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Notification report


Full notification file


General information

Notification Number
B/ES/12/37

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
12/09/2012

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?
Yes:
France; United Kingdom;

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

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