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Notification report


Full notification file


General information

Notification Number
B/ES/17/17

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
07/09/2017

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?
Yes:
United Kingdom; Italy; Netherlands;

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known