(NASDAQ:CYTX) 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.
RECOVER will evaluate Cytori Cell Therapy in patients with Grade II tears of the hamstring muscle. RECOVER will initially enroll ten patients in the United States. The first ten patients will be given one of two doses of Cytori Cell Therapy in an open-label manner, with the first five patients receiving the lower dose and the second five patients receiving the higher dose. Once the safety and feasibility of administering Cytori Cell Therapy has been confirmed in the first ten patients (Part A), Cytori has the option to expand RECOVER to include an additional 60-patients in the multi-center, double-blind, placebo-controlled phase of the trial (Part B). The 60 patients would be divided into three groups of 20 patients. Patients in a given group will receive a lower dose, a higher dose or placebo. The study would assess safety and tolerability and evaluate the effect of the cells on how fast the muscle tear heals (ultrasound and MRI), muscle strength, muscle function and pain. The timeline to complete the first phase of the study will be provided once the trial is initiated and Cytori is able to forecast enrollment.
“We have been studying ADRCs in acute and chronic muscle injuries in the heart for more than a decade and Cytori Cell Therapy is thought to play a role in improving perfusion and reducing inflammation in damaged cardiac muscle,” said Christopher J. Calhoun, Chief Executive Officer of Cytori. “Similarly, we believe ADRCs could support healing in injured skeletal muscle such as that of a hamstring injury. Initially, RECOVER involves a minimal, incremental investment for the first ten patients. If successful, RECOVER may provide an accelerated path to market in the U.S. targeting the millions of recreational and professional sports injuries that occur each year.”