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 of the infusion of autologous CD34+ cells ex vivo transduced with a lentiviral vector carrying the Red-cell type Pyruvate Kinase (RPK) gene for patients with Pyruvate Kinase Decifiency (PKD)

Proposed period of release:
01/03/2018 to 31/12/2021

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?
United Kingdom; Italy; Netherlands;

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

GMO characterization

GMO is a:
Other: Genetically modified autologous CD34+ cells

Identity of the GMO:
Human hematopoietic progenitors CD34+ from Pyruvate Kinase Deficient patients (Homo sapiens sapiens) transduced with self-inactivating (SIN) lentiviral vector PGK-coRPK (CPcoRPKW-17)

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

European Commission administrative information

Consent given by the Member State Competent Authority:
31/10/2017 00:00:00