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August 12, 2014
11:20 EDTCYTXCytori Therapeutics reports publication of six month data from scleroderma study
Cytori Therapeutics (NASDAQ: CYTX) today announced that six month outcomes from a 12 patient independent investigator-initiated study using Cytori Cell Therapy to treat scleroderma have been published in the Annals of Rheumatic Disease. Data from the study indicated that treatment with Cytori Cell Therapy was safe and well tolerated through six months. In addition, the data indicated an approximately 50% average improvement across four key, validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function at two months, with benefits sustained through six month follow-up. “After six month follow up, we are encouraged by the results that have been seen by the investigators in France...The investigators in Marseille have continued to follow the patients and are considering a larger, controlled study based on these positive outcomes,” said Dr. Steven Kesten, Chief Medical Officer, Cytori.
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February 26, 2015
08:02 EDTCYTXCytori 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.
February 24, 2015
08:17 EDTCYTXCytori Therapeutics receives positive European opinion on orphan drug status
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February 17, 2015
08:03 EDTCYTXCytori 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.

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