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
- 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.