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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)

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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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 Sep 2022

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At a glance

  • Drugs NBS 03 (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Caladrius Biosciences

Most Recent Events

  • 21 Jul 2020 Status changed from active, no longer recruiting to completed.
  • 13 Feb 2019 According to a Caladrius Biosciences media release, the database from this study is very large and the analysis and interpretation of all the information will require several months of intensive evaluation and will be critical to the decision regarding the next steps in development of CLBS03. In addition, the data from the 2-year follow-up, once complete, will afford supplemental information and are necessary to complete the evaluation of this therapy.
  • 13 Feb 2019 According to a Caladrius Biosciences media release, top-line results (initial analysis of the 1-year follow-up data) from this study were announced today.

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