FDA OKs IDE For Pilot Trial To Evaluate Cytori Cell Therapy For Thermal Burns

(RTTNews) - Cytori Therapeutics Inc. (CYTX) said Monday that the U.S. FDA has approved an Investigational Device Exemption or IDE for a pilot clinical trial to evaluate Cytori Cell Therapy in patients with thermal burn injury.

This trial, named the RELIEF trial, is a continuation of Cytori's ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority or BARDA, a unit of the U.S. Department of Health and Human Services.

The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area.

Cellular therapeutics such as those offered by the company may have the potential not only to improve the quality and rate of wound healing and reduce scarring but also to be deployable in a cost effective manner, even in mass casualty situations, Cytori said.