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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.
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07:05 EDTCYTXCytori Therapeutics begins enrollment in Phase III Adresu trial
Cytori Therapeutics announced that the first patient has been enrolled and treated in the ADRESU trial, a late phase, physician-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell Therapy in men with urinary incontinence after prostatic surgery for prostate cancer or benign prostatic hypertrophy. ADRESU is a multicenter, 45 patient open label controlled trial of the ECCI-50 cellular therapeutic and is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.gov and the MHLW website. The primary endpoint for the ADRESU trial will be the number of patients who experience reduction of urinary leakage volume 52 weeks after treatment. If the endpoint is successfully achieved, the data will be used to seek approval of Cytori Cell Therapy for this indication. The trial costs are substantially supported by Japan's Ministry of Health, Labour and Welfare, with additional support by Cytori. The trial is sponsored by Nagoya University. The ADRESU trial was based on preliminary safety and efficacy data published in 2014 in the International Journal of Urology. Following enrollment and assessment of the results of the trial, Cytori and Nagoya University intend to file for medical device approval for the therapy, which in Japan is typically combined with reimbursement.

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