A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal Regulatory T-cells) in Adolescents With Recent Onset Type 1 Diabetes Mellitus (T1DM)

Trial Profile

A Prospective Randomized Placebo-Controlled Double Blind Clinical Trial to Evaluate the Safety and Efficacy of CLBS03 (Autologous Ex Vivo Expanded Polyclonal Regulatory T-cells) in Adolescents With Recent Onset Type 1 Diabetes Mellitus (T1DM)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Mar 2018

At a glance

  • Drugs NBS 03 (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Proof of concept; Therapeutic Use
  • Acronyms T-Rex
  • Sponsors Caladrius Biosciences
  • Most Recent Events

    • 08 Mar 2018 According to a Caladrius Biosciences media release, a pre-planned interim analysis, showed that CLBS03 continues to be well-tolerated and led to the conclusion that the study was non-futile as determined by pre-defined futility criteria for therapeutic effect. Company expects to report 12-month follow-up data in 110 patients in early 2019.
    • 18 Jan 2018 According to a Caladrius Biosciences media release, topline data from the primary endpoint of the completed study in early 2019.
    • 12 Jan 2018 Status changed from recruiting to active, no longer recruiting.
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