Search the database for deliberate release of GM medicinal products

Displaying 1 - 6 of 6
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/21/BVW2 Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects Wageningen Bioveterinary Research (Larissa Consortium) Humans hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments.
MB-CART2019.1 A phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or resistant B-NHL Miltenyi Biotech GmbH Humans CD19 and CD20 chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018. A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease CRISPR Therapeutic AG Humans Modified cells expressing Hemoglobin F (HbF)
Only notified under the "contained use" procedure. Dossier submitted on 23/04/2012. Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia Molmed S.p.A. Humans -Thymidine Kinase (HSV-Tk) - selection marker
Only notified under the "contained use" procedure. Dossier submitted on 09/06/1998. A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous Rhone-Poulenc Rorer Humans Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 24/10/1996. Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of Genetic therapy, Inc., Sandoz Pharma, Ltd Humans Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)