Ortec completes enrollment in OrCel trial to heal venous leg ulcers

By Elaine Rigoli

Tampa, Fla., April 25 - Ortec International, Inc. has completed patient enrollment of a trial designed to confirm the superiority of cryopreserved OrCel in the healing of difficult-to-heal venous leg ulcers in comparison to standard therapy.

Trial data will be analyzed upon completion of the 12-week treatment phase for the last patient enrolled, according to a news release.

The primary efficacy endpoint is investigator assessment of 100% wound closure within 12 weeks, the release said.

As described in its clinical trial protocol approved by the Food and Drug Administration, the primary endpoint efficacy data of the 61 patients enrolled in this trial will be integrated with results of 61 patients from the company's earlier pivotal trial.

The trial is being conducted at 10 clinical sites located throughout the United States. As previously announced, the confirmatory trial is being conducted at the recommendation of the FDA to confirm Ortec's pivotal trial results.

Ortec is focused on advancing regenerative medicine and stem-cell therapy and is based in New York.

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