Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, autoimmune, cord blood stem cell, stem cell educator, immune modulation, children, Control autoimmunity, stimulate the regeneration of islet beta cells
Eligibility Criteria
Inclusion Criteria:
1. T1D patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of American Diabetes Association.
2. Children from 3 through 18 years old and body weight > 15 kg.
3. Presence of at least one autoantibody to the pancreatic islet β cells (IA-2, GAD, ICA, ZnT8, or IAA).
4. Written informed consent from the child and child's parents or legal representative.
Exclusion Criteria:
1. Any clinically significant diseases in liver, kidney, and heart.
2. Additional exclusion criteria include no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency
3. Significantly abnormal hematology results at screening.
4. Presence of any infection diseases or inflammation conditions, including active skin infections, flu, fever, upper or lower respiratory track infections.
Sites / Locations
- The Second Xiangya HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Cord Blood-derived multipotent stem cells
Human cord blood-derived multipotent stem cells (CB-SC) display unique phenotypes, such as the expression of embryonic stem (ES) cell markers, multipotential of differentiations, very low immunogenecity, and immune modulations in patients.