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

NCT02327221 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-04-25

No results posted yet for this study

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.

Conditions

  • Crohn Disease

Interventions

DRUG

Ovasave

During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.

DRUG

Placebo

During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.

Sponsors & Collaborators

  • TxCell

    lead INDUSTRY

Principal Investigators

  • Severine VERMEIRE, MD · UZ Gasthuisberg, Gent (Belgium)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02327221 on ClinicalTrials.gov