UCMSCs Combined With Standard Therapy for the Treatment of Newly Diagnosed Type 1 Diabetes

Summary

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

Eligibility

Inclusion Criteria:

1. Meets the diagnostic criteria for diabetes according to the World Health Organization (WHO) guidelines from 1999.
2. Presence of at least one pancreatic autoantibody, or idiopathic type 1 diabetes mellitus (T1DM) with negative autoantibody testing.
3. Ages 8 to 18 years, regardless of gender.
4. Newly diagnosed T1DM within the past 6 months.
5. Fasting C-peptide ≥0.1 nmol/L and postprandial 2-hour C-peptide \>0.2 nmol/L.
6. Voluntary acceptance of stem cell transplantation therapy by the individual, their family members, or legal guardians, and signing of an informed consent form.

Exclusion Criteria:

1. Diabetic ketoacidosis is not under control.
2. Severe allergic constitution.
3. BMI \<14 or \>35.
4. History of other autoimmune diseases, hematologic disorders.
5. HIV positive, carrier of viral hepatitis, active phase of viral hepatitis, or other uncontrolled infectious diseases.
6. History of acute pancreatitis, pulmonary embolism, or other thrombotic diseases, as well as severe diseases of the heart, liver, kidneys, respiratory system, nervous system, etc.
7. Suffering from gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction, or acromegaly-induced diabetes);
8. Pregnancy or planning pregnancy within 3 months before or after treatment, as well as breastfeeding women.
9. Mental illness, alcohol or drug abuse, inability to comply with treatment.
10. Known or suspected tumors.
11. According to the investigator's judgment, there are other clinical conditions that may endanger the safety of the subjects.

Conditions2

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