PRESS RELEASE - XCell-Center GmbH gets approval by French Health Authorities to conduct Clinical Trial with Stem Cells for Chronic Spinal Cord Injury
June 1, 2010
(Dusseldorf, Germany) June 1, 2010 - XCell-Center GmbH, Europe's leading provider of adult autologous stem cell therapy, announced approval of the first placebo controlled double-blind clinical trial in patients with chronic spinal cord injury.
L'Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), (the French equivalent to the United States Food and Drug Administration) has authorized this multi-centre, phase II/ III clinical study to assess the efficacy and safety of autologous adult stem cell therapy in patients suffering from chronic traumatic spinal cord injury. The clinical trial has also been approved by the Ethics committee and will evaluate 120 patients. The Stem Cells will be processed at XCell-Center's cGMP certified laboratory in Germany, using its proprietary cell processing technology (patent pending).
Principal Investigator of the Study is Prof Jean Chazal from the University Hospital in Clermont-Ferrand, France.
Prof. Erik Wolters from the Free University Hospital of Amsterdam, The Netherlands, is the Chairman of the Clinical Trial Steering Committee.
According to Dr. C. Kleinbloesem, CEO XCell-Center GmbH, "We are ready to begin the clinical trial that will mark the beginning of new era to help patients with spinal cord injuries".
To learn more about XCell-Center and review safety data, please visit:
/media/89867/safety%20database%20lp%20febr2010.pdf
XCell-Center
XCell-Center GmbH
at the Institute for Regenerative Medicine
Am Heerdter Krankenhaus
2
40549 Dusseldorf, Germamy
E-Mail: info@xcell-center.de
Phone: 1-866-680-8202 (USA Toll-Free) (+49) 0221-802-5095 (Germany) Fax: 1-713-583-9322 (USA) (+49) 0221-2921-2550 (Germany)
