San Diego-based Cytori Therapeutics (Nasdaq: CYTX) has received investigational device exemption approval from the Food and Drug Administration 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 10-patient, open-label study in 2014. Following a 90-day assessment of the first 10 patients, Cytori is approved by the FDA to expand Recover to a multidose, multicenter, double-blind, placebo-controlled trial. Recover will evaluate Cytori Cell Therapy in patients with Grade 2 tears of the hamstring muscle.
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.
"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, CEO 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."
Cytori is building a cell therapy sports medicine business. In the U.S., the company is pursuing a clinical development strategy initially with the Recover trial. Internationally, the company is in the process of initiating two multicenter registries for related indications in countries where the Celution System is available for commercial use. The Achilles Registry will collect data from patients with muscle and ligament injuries treated with Cytori Cell Therapy and the Relieve Registry will collect data from patients with osteoarthritis. Both registries will collect patient data and may support future regulatory and reimbursement efforts.