Search the database for deliberate release of GM medicinal products
Displaying 1 - 3 of 3
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/26/BVW3 | A phase I/II/III study with a dose determination part followed by an efficacy and safety evaluation, quadruple blind placebo-controlled part and then by a long-term safety follow up part, in ambulant boys with Duchenne Muscular Dystrophy | GENETHON | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV, lacking all AAV viral genes and carrying the human dystrophin (hMD1) gene |
| B/BE/18/BVW5 | A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus | Intrexon T1D Partners, LLC | Humans | Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin |
| Only notified under the "contained use" procedure. Dossier submitted on . | Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. | GenSight Biologics | Humans | human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4) |