Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TxCell

Criteria

Main Inclusion Criteria:

1. Active Crohn's Disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation:

• Documented endoscopic evidence of inflammatory bowel disease (IBD), compatible with Crohn's diagnosis at least 1 year prior to screening and

• High sensitive C-reactive protein (hs-CRP) > 10 mg/L at V1.

2. Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologics; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for CD

3. Documented CDAI (Crohn's Disease Activity Index) above 250 points (CDAI ≥ 250) at screening or within the past 3 months;