XCell-Center GmbH Gets Approval by French Health Authorities to Conduct Clinical Trial with Stem Cells for Chronic Spinal Cord Injury
By Xcell-center, PRNESunday, June 6, 2010
DUSSELDORF, Germany, June 7, 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 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."
To learn more about XCell-Center and review safety data, please visit:
www.xcell-center.com/media/89867/safety%20database%20lp%20febr2010.pdf
XCell-Center
www.xcell-center.com
XCell-Center GmbH at the Institute for Regenerative Medicine, USA Toll-Free, +1-866-680-8202, or Germany, (+49)-0221-802-5095, or Fax, USA, +1-713-583-9322 , Germany, (+49)0221-2921-2550, info at xcell-center.de
Tags: Dusseldorf, Europe, Germany, June 7, Xcell-center