- Synovial tissue is removed from thumb joint of patient who will later undergo gene
therapy.
- Synovial cells are recovered from the tissue and cultured for approximately one
week.
- The synovial cell culture is split in half. One part of the culture is exposed to a
retrovirus that contains the gene for the interleukin-1 receptor antagonist (IL-1Ra) protein.
Another part of the culture serves as a control and is not exposed to the gene-containing
virus. This process takes about two weeks.
- Cells exposed to the virus are tested to confirm expression of the therapeutic gene.
Cells from both cultures are then removed and shipped to a FDA-approved facility for
safety testing over the course of six to seven weeks. Meanwhile, the remaining cultured
cells are frozen.
- Safety-tested cells are thawed and prepared for injection into the patient's arthritic
knuckle joints on one hand. Two knuckles are injected with gene-containing synovial cells.
Two knuckles are injected with the control synovial cells.
- One week later, the patient's four arthritic knuckle joints are removed and
replaced with artificial joints, as would normally occur.
- Tissue and fluid from the removed arthritic knuckle joints are analyzed to
determine whether inflammation is reduced in the knuckle joints that received the IL-1Ra
gene. Investigators also determine whether the IL-1Ra protein is made by the new gene
and, if so, whether it has reduced production of other substances in the knuckle joint that
are known to cause inflammation
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