According to a recent news release, early results yielding from a Phase II intra-arterial stem cell trial for ischemic stroke exhibited no adverse events in the trial’s first 10 patients. The positive results will allow researchers to expand the study to encompass a targeted total of 100 patients.
Sean Savitz, MD, professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth) reportedly presented the results at the October 11 8th World Stroke Congress in Brasilia, Brazil. Researchers not that the study is designed to assess the safety and efficacy of a regenerative therapy developed by Aldagen Inc, subsidiary of Cytomedix Inc. The therapy, ALD-401, is engineered to use the patient’s own bone marrow stem cells and can be administered between 13 days and 19 days post-stroke. Researchers add that pre-clinical studies suggest the therapy showed promise in mouse models, enhancing recovery after stroke.
Savitz notes that, “We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollement.” The release also notes that the Food and Drug Administration requires a review by the DSMB prior to allowing the study to advance to its next phase.
Source: University of Texas Health Science Center at Houston