Full notification file
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 is a:
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
Human Immunodeficiency Virus 1
European Commission administrative information
Consent given by the Member State Competent Authority: