Adipose-derived stem and regenerative cells: Phase II action

Cytori said FDA will allow the biotech to resume enrollment in the double-blind, placebo-controlled, U.S. Phase II ATHENA and ATHENA II trials evaluating ADRCs. The company said it had submitted data and protocol amendments to FDA to support the restart of enrollment after halting the trials in August after observing cerebrovascular events in 3 patients (see BioCentury, Aug. 11). Cytori said it is "assessing what the delay means" for the trials and will provide an updated plan on its quarterly investor call, which is slated for Nov. 6. ...