Development of an allogeneic adherent stem cell therapy for treatment of ischemic stroke

A Double-Blind Placebo-Controlled Clinical Evaluation of Multistem for the Treatment of Ischemic Stroke

“…Because there is prior evidence for safety of MultiStem cells when administered to patients who have suffered myocardial infarction or that are at significant risk of graft vs. host disease, the current study will involve dose escalation up to a target dose of 1·2 billion cells. This dose equates to the ‘human’ dose equivalent of the most effective dose of MultiStem cells in a rat ischemic stroke model .…”

“…Athersys convened a Clinical Advisory Group to advise on trial design. Based on preclinical studies in a rat ischemic stroke model, the time period of 24–36 h after stroke onset was chosen . This time window targets both a late neuroprotective window and the early reparative and remodeling processes.…”

“…Athersys, Inc. has developed a clinical scale expansion process based on modifications of this platform . MultiStem administration improves outcomes in animal models of neonatal hypoxic–ischemic encephalopathy and in focal ischemia in adult rodents and has also been demonstrated to interrupt and attenuate inflammatory cascades in rodent models of traumatic brain injury and spinal cord injury, as well as to provide neurotrophic and/or neuroprotective benefits .…”

“…MultiStem cells do not induce allogeneic T cell responses in vitro . In a rat ischemic stroke model, MultiStem allogeneic rat cells and xenogeneic human cells administered without immunosuppression promote significant and durable recovery poststroke injury .…”

Adult adherent cell therapy for ischemic stroke: clinical results and development experience using MultiStem

“…In light of this significant unmet clinical need, Athersys has developed a cell therapeutic, MultiStem, as a platform for treating acute central nervous system injury including stroke, traumatic brain injury, and spinal cord injury. [1][2][3][4][5][6] The therapeutic premise reflects the strong immunomodulatory and anti-inflammatory influence shown by adherent (mesenchymal stromal cell-like) stem cells and posits that administration of MultiStem early after injury can diminish the systemic inflammatory response contributing to significant pathology and comorbidity in stroke. This hypothesis is supported by preclinical data demonstrating the role of splenic lymphocytes in onset of stroke pathology.…”