Cytori Begins Enrollment in ACT-OA: US Phase II Trial for Knee Osteoarthritis
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced that the first patient has been treated in its FDA approved trial assessing the effect of Cytori Cell Therapy for osteoarthritis of the knee. The patient was treated by Dr. Peter Hanson, Medical Director of Orthopedic Surgery at Sharp Grossmont Hospital.
“Joint disease from osteoarthritis is pervasive, debilitating and significantly impacts quality of life,” said Dr. Hanson. “The ACT-OA trial of Cytori’s new cellular therapeutic, if successful, will fill an important gap in our clinical armamentarium between anti-inflammatory medications and joint replacement. As a surgeon who specializes in total joint replacements of the hips and knees, I have been searching for a biologic solution in order to treat my patients with something other than major surgery.”
ACT-OA is a Phase II FDA approved randomized, double-blind, placebo controlled trial in 90 patients evaluating the efficacy and safety of Cytori’s autologous adipose derived therapy ECCO-50 (Cytori’s therapeutic under study). The trial tests both a low dose and a high dose vs. placebo and will be conducted over 48 weeks. The randomization will be 1:1:1 between the control, low dose and high dose groups. The primary end point will be pain on walking as measured by the Knee Injury and Osteoarthritis Outcome Score at 12 weeks. Secondary endpoints assessed will include pain, joint function, magnetic resonance imaging and adverse events.
“We are enthusiastic about this new therapeutic in light of a substantial amount of preclinical, veterinary and clinical feasibility work that has been conducted thus far,” said Dr. Brian Cole, a Principal Investigator of the ACT-OA trial, and Professor, Department of Orthopedics, Department of Anatomy and Cell Biology, Section Head, Cartilage Restoration Center at Rush, Rush University Medical Center said. “The clinical trial is well designed and I believe it has a good chance of enrolling relatively quickly given the common nature of the disease.”
Osteoarthritis is a disease of the entire joint involving the cartilage, joint lining, ligaments, and underlying bone. The breakdown of tissue leads to pain, joint stiffness and reduced function. It is the most common form of arthritis and affects an estimated 26.9 million US adults.1 Current treatments include physical therapy, non-steroidal anti-inflammatory medications, viscosupplement injections, and total knee replacement. The American Academy of Orthopedic Surgeon’s guidelines for the treatment of osteoarthritis of the knee noted that there were few non-surgical treatments that could be recommended2, which highlights the potential for Cytori Cell Therapy to address a large inadequately addressed medical need.
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell TherapyTM acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell TherapyTM may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
1http://www.cdc.gov/arthritis/basics/osteoarthritis.htm (accessed 2 Feb 2015)
2American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee: evidence-based guideline 2nd edition. http://www.aaos.org/research/guidelines/treatmentofosteoarthritisofthekneeguideline.pdf (accessed 2 Feb 2015)
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