A Prospective, Open Label, Controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI) Due to Arteriosclerosis Obliterans (ASO) With a Single-arm Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients With CLI Due to Buerger's Disease (BD)

Trial Profile

A Prospective, Open Label, Controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI) Due to Arteriosclerosis Obliterans (ASO) With a Single-arm Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients With CLI Due to Buerger's Disease (BD)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Mar 2018

At a glance

  • Drugs CLBS 12 (Primary)
  • Indications Arteriosclerosis obliterans; Peripheral ischaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Caladrius Biosciences
  • Most Recent Events

    • 13 Mar 2018 According to a Caladrius Biosciences media release, the first patient has been dosed in this study.
    • 22 Dec 2017 Status changed from not yet recruiting to recruiting.
    • 01 Nov 2017 According to a Caladrius Biosciences media release, a successful outcome of this trial will qualify the program for early conditional approval based on discussions with the Japanese regulatory authorities as provided for under Japan's progressive regenerative medicine regulations. This trial is about to initiate in Japan.
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