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Notification report


Full notification file


General information

Notification Number
B/NL/18/014

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
07/06/2019

Title of the Project
RAG1-SCID CD34+ gene therapy and RAG2-SCID CD34+ gene therapy using 3rd generation self-inactivating (SIN)-lentiviral vector.

Proposed period of release:
01/08/2019 to 01/08/2049

Name of the Institute(s) or Company(ies)
Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Ireland; Italy; Luxembourg; Portugal; Sweden; Iceland; Norway;

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

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Autologous CD34+ cells transduced with a replication-deficient HIV-1 derived viral vector to transcribe and translate a correct form of the RAG1 or RAG2 protein in the nucleus of the transduced cells.

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:
Yes
16/08/2019 00:00:00
Remarks: