Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease
Status:
Terminated
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of
an autologous antigen-specific regulatory type 1 T lymphocyte expanded population
administered via the intravenous route as an infusion.
The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and
multi-injection study; followed with a 16-week phase with either the possibility for an
open-label treatment part or a safety follow-up part with no injection.
Then, the patients will be followed in an additional long-term safety follow-up, of maximum
duration of 3 years from the first administration.