Search the database for deliberate release of GM medicinal products
| 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 |
| Only notified under the "contained use" procedure. Dossier submitted on
. |
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
. |
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) |
