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
Clinical Trial Phase I / II study to evaluate the safety and efficacy of the infusion of autologous CD34+ cells mobilized with Filgrastim and Mozobil and transduced with a lentiviral vector carrying the FANCA gene (Orphan drug) for patients with Fanconi anemia subtype A

Proposed period of release:
01/06/2013 to 30/06/2016

Name of the Institute(s) or Company(ies)
Centro de Investigaciones Energéticas Medioambientales y Tecnológicas (CIEMAT), ;

3. Is the same GMO release planned elsewhere in the Community?
France; United Kingdom;

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

GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
The GMO is the LV- hPGK FANCA-WPRE* that will be used to transduce CD34+ cells from patients with Fanconi anemia subtype A.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HIV-1RetrovirusHuman Immunodeficiency Virus 1---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known