Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
Trial Parameters
Brief Summary
The brief purpose of this research study is to learn about the safety and efficacy of intra-arterial administration of CELZ-201 in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D).
Eligibility Criteria
Inclusion Criteria: 1. Subject must be able to understand and provide signed informed consent. 2. Males and females, 18-35 years of age. 3. Diagnosis of T1D within 1 year, with stimulated C-peptide peak level \>0.6 ng/mL as assessed by 4-hour MMTT at the time of Visit 0 (screening). 4. Diagnosed with T1D, according to ADA standard criteria, and confirmed by positivity to at least two islet autoantibodies, GAD65, IA-2, or ZnT8. 5. Mentally stable and able to comply with the procedures of the study protocol 6. Subjects must be willing to comply with "standard-of-care" diabetes management. 7. Subjects with eGFR \>80 ml/min/1.73m2 8. Female subjects of childbearing potential must have a negative pregnancy test upon study entry. 9. Female (and male) subjects with reproductive potential must agree to use two FDA approved methods of birth control for the entire duration of the study. Potential subjects of childbearing potential should agree to use effective contraception for the entire 2-year