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)

Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2017

At a glance

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

    • 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.
    • 18 Apr 2016 According to a media release, Caladrius Biosciences expects to initiate this trial in late 2016.
    • 18 Apr 2016 According to a Caladrius Biosciences media release, the Japanese Pharmaceutical and Medical Devices Agency's (PMDA) thirty-day review period of the Company's Clinical Trial Notification (CTN) for this trial has passed without further comment from the agency and the company is allowed to proceed with this trial.
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