Athersys Trial for MultiStem Authorized
The FDA will allow Athersys to proceed with a Phase I trial evaluating the safety of MultiStem administration for the treatment of certain cancers of the blood and immune system.
The study is the first of several planned clinical trials for MultiStem adult stem cells derived from bone marrow, which have the demonstrated ability to form a range of cell types.
The open-label, multicenter, dose-escalation study will evaluate the safety and maximum tolerated dose of single or multiple dose administration of allogeneic MultiStem in patients with acute leukemia, chronic myeloid leukemia or myelodysplasia. Patients will receive treatment following a bone marrow transplant conditioning regimen and hematopoietic stem cell transplantation, Athersys said.