TiGenix, a European cell therapy company, has completed patient enrolment in a Phase IIa rheumatoid arthritis (RA) study of Cx611.
Cx611 is a suspension of expanded allogeneic adult stem cells derived from human adipose tissue, delivered through intravenous injection for the treatment of RA.
TiGenix CEO Eduardo Bravo said that, in addition to the primary endpoints of safety and optimal dosing, the company expects the trial to indicate the period of effectiveness of Cx611 in patients who have failed to respond previous treatments.
"In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result," Bravo said.
"This is the most advanced stem cell therapy trial in RA in the world, and completing the enrollment on time confirms our leadership position in the field."
The Phase IIa multicentre, placebo-controlled trial has enrolled 53 patients. They will be divided into three groups with different dosing regimens.
The objective of the Phase IIa RA study is to determine safety, feasibility, tolerance, and optimal dosing.
The study is being conducted at 23 centres and the company expects the final results to be available in the first half of 2013.