Cytori Therapeutics (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.”
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 multi-center 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.About Hamstring Injury Hamstring injuries are a persistent problem among elite and amateur athletes given the high incidence and recurrence rates, as well as the lengthy recovery time. According to the Journal of Orthopaedic & Sports Physical Therapy, nearly one third of hamstring injuries recur within the first year following a return to sport, with subsequent injuries often being more severe than the original. About Cytori Cell Therapy and ADRCs Cytori Cell Therapy is a proprietary formulation of a patient’s own regenerative cells derived from their own adipose (fat) tissue that is delivered in the same surgical procedure using the Company’s Celution® System. Adipose tissue is the richest source of stem and regenerative cells in the body. This mixed population of cells, collectively referred to as ADRCs, is accessible at the point-of-care through the Celution® System for use in the same patient, creating new treatment opportunities for currently unmet medical needs. ADRCs collectively contribute to the healing process via cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response. About Cytori Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs improve blood flow, moderate the inflammatory response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution System product family. www.cytori.com Cautionary Statement Regarding Forward-Looking Statements This press release includes forward-looking statements regarding future events and expectations, including but not limited to our belief that Cytori Cell Therapy could support healing in injured skeletal muscles, the potential for RECOVER trial data to accelerate market access and the potential impact of registry data on future regulatory or reimbursement efforts. These forward looking statements involve risks and uncertainties, including the Company’s ability to manage a multi-center clinical trial, regulatory uncertainties, the performance of our products in skeletal muscles, dependence on third party performance, as well as other factors which may be beyond the Company’s control. For additional disclosure regarding these and other risks faced by Cytori Therapeutics, we refer the reader to carefully review the section titled "Risk Factors" in Cytori's filings with the SEC, including its annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Cytori assumes no responsibility to update any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.