Search the database for deliberate release of GM medicinal products

Displaying 1 - 5 of 5
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/19/BVW2 A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels Receiving Prophylactic FVIII BioMarin Pharmaceutical Inc. Humans Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) gene
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant Sangamo therapeutics Humans chimeric antigen receptor specific to the donor HLA A*2
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers Bavarian Nordic A/S Humans Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN)
B/BE/12/BVW2 Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure Celladon Humans Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle
B/BE/04/BV1 Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats Pfizer, Animal Health Group cats gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV)