Adenoviral-based biological delivery and expression system for use in the treatment of osteoarthritis

A process of infecting joint cells of a human or a mammal suffering from osteoarthritis or an osteoarthritic condition with an adenoviral-based biological delivery and expression system comprising the steps of:

• infecting the joint cells of the human or the mammal suffering from the osteoarthritis or the osteoarthritic condition with the adenoviral-based biological delivery and expression system which comprises a helper-dependent adenoviral vector containing a nucleic acid sequence encoding human or mammalian IL-1Ra, left and right inverted terminal repeats, an adenoviral packaging signal and non-viral, non-coding stuffer nucleic acid sequences, wherein the expression of the human or the mammalian IL-1Ra gene is regulated by a one component inflammation-inducible promoter, which is located upstream of a reading frame of the nucleic acid sequence encoding the human or the mammalian IL-1Ra and which is specifically activated by immune stimulatory substances;
• and expressing IL-1Ra in the joint cells, wherein the inflammation-inducible promoter is an NF-kB promoter, and wherein the promoter, the left and the right inverted terminal repeats, the adenoviral packaging signal and the non-viral, non-coding stuffer nucleic acid sequences have at least 90% sequence homology to the nucleic acid sequence of SEQ ID NO:
• 2 or SEQ ID NO:
• 3.

A process of treating osteoarthritis or an osteoarthritic condition in human or mammalian joints or preventing a human or mammal identified to be at risk of developing osteoarthritis or an osteoarthritic condition in human or mammalian joints from developing an osteoarthritis or an osteoarthritic condition, the process comprising administration of an adenoviral-based biological delivery and expression system comprising a helper-dependent adenoviral vector containing a nucleic acid sequence encoding human or mammalian IL-1Ra, left and right inverted terminal repeats, an adenoviral packaging signal and non-viral, non-coding stuffer nucleic acid sequences, wherein the expression of the human or the mammalian IL-1Ra gene is regulated by a one component inflammation-inducible promoter, which is located upstream of a reading frame of the nucleic acid sequence encoding the human or the mammalian IL-1Ra and which is specifically activated by immune stimulatory substances into one or more joints of a subject in need of treatment by intra-articular injection, wherein the inflammation-inducible promoter is an NF-kB promoter, and wherein the promoter, the left and the right inverted terminal repeats, the adenoviral packaging signal and the non-viral, non-coding stuffer nucleic acid sequences have at least 90% sequence homology to the nucleic acid sequence of SEQ ID NO:

• 2 or SEQ ID NO:
• 3.