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/25/BVW5 | GenePHIT: A study to learn more about how well a new gene therapy (AB-1002) works and its safety in participants with congestive heart failure | Asklepios BioPharmaceutical (AskBio) | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV2i8 carrying the transgene encoding for the human activated Inhibitor-1c ( I-1c) |
| Only notified under the "contained use" procedure. Dossier submitted on . | 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) |