Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority.
The San Diego-based company plans to assess the safety and feasibility of intravenous delivery of its cell therapy as an adjunct to standard care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. The Relief trial is slated to enroll up to 30 patients and will start when BARDA exercises a contract option to provide the necessary funds, according to Cytori.