By Maureen McArthur

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"Although the first gene therapy clinical protocol was approved by the National Institutes of Health (NIH) in 1989 and 280 protocols have been sent to the NIH for review by February 1999, no widely available recommendations for infection control exist from federal or private organizations."

- Martin Evans, M.D., director, infection control, UK Hospital, and principal organizer of the conference

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See related story in the Oct. 22, 1999, issue of the Lexington Herald-Leader.

"Although the first gene therapy clinical protocol was approved by the National Institutes of Health (NIH) in 1989 and 280 protocols have been sent to the NIH for review by February 1999, no widely available recommendations for infection control exist from federal or private organizations," said Martin Evans, M.D., director, infection control, UK Hospital, and principal organizer of the conference.

Among the experts presenting are physicians and scientists from the UK Chandler Medical Center, the Institute for Human Gene Therapy at the University of Pennsylvania School of Medicine, the Centers for Disease Control and Prevention, and the University of North Carolina at Chapel Hill Hospital and School of Medicine.

Gene therapy aims to treat a disease by modifying the action of a person’s genes. The goal of gene therapy with genetic diseases, which result from defective, or mutated, genes, is to deliver a correct copy of the mutated gene directly to the nucleus of the abnormal cells, thereby restoring normal function of the gene. Many other types of diseases that are not strictly genetic diseases currently are being investigated for gene therapy, including cardiovascular and infectious diseases. In these instances, gene therapy aims to insert genes that control or affect the action of the disease-causing genes.

To insert the corrective gene into the appropriate cells, the gene must be placed in a delivery vehicle, or vector. The corrective gene can be encapsulated in liposomes, small balls made of molecules that resemble cell membranes, or viruses. If viruses are used as the gene-delivery vector, the harmful viral genes and the genes responsible for viral replication are removed.

However, as with all potential infectious agents, questions about the procedures to ensure safety for gene therapy trial participants, health care workers, and other patients and visitors in the clinic or hospital are being brought to the attention of infection control specialists. But no generally applicable answers to these questions currently are available.

"This conference is designed to provide a forum for gene therapy experts to share their perspectives and experiences with infection control practitioners and others who wish to participate in clinical gene therapy protocols, with the goal of providing answers to the procedural questions," Evans said.