In utero injection of cationic liposome-DNA complexes (CLDCs) containing ch
loramphenicol acetyltransferase, beta-galactosidase (beta-gal), or human gr
anulocyte colony-stimulating factor (hG-CSF) expression plasmids produced h
igh-level gene expression in fetal rats. Tissues adjacent to the injection
site exhibited the highest levels of gene expression. Chloramphenicol acety
ltransferase expression persisted for at least 14 days and was reexpressed
following postnatal reinjection of CLDCs. Intraperitoneal administration of
the hG-CSF gene produced high serum hG-CSF levels. X-gal staining demonstr
ated widespread beta-gal expression in multiple fetal tissues and cell type
s. No toxic or inflammatory responses were observed, nor was there evidence
of fetal-maternal or maternal-fetal gene transfer, suggesting that CLDCs m
ay provide a useful alternative to viral vectors for in utero gene transfer
.