The objective of the Phase IIa multicentre, placebo-controlled trial, which has enrolled 53- patients, divided in 3 cohorts with different dosing regimens, 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.
TiGenix CEO Eduardo Bravo said in addition to the primary endpoints of safety and optimal dosing, the company expect the trial to yield a first indication of the duration of the efficacy of Cx611 in the enrolled patients have previously failed to respond to at least two biological.
"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 added.
"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."