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Full notification Final report - General information Notification Number B/ES/22/10 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 16/05/2022 Title of the Project Phase II clinical trial of autologous hematopoietic stem cell gene therapy for the treatment of severe combined immunodeficiency due to RAG1 gene deficiency. “PHASE I/II CLINICAL TRIAL OF AUTOLOGOUS HEMATOPOIETIC STEM CELL GENE THERAPY FOR RAG1-DEFICIENT SEVERE COMBINED IMMUNODEFICIENCY” (EudraCT: 2019-002343-14). Proposed period of release: 01/01/1970 to 01/01/1970 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
Is the same GMO been notified elsewhere by the same notifier? Yes:
Austria; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Ireland; Iceland; Italy; Luxembourg; Norway; Portugal; Sweden;
Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/NL/18/014; GMO characterization GMO is a: Other Identity of the GMO: Autologous CD34+ human hematopoietic stem cell transduced with HIV-1-derived lentiviral vector self-inactivating non-replicative (SIN) to transcribe and translate the RAG1 gene into the correct protein in the nucleus of the transduced cells.  Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Human Genus: Homo Species: Homo Sapiens Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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