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 Francaise de Securite Sanitaire des Produits de Sante (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."
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