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Notification report


Full notification file


General information

Notification Number
B/DE/12/PEI1713

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
07/09/2012

Title of the Project
A Phase I-II Gene Therapy trial for X-CGD with a SIN gamma retroviral vector

Proposed period of release:
01/01/2013 to 31/12/2015

Name of the Institute(s) or Company(ies)
JW Goethe University, Dept of Internal Medicine II
Hematology/Oncology
Medical School
JW Goethe University
Theodor-Stern-Kai 7 60596 Frankfurt
Germany;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
Other: Animal, mammal, Homo sapiens

Identity of the GMO:
The GMO consists of human CD34+ cells from an X‐CGD patient. The cells are genetically modified with a replication-defective retroviral vector. The cells will be used only for therapeutic purposes in the same patient from whom the cells were obtained (autologous application). Homo sapiens.

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