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Results of world's first gene therapy trial for arthritis show approach safe, feasible

en that gene therapy was so new and we were dealing with an otherwise healthy patient population, the ex vivo protocol was the most appropriate approach to take at the time," stated Paul Robbins, Ph.D., professor of molecular genetics and biochemistry and orthopaedic surgery at the University of Pittsburgh School of Medicine, who was the study's co-principal investigator and then director of the University of Pittsburgh's Viral Vector Core Facility.

According to their results, joints treated with the genetically modified cells exhibited high levels of IL-1 Ra, indicating successful gene transfer. Clusters of cells that expressed large amounts of the gene were present at the surface of the synovial tissue and produced significantly less of the inflammation-provoking IL-6 and PGE 2 than cells within joints that were not treated with the gene.

The nine women enrolled in the trial were between 49 and 73 years of age and had been living with rheumatoid arthritis for between 10 and 26 years. Each was scheduled for joint replacement surgery involving the four knuckles on one of their hands and one additional joint. In the weeks prior to joint replacement surgery, synovial tissue was removed from the additional joint that required surgery. Cells from the tissue were then cultured for several weeks, after which time half the cells had the IL-1 Ra gene inserted and half remained untreated. Six to seven weeks later, following extensive laboratory screening of the genetically modified cells, patients returned to the clinic, where the cells were injected into four knuckles in a double-blind fashion, with two knuckles receiving the gene-modified cells, and two knuckles receiving injections of cells with no added gene. One week later, at the time of the patient's previously scheduled surgery, the four knuckles were removed for study and replaced with artificial joints.

In their animal studies that preceded the clinical trial, the researchers had noted that
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Source:Brigham and Women's Hospital


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