Caladrius doses first patient with CLBS12 in Phase 2 CLI trial
Caladrius Biosciences announces that the first patient has been dosed in the company's Phase 2 clinical trial in Japan with its proprietary CD34 cell therapy, CLBS12, for the treatment of no-option critical limb ischemia , or CLI. This trial is a 35-patient prospective, randomized, controlled, multicenter study. Patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34 cells, CLBS12, through intramuscular injection, in addition to receiving standard of care pharmacotherapy. Patients randomized to the control arm will receive standard of care pharmacotherapy alone. The primary endpoint is time to continuous CLI-free status, defined as two consecutive monthly visits in which the patient is determined by an independent adjudication committee to be "CLI-free".