced human chondrocytes expressing transforming growth factor-beta-1 (TG-C).
MedLine Citation:
PMID:  20370350     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AIMS: The aim was to evaluate cartilage regeneration in animal models involving induced knee joint damage. Through cell-mediated gene therapy methods, a cell mixture comprising a 3:1 ratio of genetically unmodified human chondrocytes and transforming growth factor beta-1 (TGF-beta1)-secreting human chondrocytes (TG-C), generated via retroviral transduction, resulted in successful cartilage proliferation in damaged regions. METHODS: Non-clinical toxicology assessments for efficacy, biodistribution and local/systemic toxicity of single intra-articular administration of the cell mixture in mice, rabbits and goats was conducted. RESULTS: Administration of the mixture was tolerated well in all of the species. There was evidence of cartilage proliferation in rabbits and goats. As an additional precautionary step, the efficacy of TGF-beta1 secretion in irradiated human chondrocytes was also demonstrated. CONCLUSIONS: Four studies in rabbits and goats demonstrated the safety and efficacy of TG-C following direct intra-articular administration in animal models involving induced knee joint damage. Based on these pre-clinical studies authorization has been received from the USA Food and Drug Administration (FDA) to proceed with an initial phase I clinical study of TG-C for degenerative arthritis.
Moon Jong Noh; R Ogden Copeland; Youngsuk Yi; Kyoung-Baek Choi; Carol Meschter; Sally Hwang; Chae-Lyul Lim; Vivian Yip; Jong-Pil Hyun; Hyeon-Youl Lee; Kwan Hee Lee
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Cytotherapy     Volume:  12     ISSN:  1477-2566     ISO Abbreviation:  Cytotherapy     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-04-07     Completed Date:  2010-07-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100895309     Medline TA:  Cytotherapy     Country:  England    
Other Details:
Languages:  eng     Pagination:  384-93     Citation Subset:  IM    
TissueGene Inc., Rockville, Maryland, USA.
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MeSH Terms
Cartilage / cytology,  pathology,  physiology
Cell Transplantation*
Cells, Cultured
Chondrocytes / cytology,  physiology*
Gene Transfer Techniques
Mice, SCID
Regeneration / physiology
Retroviridae* / genetics,  metabolism
Transduction, Genetic*
Transforming Growth Factor beta1 / genetics,  metabolism*
Reg. No./Substance:
0/Transforming Growth Factor beta1

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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