Regulatory T-cells present in peripheral blood at \<20 cells per μL
Current or ongoing use of non-insulin pharmaceuticals (that may affect glycemic control)
Current or anticipated use of systemic corticosteroids or other immunomodulatory drugs
Recent serious bacterial, viral, fungal, or other opportunistic infections
History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease
Serologic evidence of current or past viral infection: human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, and human T-lymphotropic virus (HTLV) 1/2
Positive QuantiFERON® tuberculosis (TB) test, purified protein derivative (PPD) skin test, history of tuberculosis, or active TB infection
Active infection with Epstein-Barr Virus or Cytomegalovirus
Liver disease
Pregnant or breast-feeding
Vaccination with a live virus within 8 weeks of receipt of study drug
Vaccination with a killed virus within 2 weeks of receipt of study drug
Participation in an investigational drug study within 90 days prior to screening
Previously treated with a T-Reg based cell therapy
History of allergy to gentamicin
Clareo Health | Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study)
