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 |
Humans |
Modified cells expressing Hemoglobin F (HbF) |
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. |
A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers |
Humans |
Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN) |
Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018. |
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. |
Humans |
human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4) |
B/BE/04/BV1 |
Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats |
cats |
gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV) |