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)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 10 Aug 2017

At a glance

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

    • 10 Aug 2017 According to a Caladrius Biosciences media release, the company expects to announce topline results from pre-specified interim analysis of 50% subjects during the first quarter of 2018 and enrollment completion by the end of 2017.
    • 19 Jul 2017 According to a Caladrius Biosciences media release, 50% of subjects have been treated.
    • 10 Jun 2017 Biomarkers information updated
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