Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A randomized double-blind placebo-controlled parallel group study of the efficacy and safety of 4 administrations of XRP0038/NV1FGF 4mg at 2-weeks intervals on amputation or any death in Critical Limb Ischemia patients with skin lesions

Proposed period of release:
01/05/2008 to 30/12/2011

Name of the Institute(s) or Company(ies)
Erasmus MC, Erasmus MC
s-Gravendijkwal 230
Afdeling Urologie
Rotterdam 3015 CE
The Netherlands;

3. Is the same GMO release planned elsewhere in the Community?
Austria; Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Italy; Netherlands; Sweden; Czech Republic; Hungary; Poland;

Has the same GMO been notified elsewhere by the same notifier?

GMO characterization

GMO is a:
Other: recombinant DNA plasmid

Identity of the GMO:
XRP0038 / NV1FGF is a recombinant DNA plasmid, constructed by inserting a gene encoding fibroblast growth factor type 1 (FGF1) into a pCOR plasmid backbone.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Escherichia ColiEscherichia Coli

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known