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

Exclusion Criteria

• •Hemoglobin less than the lower limit of normal
• •Leukocytes \<3,000/μL; neutrophils \<1,500/μL; lymphocytes \<800/μL; platelets \<100,000/μL
• •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