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)
Phase of Trial: Phase II
Latest Information Update: 21 Sep 2017
At a glance
- Drugs NBS 03 (Primary)
- Indications Type 1 diabetes mellitus
- Focus Pharmacokinetics; Proof of concept
- Acronyms T-Rex
- Sponsors Caladrius Biosciences
- 05 Sep 2017 According to a Caladrius Biosciences media release, the 70th subject has been enrolled in this trial. Enrollment of the first cohort (n=19) was completed in August 2016 and enrollment of the second cohort initiated in October 2016.
- 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.