Cytori Therapeutics says receives FDA approval to expand Scleroderma trial Cytori Therapeutics announced that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. The STAR study is an 80 patient pivotal clinical trial approved by FDA in January to study the effects of Cytori’s lead drug ECCS-50 for treatment of patients with hand manifestations of Scleroderma.
Cytori Therapeutics begins enrollment in Phase II ACT-OA trial Cytori Therapeutics 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. 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.