KNEE OA TRIAL ENROLLS FIRST SUBJECT (Orthopedics This Week)
San Diego-based Cytori Therapeutics, Inc. has treated its first patient in its FDA approved trial assessing the effect of Cytori Cell Therapy for osteoarthritis of the knee. Peter Hanson, M.D., medical director of Orthopedic Surgery at Sharp Grossmont Hospital, took care of the patient.
The trial, called ACT-OA, is a Phase II FDA randomized, double-blind placebo controlled trial involving 90 patients. They will be evaluated on the efficacy and safety of Cytori’s autologous adipose derived therapy called ECCO-50. The trial will test 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 the subjects’ 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.
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 fun...
