Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
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/12/BVW1
A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy TheraVectys
Humans
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
Only notified under the "contained use" procedure. Dossier submitted on 8 May, 2012
.
A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects ActoGenix
Humans
Human Trefoil Factor 1
Only notified under the "contained use" procedure. Dossier submitted on 23 April, 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
B/BE/09/BVW1
A randomized, double blind, placebo controlled, parallel group, multicenter study of the safety and response rate of 3 subcutaneously administered doses of 5 x 10^7 pfu RO5217790 in patients with high grade cervical intraepithelial neoplasia grade 2 N.V. Roche S.A.
Humans
E6 and E7 genes of the HPV16 virus and gene of the human Interleukin-2 (hIL2)
B/BE/08/BVW1
MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants MedImmune LLC
Humans
Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
