Potential North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury: A Consortium of Military, Veterans Administration, and Civilian Hospitals; Annual rept. 14 May 2007-13 Apr 2008

摘要

The first military (WRAMC) and four new civilian hospitals have joined NACTN. 198 patients were enrolled in national data registry; NACTN PIs are analyzing the data and preparing a manuscript on the occurrence of acute injury complications. NACTN has received ORP approval for the data registry protocol and the NACTN Data Management Center has expanded to accommodate increasing patient numbers. Modifications submitted to TATRC include: Stemnion (approved and project underway); FY 2007 and riluzole mods (the latter to replace the originally proposed anti-Nogo study) are in the review/contracting continuum. In anticipation of approval, all NACTN personnel met in February 2008 to discuss the riluzole protocol/safety study, and the centers are working with local IRBs and ORP to fulfill all regulatory requirements for the data registry. The final riluzole protocol will be submitted to the ORP HRPO for HSRRB review after securing IRB approval from one NACTN site. National ASIA training for all clinical NACTN personnel will be held in Louisville June 2-3, 2008. NACTN is collaborating with three other clinical networks: the European Union Clinical Trial Network, the Canadian SCI Translational Research Network and NIH-funded NETT. GRASSP validation is nearing successful completion and preliminary STASCIS data suggest that early decompression of the spinal cord.