Monday, July 20, 1998
Germ-line integration of gene therapy vectors
The National Institute of Health's Recombinant DNA Advisory Committee
reported at a recent meeting that it has received notice of four cases in which sequences
from gene therapy vectors have appeared in the ovaries or testes in animal studies.
FDA had reported at a Dec. 15, 1997 RAC meeting that it observed
unexpected persistence of vector nucleic acid in gonadal tissue in multiple animal
studies, raising the concern that gene vectors could lead to germ-line integration and
pose unknown risks to patients in clinical trials.