NCT00482092.

Study name	Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment‐resistant Moderate‐to‐severe Crohn's Disease Title: A Phase III, Multicenter, Placebo‐controlled, Randomized, Double‐blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment‐refractory Moderate‐to‐severe Crohn's Disease
Methods	Randomised controlled Phase III trial.
Participants	Estimated 330 participants Enrolling subjects with moderate‐to‐severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti‐body to tumor necrosis factor alpha. subjects of 18 Years to 70 Years
Interventions	The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time. Compartor arms: Arm 1: Low dose (600 million cells total over four infusions in two weeks) Arm 2: High dose (1200 million cells delivered in four infusions over two weeks) Control: Placebo
Outcomes	Primary outcome: Disease remission (CDAI at or below 150) [ Time Frame: 28 days ]
Starting date	May 2007
Contact information	Study Director: Pushpam Bharathi Mesoblast International Sarl
Notes	estimated study completion time: July 2020 Sponsors and Collaborators: Mesoblast International Sàrl