Investigation of Dose Escalation and Cohort Expansion Study on the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells(UCMSCs) Combined With Standard Therapy for Newly Diagnosed Type 1 Diabetes
The aim is to investigate the safety and tolerability of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells in pediatric patients diagnosed with newly onset type 1 diabetes
• Meets the diagnostic criteria for diabetes according to the World Health Organization (WHO) guidelines from 1999.
• Presence of at least one pancreatic autoantibody, or idiopathic type 1 diabetes mellitus (T1DM) with negative autoantibody testing.
• Ages 8 to 18 years, regardless of gender.
• Newly diagnosed T1DM within the past 6 months.
• Fasting C-peptide ≥0.1 nmol/L and postprandial 2-hour C-peptide \>0.2 nmol/L.
• Voluntary acceptance of stem cell transplantation therapy by the individual, their family members, or legal guardians, and signing of an informed consent form.