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Clinical Development of MultiStem® for the Treatment of CNS Injury and Disease

Tuesday, 23 April 2013 at 10:00

Add to Calendar ▼2013-04-23 10:00:002013-04-23 11:00:00Europe/LondonClinical Development of MultiStem® for the Treatment of CNS Injury and DiseaseClinical Translation of Stem Cells Summit in Palm Springs, CA, USAPalm Springs, CA, USASELECTBIOenquiries@selectbiosciences.com

Athersys, Inc. is developing MultiStem®, a proprietary adult stem cell product, for the treatment of multiple disease indications. Athersys has undertaken extensive safety profiling of MultiStem in pre-clinical animal studies. Athersys has developed a clinical manufacturing platform for MultiStem and has filed and received authorization of Investigational New Drug (IND) applications for using MultiStem in 4 different indications including: Acute Myocardial Infarction (AMI), prophylaxis against graft vs. host disease (GVHD) and in treatment of ulcerative colitis in an ongoing Phase II study with Pfizer.  

Athersys and collaborators have performed focused pre-clinical animal studies to address the mechanisms of action through which MultiStem provides benefit in models of ischemic stroke and other CNS injury and disease. Comparative microarray analysis of RNA isolated from the infarct region of stroke injured rats receiving cells vs. placebo indicates that cell treated animals have a statistically significant decrease in the expression pattern of transcripts associated with infiltrating activated immune cells. From these data, and similar data we have published testing MultiStem in models of traumatic brain injury and spinal cord injury, we hypothesize systemic administration of MultiStem provides protection to "at risk" neuronal tissues by slowing/halting the acute inflammatory response and mobilization of peripheral immune cells to the injury.

More recently, we filed for and received authorization of IND application #13852, a Phase I/II clinical study testing MultiStem in patients suffering an acute ischemic stroke. We have completed Phase I, a dose escalation safety study to determine the highest tolerated dose of MultiStem up to a maximum of 1.2 Billion cells per patient, and will begin enrollment of patients in Phase II of the study in the immediate near future.