NSI-566, was approved by the FDA to commence a Phase I trial to treat chronic spinal cord injury (cSI). This open-label, multi-site study will enroll up to eight patients with thoracic spinal cord injuries (T2-T12) who have an American Spinal Injury Association AIS-A level of impairment, between one and two years post injury. These patients exhibit no motor or sensory function in the relevant segments at and below the injury, and are considered to be in complete paralysis. Study patients will receive six injections in, or around, the injury site: the first four patients will receive 100,000 cells per injection; the second four patients, 200,000 cells per injection. All NSI-566/cSCI patients will receive post-surgery physical therapy, as well as immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient. The primary objective of the study is to determine the safety and toxicity of NSI-566 for the treatment of paralysis and related symptoms due to cSCI. The secondary objectives are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression.
In January, Neuralstem received issuance of U.S. Patent #8,362,262, Divisional Compositions and Methods of Use, part of the small molecule IP; additionally, issuance of PCT Patent #2337517, Floating Cannula and Method of Use, which is exclusively licensed by Neuralstem, and validated in four European countries: Germany, France, Italy and United Kingdom, for a total of five European patents.
In February, Neuralstem's NSI-566 Phase I Clinical Trial in ALS (amyotrophic lateral sclerosis, or Lou Gehrig 's disease) officially concluded, six months after the final surgery at Emory University Hospital.
In February, Neuralstem granted liPage: 1 2 3 4 5 6 7 8 9 Related biology technology :1
. Neuralstem Announces 2012 Financial Results, Provides Clinical Trials Update2
. Neuralstem Cells Induce Significant Functional Improvement In Permanent Rat Spinal Cord Injury, Cell Study Reports3
. Neuralstem President And CEO To Present At The 2012 Rodman & Renshaw Annual Healthcare Conference4
. Neuralstem Receives Notice Of Issuance For Patent Covering Human Neural Cell Transplantation For Neurodegenerative Conditions5
. Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London6
. Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial7
. Neuralstem Announces Closing of $5.2-Million Registered Direct Offering8
. Neuralstem President and CEO to Present at BIO CEO & Investor Conference 20129
. Neuralstem President and CEO to Update Ongoing ALS and NSI-189/Major Depressive Disorder Trials at 2012 Biotech Showcase10
. Neuralstem ALS Stem Cell Trial Featured on Fox Atlanta11
. Inovio Pharmaceuticals Reports 2013 First Quarter Financial Results