Exploratory Study of CLBS03 in Children with Recent Onset T1D


​This study aims to assess if one's own expanded regulatory T cells can rebalance the immune system, decreasing the attack on the insulin-producing cells in type 1 diabetes.

Regulatory T cells (Tregs) are a type of immune cell that maintains tolerance to self-antigens, preventing autoimmune disease. In this study, blood will be collected from children recently diagnosed with type 1 diabetes (T1D) and used as a source to grow Tregs in the lab. These lab-grown Tregs will be returned to the participant to try and rebalance the immune system, decreasing the autoimmune attack on the insulin-producing beta cells. Participants will receive either one of two different doses of Tregs or a placebo infusion.

This study involves:

  • 2-year commitment
  • 12 periodic visits including blood draws and mixed meal tolerance tests
  • Intensive diabetes management

Recruitment: This study is not currently recruiting.

This study is no longer recruiting participants.


Principal Investigator: Dr. Jason Gaglia