Cytori Receives IDE Approval from FDA to Initiate US Clinical Trial of Adipose-Derived Regenerative Cells in Hamstring Injuries

Cytori Therapeutics

has received Investigational Device Exemption (IDE) approval from the FDA to begin a prospective clinical trial to evaluate the safety and feasibility of Cytori Cell Therapy as a potential treatment for hamstring injuries. The trial, referred to as RECOVER, will begin as a ten-patient, open label study in 2014. Following a 90-day assessment of the first ten patients, Cytori is approved by the FDA to expand RECOVER to a multi-dose, multi-center, double-blind, placebo-controlled trial. Cytori Cell Therapy is derived from the Company's Celution® System, which enables access to a patient's own adipose-derived regenerative cells (ADRCs) at the point-of-care.