The administration of adenoviral FGF-4 to stented coronary arteries in pigs

A common treatment for arteriosclerosis is the placing of a stent (gauze tube) in the blood vessel to keep it open. However, the placing of the stent promotes a considerable growth of smooth muscle cells, which can result in the stent becoming ineffective. To further investigate this treatment, pigs are being implanted with a stent and injected with an adenoviral vector into which a gene involved in blood vessel formation (HIF-1a) had been cloned. COGEM was asked to provide advice because the applicant had requested permission to return the pigs to a lower containment level, three days after the administration of the adenoviral vector. COGEM is of the opinion that the virus batch used can be regarded as safe and that the risk of replication-competent adenoviral vectors being formed is negligible. On basis of the shedding experiments performed, COGEM considers the risk of shedding three days after the administration of the adenoviral vector, to be negligible. Therefore, COGEM is of the opinion that the pigs can be returned to level 1 animal accommodation, three days after the administration of the vector.