Search the database for deliberate release of GM medicinal products

Displaying 1 - 9 of 9

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/18/BVW3	A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck	Oragenics, Inc.	Humans	Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018.	A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy	Immune Design	Humans	Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen
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)
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
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 13/10/2000.	A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi	Glaxo Wellcome	Humans	vCP-1452
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 26/03/1998.	Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha	Pasteur Mérieux Connaught	Humans	HLA-A1 restricted CTL epitope of MAGE-1 and MAGE-3 genes
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)