Cytomedix, Inc. announced the completed enrollment of the RECOVER-Stroke trial. Based on an interim resizing analysis that was performed on the existing population of all subjects who have reached the treatment plus 90 days primary efficacy endpoint, it was concluded that the ongoing RECOVER-Stroke trial is adequately powered based on pre-specified assumptions at the current enrollment of 48 patients. Consequently, additional screening and enrollment of new patient subjects will cease immediately.

The company expects to announce the top line clinical results in May 2014 when they become available. The RECOVER-Stroke trial is a double-blind, multi-center, placebo-controlled trial designed to assess the safety and efficacy of ALD-401 in patients with unilateral, cerebral ischemic stroke. The company, in regular review of blinded data, noted that the pooled standard deviation of the primary efficacy endpoint measurement was substantially lower than assumed in the initial power analysis.

Following the company's review with its expert advisors, a formal, blinded interim resizing was performed. This analysis determined that the trial is approximately 90% powered to demonstrate the clinically appropriate difference in the primary efficacy endpoint, if any such difference exists. Importantly, there were no changes made to the assumed treatment effect variable in the resizing calculation and, therefore, no inferences about clinical efficacy can or should be made from this analysis before the May 2014 expected top line clinical result data availability.