Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)

What is the purpose of this trial?

This clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory T-cells on beta cell function in patients, aged 8 to 17, with recent onset T1DM. Other measures of diabetes severity and the autoimmune response underlying T1DM will also be explored. Eligible subjects will receive a single infusion of CLBS03 (high or low dose) or placebo.

Participation Guidelines

Ages: 8 - 17 years

Gender: Both

Caladrius Biosciences, Inc.

Dates: 05/24/2017 - 03/31/2019

Last Updated: 08/09/2017

Study HIC#: 2000020286

Get Involved

For more information about this study, contact:
Naomi Simone Yama
+1 203-737-2737

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 1-877-978-8348.

Trial Image


Kevan Herold

Principal Investigator