The first patient has been dosed in a Phase 2 clinical trial in Japan evaluating Caladrius Biosciences' (NASDAQ:CLBS) CLBS12, a CD34 cell therapy, in patients with no-option critical limb ischemia (CLI) (severely restricted blood flow to the extremities).
The 35-subject study will compare CLBS12 + standard-of-care (SOC) drug therapy to SOC drug therapy alone. The primary endpoint is the time to continuous CLI-free status.
If successful, the company plans to apply for conditional approval there for the indication.
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