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March 24, 2014
08:04 EDTCYTXCytori says study using therapy to treat ACL injury underway in Spain
Cytori Therapeutics announces the first investigator-initiated study evaluating Cytori Cell Therapy as a potential concomitant treatment for Anterior-cruciate ligament injury. The study is led by Ramon Cugat, M.D. PhD. Dr. Cugat is President of the Medical Council for the Catalan Soccer Delegation's Health Insurance Company under the Spanish Soccer Federation, President of the Board of Directors of the Council of the Garcia Cugat Foundation for Regenerative Medicine Research, Professor of the Chair of the Garcia Cugat Foundation at CEU Cardenal Herrera University, Director of the Orthopaedic Surgical Department in Hospital Quiron, Barcelona, Spain and Head of Trauma and Orthopaedic Surgery in Mutua Patronal Montaņesa. The study is an investigator-initiated study to determine the feasibility of using Cytori Cell Therapy on patients undergoing complete ACL reconstruction. The study is approved to treat 20 patients who will be followed by both clinical and imaging end points. Thirteen patients have been treated thus far, full enrollment is expected this year and data is being evaluated on a rolling basis. The study was initiated in 2013 under an approval from the Spain Ministry of Health, Social Services and Equality. It was organized by a multidisciplinary team of researchers at Hospital Quiron.
News For CYTX From The Last 14 Days
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February 3, 2016
07:15 EDTCYTXCytori says Cytori Cell Therapy 'safe' and 'effective' in EU Phase 1 ED trial
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January 25, 2016
07:02 EDTCYTXCytori Therapeutics says Phase 3 STAR trial treats 20th patient
Cytori Therapeutics announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 20th patient -- 25% of target enrollment. In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 10 patients and recommended that the study continue as planned. The 20 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully and well tolerated. STAR is a randomized, placebo-controlled, double-blind, parallel group phase III FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving Cytori Cell Therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. The trial began enrollment in August 2015 with enrollment expected to be completed by mid-2016. The STAR trial follows the twelve patient SCLERADEC-I pilot trial in which one year post-treatment results were published in the August 2015 edition of the journal Rheumatology. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud's Phenomena through one-year post-treatment.

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