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Caladrius Biosciences (CLBS) Doses1st patient with CLBS12 in P2 Critical Limb Ischemia (CLI) Trial in Japan

March 13, 2018 11:44am

... In CLBS’ P2 clinical trial is for the treatment of no-option CLI. The stock is up +$0.19 or +3.39% to $5.80 – SELL into strength and news while reviewing the technicals and chart …

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”.

Based on discussions with the Japanese regulatory authorities and in accordance with the Japanese Pharmaceuticals and Medical Devices Law passed in November 2014…

CLBS “believes” that, with favorable results, the study will qualify for consideration of conditional approval for CLBS12 in Japan for the treatment of no-option CLI?

The noted legislation expedites the development and commercialization of regenerative medicine therapies and grants conditional approval for regenerative medicines that demonstrate evidence for safety and the likelihood for efficacy.

Don't count your chickens until there hatched ...

35 companies, 1 interpreter!

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