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Notification report


Full notification file


General information

Notification Number
B/FR/12/GT03

Member State to which the notification was sent
France

Date of acknowledgement from the Member State Competent Authority
18/06/2012

Title of the Project
A phase I/II, Open Labeled, Monocentric Study of Direct Intracranial Administration of a Replication Deficient Adeno-associated Virus Gene Transfer Vector Serotype rh.10 Expressing the Human ARSA cDNA to Children with Metachromatic Leukodystrophy

Proposed period of release:
01/04/2012 to 01/12/2017

Name of the Institute(s) or Company(ies)
Inserm, ;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The GMO, a gene therapy vector, is a non replicative AAVrh.10cuARSA vector. It is a modified single strand AAV2- DNA encapsulated in an AAVrh.10 capsid. The AAVrh10 capsid is derived from an AAV virus isolated in simians.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
AAV2 wt-----
AAVrh.10-----
Gallus gallus-----
Human-----
human Herpes virus-----
Oryctolagus cuniculus-----

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known