Why the study?
Is gene therapy transferring anti-arthritic genes safe in patients with rheumatoid arthritis?
Is gene therapy transferring anti-arthritic genes safe in patients with rheumatoid arthritis?
This pioneering phase I trial demonstrates the safety of gene therapy in human joints, paving the way for future applications in arthritis and orthopedic conditions.
Phase I safety supports cautious progression to efficacy trials; leaves open durability and clinical benefit in rheumatoid arthritis.
Advances in understanding the biology of rheumatoid arthritis (RA) have opened new therapeutic avenues. One of these, gene therapy, involves the delivery to patients of genes encoding anti-arthritic proteins. This approach has shown efficacy in animal models of RA, and the first human, phase I trial has just been successfully completed. Hand surgery featured prominently in this pioneering study, as a potentially anti-arthritic gene encoding the interleukin-1 receptor antagonist was transferred to the metacarpophalangeal joints of subjects with RA one week before total joint arthroplasty. This study has confirmed that it is possible to transfer genes safely to human joints. It should pave the way for additional application of gene therapy to arthritis and other orthopaedic conditions.
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Gouze et al. (2001) studied this question.
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